Overactive bladder (OAB) is a highly prevalent syndrome associated with significant bother and impact on quality of life. The mainstay of pharmacotherapy for OAB has been based on antimuscarinic drugs. It has been shown that antimuscarinic agents are more effective than placebo in reducing symptoms and in improving health-related quality of life [1]. Nevertheless, adherence and persistence for antimuscarinic therapy are very low, with rates of only 12.0–39.4% after 12 mo reported [2]. Patients abandon treatment because of unrealistic expectations regarding drug efficacy and bothersome side effects such as dry mouth and constipation. These undesirable symptoms occur more frequently for higher antimuscarinic doses, although their severity is not dose-dependent [3].
The introduction of mirabegron, a β3-adrenoceptor agonist, offers an alternative option for OAB patients who do not respond to or tolerate antimuscarinic drugs because of its different mechanism of action. Stimulation of β3-adrenoceptors results in direct relaxation of detrusor smooth muscle via activation of G proteins and adenyl cyclase, increasing levels of cyclic adenosine monophosphate and increasing bladder storage capacity [4].
Mirabegron is the first of a new class of agents developed for the treatment of OAB. The efficacy of mirabegron 50 mg is similar to that of most approved antimuscarinics in reducing OAB symptoms. However, mirabegron has a better tolerability profile than antimuscarinics, with an incidence of dry mouth and constipation similar to that for placebo, and a significantly lower rate of dry mouth compared to all antimuscarinics [5]. Only solifenacin 10 mg has shown significantly superior efficacy in improving micturition and decreasing episodes of urgency urinary incontinence in comparison to mirabegron 50 mg [5].
In this issue of European Urology, Drake et al [6] report results for the BESIDE study, a randomised, double-blind, multicentre phase 3B trial evaluating the efficacy, safety, and tolerability of a combination of solifenacin 5 mg and mirabegron 50 mg compared to solifenacin 5 or 10 mg in OAB patients remaining incontinent after 4 wk of treatment with solifenacin 5 mg. At the end of the treatment it was observed that the combination therapy was significantly superior to solifenacin 5 mg, with meaningful improvements in daily incontinence, daily number of micturitions, and incontinence noted in a 3-d diary. However, the combination therapy was noninferior to solifenacin 10 mg for key secondary endpoints and superior to solifenacin 10 mg in improving daily micturitions. The authors conclude that adding mirabegron 50 mg to solifenacin 5 mg further improved OAB symptoms compared to solifenacin 5 or 10 mg, and it was well tolerated in OAB patients remaining incontinent after initial therapy with solifenacin 5 mg.
Combination therapy for lower urinary tract symptoms (LUTS) is not new. Medical management of men with moderate to severe LUTS due to benign prostatic hyperplasia with α-blockers and 5-α reductase inhibitors (5-ARIs) is effective not only in improving LUTS but also in reducing the relative risk of disease progression [7]. More recently, it was shown that a combination of solifenacin and tamsulosin was efficacious in improving symptoms in patients who did not respond initially to α-blocker therapy [8]. The aim of these combinations is to add different mechanisms of actions to achieve an improvement in patient quality of life, which should involve control of symptoms with the lowest rate of adverse events.
In the study by Drake et al, the incidence of treatment emergent adverse events (TEAEs) was lowest for solifenacin 5 mg (33.1%), highest for solifenacin 10 mg (39.4%), and 35.9% for the combination. The incidence of dry mouth, the most common TEAE of antimuscarinics, was lower for the combination (5.9%) than for solifenacin 10 mg (9.5%) and similar to solifenacin 5 mg (5.6%). A general mean rise of 1 mm Hg in systolic blood pressure was observed between the combination and solifenacin monotherapy at end of treatment, which is attributable to mirabegron. There were no significant differences in vital signs, including subpopulations stratified by hypertensive status and β-blocker use, nor were there notable cardiovascular changes. A recent systematic review addressing the cardiovascular safety of β3-adrenoceptor agonists for the treatment of patients with OAB found that the cardiovascular safety of mirabegron appears to be good and comparable to that of antimuscarinic agents. However, because data for patients with poorly controlled hypertension, arrhythmia, or cardiac heart failure are currently lacking, periodic blood pressure and heart rate measurements are recommended for patients with significant cardiovascular risk factors, such as coronary heart disease and cardiomyopathy, and those aged >80 yr [9].
The findings reported by Drake et al suggest that combination therapy of solifenacin 5 mg and mirabegron 50 mg may be an alternative to dose escalation of solifenacin in patients with insufficient response to solifenacin 5 mg.
OAB is a complex condition affecting different patients who may be treated with different pharmacotherapy options and exhibit different responses. Some patients may primarily respond very well to initial therapy, while others do not. Combination therapy of solifenacin and mirabegron may contribute in optimising efficacy with an acceptable tolerability profile in comparison to a higher antimuscarinic dose. This approach may provide greater patient satisfaction, contributing to higher adherence and persistence rates and yielding a better efficacy-tolerability balance.
Barbara Padilla-Fernandez has received travel grants from Astellas, Almirall, and GebroPharma. David Castro-Diaz has been an investigator for Astellas and Allergan and a speaker for Astellas, Allergan, Pfizer, Medtronic, and Neo-Medic.
Overactive bladder (OAB) is a highly prevalent syndrome associated with significant bother and impact on quality of life. The mainstay of pharmacotherapy for OAB has been based on antimuscarinic drugs. It has been shown that antimuscarinic agents are more effective than placebo in reducing symptoms and in improving health-related quality of life [1]. Nevertheless, adherence and persistence for antimuscarinic therapy are very low, with rates of only 12.0–39.4% after 12 mo reported [2]. Patients abandon treatment because of unrealistic expectations regarding drug efficacy and bothersome side effects such as dry mouth and constipation. These undesirable symptoms occur more frequently for higher antimuscarinic doses, although their severity is not dose-dependent [3].
The introduction of mirabegron, a β3-adrenoceptor agonist, offers an alternative option for OAB patients who do not respond to or tolerate antimuscarinic drugs because of its different mechanism of action. Stimulation of β3-adrenoceptors results in direct relaxation of detrusor smooth muscle via activation of G proteins and adenyl cyclase, increasing levels of cyclic adenosine monophosphate and increasing bladder storage capacity [4].
Mirabegron is the first of a new class of agents developed for the treatment of OAB. The efficacy of mirabegron 50 mg is similar to that of most approved antimuscarinics in reducing OAB symptoms. However, mirabegron has a better tolerability profile than antimuscarinics, with an incidence of dry mouth and constipation similar to that for placebo, and a significantly lower rate of dry mouth compared to all antimuscarinics [5]. Only solifenacin 10 mg has shown significantly superior efficacy in improving micturition and decreasing episodes of urgency urinary incontinence in comparison to mirabegron 50 mg [5].
In this issue of European Urology, Drake et al [6] report results for the BESIDE study, a randomised, double-blind, multicentre phase 3B trial evaluating the efficacy, safety, and tolerability of a combination of solifenacin 5 mg and mirabegron 50 mg compared to solifenacin 5 or 10 mg in OAB patients remaining incontinent after 4 wk of treatment with solifenacin 5 mg. At the end of the treatment it was observed that the combination therapy was significantly superior to solifenacin 5 mg, with meaningful improvements in daily incontinence, daily number of micturitions, and incontinence noted in a 3-d diary. However, the combination therapy was noninferior to solifenacin 10 mg for key secondary endpoints and superior to solifenacin 10 mg in improving daily micturitions. The authors conclude that adding mirabegron 50 mg to solifenacin 5 mg further improved OAB symptoms compared to solifenacin 5 or 10 mg, and it was well tolerated in OAB patients remaining incontinent after initial therapy with solifenacin 5 mg.
Combination therapy for lower urinary tract symptoms (LUTS) is not new. Medical management of men with moderate to severe LUTS due to benign prostatic hyperplasia with α-blockers and 5-α reductase inhibitors (5-ARIs) is effective not only in improving LUTS but also in reducing the relative risk of disease progression [7]. More recently, it was shown that a combination of solifenacin and tamsulosin was efficacious in improving symptoms in patients who did not respond initially to α-blocker therapy [8]. The aim of these combinations is to add different mechanisms of actions to achieve an improvement in patient quality of life, which should involve control of symptoms with the lowest rate of adverse events.
In the study by Drake et al, the incidence of treatment emergent adverse events (TEAEs) was lowest for solifenacin 5 mg (33.1%), highest for solifenacin 10 mg (39.4%), and 35.9% for the combination. The incidence of dry mouth, the most common TEAE of antimuscarinics, was lower for the combination (5.9%) than for solifenacin 10 mg (9.5%) and similar to solifenacin 5 mg (5.6%). A general mean rise of 1 mm Hg in systolic blood pressure was observed between the combination and solifenacin monotherapy at end of treatment, which is attributable to mirabegron. There were no significant differences in vital signs, including subpopulations stratified by hypertensive status and β-blocker use, nor were there notable cardiovascular changes. A recent systematic review addressing the cardiovascular safety of β3-adrenoceptor agonists for the treatment of patients with OAB found that the cardiovascular safety of mirabegron appears to be good and comparable to that of antimuscarinic agents. However, because data for patients with poorly controlled hypertension, arrhythmia, or cardiac heart failure are currently lacking, periodic blood pressure and heart rate measurements are recommended for patients with significant cardiovascular risk factors, such as coronary heart disease and cardiomyopathy, and those aged >80 yr [9].
The findings reported by Drake et al suggest that combination therapy of solifenacin 5 mg and mirabegron 50 mg may be an alternative to dose escalation of solifenacin in patients with insufficient response to solifenacin 5 mg.
OAB is a complex condition affecting different patients who may be treated with different pharmacotherapy options and exhibit different responses. Some patients may primarily respond very well to initial therapy, while others do not. Combination therapy of solifenacin and mirabegron may contribute in optimising efficacy with an acceptable tolerability profile in comparison to a higher antimuscarinic dose. This approach may provide greater patient satisfaction, contributing to higher adherence and persistence rates and yielding a better efficacy-tolerability balance.
Barbara Padilla-Fernandez has received travel grants from Astellas, Almirall, and GebroPharma. David Castro-Diaz has been an investigator for Astellas and Allergan and a speaker for Astellas, Allergan, Pfizer, Medtronic, and Neo-Medic.
Overactive bladder (OAB) is a highly prevalent syndrome associated with significant bother and impact on quality of life. The mainstay of pharmacotherapy for OAB has been based on antimuscarinic drugs. It has been shown that antimuscarinic agents are more effective than placebo in reducing symptoms and in improving health-related quality of life [1]. Nevertheless, adherence and persistence for antimuscarinic therapy are very low, with rates of only 12.0–39.4% after 12 mo reported [2]. Patients abandon treatment because of unrealistic expectations regarding drug efficacy and bothersome side effects such as dry mouth and constipation. These undesirable symptoms occur more frequently for higher antimuscarinic doses, although their severity is not dose-dependent [3].
The introduction of mirabegron, a β3-adrenoceptor agonist, offers an alternative option for OAB patients who do not respond to or tolerate antimuscarinic drugs because of its different mechanism of action. Stimulation of β3-adrenoceptors results in direct relaxation of detrusor smooth muscle via activation of G proteins and adenyl cyclase, increasing levels of cyclic adenosine monophosphate and increasing bladder storage capacity [4].
Mirabegron is the first of a new class of agents developed for the treatment of OAB. The efficacy of mirabegron 50 mg is similar to that of most approved antimuscarinics in reducing OAB symptoms. However, mirabegron has a better tolerability profile than antimuscarinics, with an incidence of dry mouth and constipation similar to that for placebo, and a significantly lower rate of dry mouth compared to all antimuscarinics [5]. Only solifenacin 10 mg has shown significantly superior efficacy in improving micturition and decreasing episodes of urgency urinary incontinence in comparison to mirabegron 50 mg [5].
In this issue of European Urology, Drake et al [6] report results for the BESIDE study, a randomised, double-blind, multicentre phase 3B trial evaluating the efficacy, safety, and tolerability of a combination of solifenacin 5 mg and mirabegron 50 mg compared to solifenacin 5 or 10 mg in OAB patients remaining incontinent after 4 wk of treatment with solifenacin 5 mg. At the end of the treatment it was observed that the combination therapy was significantly superior to solifenacin 5 mg, with meaningful improvements in daily incontinence, daily number of micturitions, and incontinence noted in a 3-d diary. However, the combination therapy was noninferior to solifenacin 10 mg for key secondary endpoints and superior to solifenacin 10 mg in improving daily micturitions. The authors conclude that adding mirabegron 50 mg to solifenacin 5 mg further improved OAB symptoms compared to solifenacin 5 or 10 mg, and it was well tolerated in OAB patients remaining incontinent after initial therapy with solifenacin 5 mg.
Combination therapy for lower urinary tract symptoms (LUTS) is not new. Medical management of men with moderate to severe LUTS due to benign prostatic hyperplasia with α-blockers and 5-α reductase inhibitors (5-ARIs) is effective not only in improving LUTS but also in reducing the relative risk of disease progression [7]. More recently, it was shown that a combination of solifenacin and tamsulosin was efficacious in improving symptoms in patients who did not respond initially to α-blocker therapy [8]. The aim of these combinations is to add different mechanisms of actions to achieve an improvement in patient quality of life, which should involve control of symptoms with the lowest rate of adverse events.
In the study by Drake et al, the incidence of treatment emergent adverse events (TEAEs) was lowest for solifenacin 5 mg (33.1%), highest for solifenacin 10 mg (39.4%), and 35.9% for the combination. The incidence of dry mouth, the most common TEAE of antimuscarinics, was lower for the combination (5.9%) than for solifenacin 10 mg (9.5%) and similar to solifenacin 5 mg (5.6%). A general mean rise of 1 mm Hg in systolic blood pressure was observed between the combination and solifenacin monotherapy at end of treatment, which is attributable to mirabegron. There were no significant differences in vital signs, including subpopulations stratified by hypertensive status and β-blocker use, nor were there notable cardiovascular changes. A recent systematic review addressing the cardiovascular safety of β3-adrenoceptor agonists for the treatment of patients with OAB found that the cardiovascular safety of mirabegron appears to be good and comparable to that of antimuscarinic agents. However, because data for patients with poorly controlled hypertension, arrhythmia, or cardiac heart failure are currently lacking, periodic blood pressure and heart rate measurements are recommended for patients with significant cardiovascular risk factors, such as coronary heart disease and cardiomyopathy, and those aged >80 yr [9].
The findings reported by Drake et al suggest that combination therapy of solifenacin 5 mg and mirabegron 50 mg may be an alternative to dose escalation of solifenacin in patients with insufficient response to solifenacin 5 mg.
OAB is a complex condition affecting different patients who may be treated with different pharmacotherapy options and exhibit different responses. Some patients may primarily respond very well to initial therapy, while others do not. Combination therapy of solifenacin and mirabegron may contribute in optimising efficacy with an acceptable tolerability profile in comparison to a higher antimuscarinic dose. This approach may provide greater patient satisfaction, contributing to higher adherence and persistence rates and yielding a better efficacy-tolerability balance.
Barbara Padilla-Fernandez has received travel grants from Astellas, Almirall, and GebroPharma. David Castro-Diaz has been an investigator for Astellas and Allergan and a speaker for Astellas, Allergan, Pfizer, Medtronic, and Neo-Medic.
Overactive bladder (OAB) is a highly prevalent syndrome associated with significant bother and impact on quality of life. The mainstay of pharmacotherapy for OAB has been based on antimuscarinic drugs. It has been shown that antimuscarinic agents are more effective than placebo in reducing symptoms and in improving health-related quality of life [1]. Nevertheless, adherence and persistence for antimuscarinic therapy are very low, with rates of only 12.0–39.4% after 12 mo reported [2]. Patients abandon treatment because of unrealistic expectations regarding drug efficacy and bothersome side effects such as dry mouth and constipation. These undesirable symptoms occur more frequently for higher antimuscarinic doses, although their severity is not dose-dependent [3].
The introduction of mirabegron, a β3-adrenoceptor agonist, offers an alternative option for OAB patients who do not respond to or tolerate antimuscarinic drugs because of its different mechanism of action. Stimulation of β3-adrenoceptors results in direct relaxation of detrusor smooth muscle via activation of G proteins and adenyl cyclase, increasing levels of cyclic adenosine monophosphate and increasing bladder storage capacity [4].
Mirabegron is the first of a new class of agents developed for the treatment of OAB. The efficacy of mirabegron 50 mg is similar to that of most approved antimuscarinics in reducing OAB symptoms. However, mirabegron has a better tolerability profile than antimuscarinics, with an incidence of dry mouth and constipation similar to that for placebo, and a significantly lower rate of dry mouth compared to all antimuscarinics [5]. Only solifenacin 10 mg has shown significantly superior efficacy in improving micturition and decreasing episodes of urgency urinary incontinence in comparison to mirabegron 50 mg [5].
In this issue of European Urology, Drake et al [6] report results for the BESIDE study, a randomised, double-blind, multicentre phase 3B trial evaluating the efficacy, safety, and tolerability of a combination of solifenacin 5 mg and mirabegron 50 mg compared to solifenacin 5 or 10 mg in OAB patients remaining incontinent after 4 wk of treatment with solifenacin 5 mg. At the end of the treatment it was observed that the combination therapy was significantly superior to solifenacin 5 mg, with meaningful improvements in daily incontinence, daily number of micturitions, and incontinence noted in a 3-d diary. However, the combination therapy was noninferior to solifenacin 10 mg for key secondary endpoints and superior to solifenacin 10 mg in improving daily micturitions. The authors conclude that adding mirabegron 50 mg to solifenacin 5 mg further improved OAB symptoms compared to solifenacin 5 or 10 mg, and it was well tolerated in OAB patients remaining incontinent after initial therapy with solifenacin 5 mg.
Combination therapy for lower urinary tract symptoms (LUTS) is not new. Medical management of men with moderate to severe LUTS due to benign prostatic hyperplasia with α-blockers and 5-α reductase inhibitors (5-ARIs) is effective not only in improving LUTS but also in reducing the relative risk of disease progression [7]. More recently, it was shown that a combination of solifenacin and tamsulosin was efficacious in improving symptoms in patients who did not respond initially to α-blocker therapy [8]. The aim of these combinations is to add different mechanisms of actions to achieve an improvement in patient quality of life, which should involve control of symptoms with the lowest rate of adverse events.
In the study by Drake et al, the incidence of treatment emergent adverse events (TEAEs) was lowest for solifenacin 5 mg (33.1%), highest for solifenacin 10 mg (39.4%), and 35.9% for the combination. The incidence of dry mouth, the most common TEAE of antimuscarinics, was lower for the combination (5.9%) than for solifenacin 10 mg (9.5%) and similar to solifenacin 5 mg (5.6%). A general mean rise of 1 mm Hg in systolic blood pressure was observed between the combination and solifenacin monotherapy at end of treatment, which is attributable to mirabegron. There were no significant differences in vital signs, including subpopulations stratified by hypertensive status and β-blocker use, nor were there notable cardiovascular changes. A recent systematic review addressing the cardiovascular safety of β3-adrenoceptor agonists for the treatment of patients with OAB found that the cardiovascular safety of mirabegron appears to be good and comparable to that of antimuscarinic agents. However, because data for patients with poorly controlled hypertension, arrhythmia, or cardiac heart failure are currently lacking, periodic blood pressure and heart rate measurements are recommended for patients with significant cardiovascular risk factors, such as coronary heart disease and cardiomyopathy, and those aged >80 yr [9].
The findings reported by Drake et al suggest that combination therapy of solifenacin 5 mg and mirabegron 50 mg may be an alternative to dose escalation of solifenacin in patients with insufficient response to solifenacin 5 mg.
OAB is a complex condition affecting different patients who may be treated with different pharmacotherapy options and exhibit different responses. Some patients may primarily respond very well to initial therapy, while others do not. Combination therapy of solifenacin and mirabegron may contribute in optimising efficacy with an acceptable tolerability profile in comparison to a higher antimuscarinic dose. This approach may provide greater patient satisfaction, contributing to higher adherence and persistence rates and yielding a better efficacy-tolerability balance.
Barbara Padilla-Fernandez has received travel grants from Astellas, Almirall, and GebroPharma. David Castro-Diaz has been an investigator for Astellas and Allergan and a speaker for Astellas, Allergan, Pfizer, Medtronic, and Neo-Medic.
Overactive bladder (OAB) is a highly prevalent syndrome associated with significant bother and impact on quality of life. The mainstay of pharmacotherapy for OAB has been based on antimuscarinic drugs. It has been shown that antimuscarinic agents are more effective than placebo in reducing symptoms and in improving health-related quality of life [1]. Nevertheless, adherence and persistence for antimuscarinic therapy are very low, with rates of only 12.0–39.4% after 12 mo reported [2]. Patients abandon treatment because of unrealistic expectations regarding drug efficacy and bothersome side effects such as dry mouth and constipation. These undesirable symptoms occur more frequently for higher antimuscarinic doses, although their severity is not dose-dependent [3].
The introduction of mirabegron, a β3-adrenoceptor agonist, offers an alternative option for OAB patients who do not respond to or tolerate antimuscarinic drugs because of its different mechanism of action. Stimulation of β3-adrenoceptors results in direct relaxation of detrusor smooth muscle via activation of G proteins and adenyl cyclase, increasing levels of cyclic adenosine monophosphate and increasing bladder storage capacity [4].
Mirabegron is the first of a new class of agents developed for the treatment of OAB. The efficacy of mirabegron 50 mg is similar to that of most approved antimuscarinics in reducing OAB symptoms. However, mirabegron has a better tolerability profile than antimuscarinics, with an incidence of dry mouth and constipation similar to that for placebo, and a significantly lower rate of dry mouth compared to all antimuscarinics [5]. Only solifenacin 10 mg has shown significantly superior efficacy in improving micturition and decreasing episodes of urgency urinary incontinence in comparison to mirabegron 50 mg [5].
In this issue of European Urology, Drake et al [6] report results for the BESIDE study, a randomised, double-blind, multicentre phase 3B trial evaluating the efficacy, safety, and tolerability of a combination of solifenacin 5 mg and mirabegron 50 mg compared to solifenacin 5 or 10 mg in OAB patients remaining incontinent after 4 wk of treatment with solifenacin 5 mg. At the end of the treatment it was observed that the combination therapy was significantly superior to solifenacin 5 mg, with meaningful improvements in daily incontinence, daily number of micturitions, and incontinence noted in a 3-d diary. However, the combination therapy was noninferior to solifenacin 10 mg for key secondary endpoints and superior to solifenacin 10 mg in improving daily micturitions. The authors conclude that adding mirabegron 50 mg to solifenacin 5 mg further improved OAB symptoms compared to solifenacin 5 or 10 mg, and it was well tolerated in OAB patients remaining incontinent after initial therapy with solifenacin 5 mg.
Combination therapy for lower urinary tract symptoms (LUTS) is not new. Medical management of men with moderate to severe LUTS due to benign prostatic hyperplasia with α-blockers and 5-α reductase inhibitors (5-ARIs) is effective not only in improving LUTS but also in reducing the relative risk of disease progression [7]. More recently, it was shown that a combination of solifenacin and tamsulosin was efficacious in improving symptoms in patients who did not respond initially to α-blocker therapy [8]. The aim of these combinations is to add different mechanisms of actions to achieve an improvement in patient quality of life, which should involve control of symptoms with the lowest rate of adverse events.
In the study by Drake et al, the incidence of treatment emergent adverse events (TEAEs) was lowest for solifenacin 5 mg (33.1%), highest for solifenacin 10 mg (39.4%), and 35.9% for the combination. The incidence of dry mouth, the most common TEAE of antimuscarinics, was lower for the combination (5.9%) than for solifenacin 10 mg (9.5%) and similar to solifenacin 5 mg (5.6%). A general mean rise of 1 mm Hg in systolic blood pressure was observed between the combination and solifenacin monotherapy at end of treatment, which is attributable to mirabegron. There were no significant differences in vital signs, including subpopulations stratified by hypertensive status and β-blocker use, nor were there notable cardiovascular changes. A recent systematic review addressing the cardiovascular safety of β3-adrenoceptor agonists for the treatment of patients with OAB found that the cardiovascular safety of mirabegron appears to be good and comparable to that of antimuscarinic agents. However, because data for patients with poorly controlled hypertension, arrhythmia, or cardiac heart failure are currently lacking, periodic blood pressure and heart rate measurements are recommended for patients with significant cardiovascular risk factors, such as coronary heart disease and cardiomyopathy, and those aged >80 yr [9].
The findings reported by Drake et al suggest that combination therapy of solifenacin 5 mg and mirabegron 50 mg may be an alternative to dose escalation of solifenacin in patients with insufficient response to solifenacin 5 mg.
OAB is a complex condition affecting different patients who may be treated with different pharmacotherapy options and exhibit different responses. Some patients may primarily respond very well to initial therapy, while others do not. Combination therapy of solifenacin and mirabegron may contribute in optimising efficacy with an acceptable tolerability profile in comparison to a higher antimuscarinic dose. This approach may provide greater patient satisfaction, contributing to higher adherence and persistence rates and yielding a better efficacy-tolerability balance.
Barbara Padilla-Fernandez has received travel grants from Astellas, Almirall, and GebroPharma. David Castro-Diaz has been an investigator for Astellas and Allergan and a speaker for Astellas, Allergan, Pfizer, Medtronic, and Neo-Medic.
Overactive bladder (OAB) is a highly prevalent syndrome associated with significant bother and impact on quality of life. The mainstay of pharmacotherapy for OAB has been based on antimuscarinic drugs. It has been shown that antimuscarinic agents are more effective than placebo in reducing symptoms and in improving health-related quality of life [1]. Nevertheless, adherence and persistence for antimuscarinic therapy are very low, with rates of only 12.0–39.4% after 12 mo reported [2]. Patients abandon treatment because of unrealistic expectations regarding drug efficacy and bothersome side effects such as dry mouth and constipation. These undesirable symptoms occur more frequently for higher antimuscarinic doses, although their severity is not dose-dependent [3].
The introduction of mirabegron, a β3-adrenoceptor agonist, offers an alternative option for OAB patients who do not respond to or tolerate antimuscarinic drugs because of its different mechanism of action. Stimulation of β3-adrenoceptors results in direct relaxation of detrusor smooth muscle via activation of G proteins and adenyl cyclase, increasing levels of cyclic adenosine monophosphate and increasing bladder storage capacity [4].
Mirabegron is the first of a new class of agents developed for the treatment of OAB. The efficacy of mirabegron 50 mg is similar to that of most approved antimuscarinics in reducing OAB symptoms. However, mirabegron has a better tolerability profile than antimuscarinics, with an incidence of dry mouth and constipation similar to that for placebo, and a significantly lower rate of dry mouth compared to all antimuscarinics [5]. Only solifenacin 10 mg has shown significantly superior efficacy in improving micturition and decreasing episodes of urgency urinary incontinence in comparison to mirabegron 50 mg [5].
In this issue of European Urology, Drake et al [6] report results for the BESIDE study, a randomised, double-blind, multicentre phase 3B trial evaluating the efficacy, safety, and tolerability of a combination of solifenacin 5 mg and mirabegron 50 mg compared to solifenacin 5 or 10 mg in OAB patients remaining incontinent after 4 wk of treatment with solifenacin 5 mg. At the end of the treatment it was observed that the combination therapy was significantly superior to solifenacin 5 mg, with meaningful improvements in daily incontinence, daily number of micturitions, and incontinence noted in a 3-d diary. However, the combination therapy was noninferior to solifenacin 10 mg for key secondary endpoints and superior to solifenacin 10 mg in improving daily micturitions. The authors conclude that adding mirabegron 50 mg to solifenacin 5 mg further improved OAB symptoms compared to solifenacin 5 or 10 mg, and it was well tolerated in OAB patients remaining incontinent after initial therapy with solifenacin 5 mg.
Combination therapy for lower urinary tract symptoms (LUTS) is not new. Medical management of men with moderate to severe LUTS due to benign prostatic hyperplasia with α-blockers and 5-α reductase inhibitors (5-ARIs) is effective not only in improving LUTS but also in reducing the relative risk of disease progression [7]. More recently, it was shown that a combination of solifenacin and tamsulosin was efficacious in improving symptoms in patients who did not respond initially to α-blocker therapy [8]. The aim of these combinations is to add different mechanisms of actions to achieve an improvement in patient quality of life, which should involve control of symptoms with the lowest rate of adverse events.
In the study by Drake et al, the incidence of treatment emergent adverse events (TEAEs) was lowest for solifenacin 5 mg (33.1%), highest for solifenacin 10 mg (39.4%), and 35.9% for the combination. The incidence of dry mouth, the most common TEAE of antimuscarinics, was lower for the combination (5.9%) than for solifenacin 10 mg (9.5%) and similar to solifenacin 5 mg (5.6%). A general mean rise of 1 mm Hg in systolic blood pressure was observed between the combination and solifenacin monotherapy at end of treatment, which is attributable to mirabegron. There were no significant differences in vital signs, including subpopulations stratified by hypertensive status and β-blocker use, nor were there notable cardiovascular changes. A recent systematic review addressing the cardiovascular safety of β3-adrenoceptor agonists for the treatment of patients with OAB found that the cardiovascular safety of mirabegron appears to be good and comparable to that of antimuscarinic agents. However, because data for patients with poorly controlled hypertension, arrhythmia, or cardiac heart failure are currently lacking, periodic blood pressure and heart rate measurements are recommended for patients with significant cardiovascular risk factors, such as coronary heart disease and cardiomyopathy, and those aged >80 yr [9].
The findings reported by Drake et al suggest that combination therapy of solifenacin 5 mg and mirabegron 50 mg may be an alternative to dose escalation of solifenacin in patients with insufficient response to solifenacin 5 mg.
OAB is a complex condition affecting different patients who may be treated with different pharmacotherapy options and exhibit different responses. Some patients may primarily respond very well to initial therapy, while others do not. Combination therapy of solifenacin and mirabegron may contribute in optimising efficacy with an acceptable tolerability profile in comparison to a higher antimuscarinic dose. This approach may provide greater patient satisfaction, contributing to higher adherence and persistence rates and yielding a better efficacy-tolerability balance.
Barbara Padilla-Fernandez has received travel grants from Astellas, Almirall, and GebroPharma. David Castro-Diaz has been an investigator for Astellas and Allergan and a speaker for Astellas, Allergan, Pfizer, Medtronic, and Neo-Medic.
Overactive bladder (OAB) is a highly prevalent syndrome associated with significant bother and impact on quality of life. The mainstay of pharmacotherapy for OAB has been based on antimuscarinic drugs. It has been shown that antimuscarinic agents are more effective than placebo in reducing symptoms and in improving health-related quality of life [1]. Nevertheless, adherence and persistence for antimuscarinic therapy are very low, with rates of only 12.0–39.4% after 12 mo reported [2]. Patients abandon treatment because of unrealistic expectations regarding drug efficacy and bothersome side effects such as dry mouth and constipation. These undesirable symptoms occur more frequently for higher antimuscarinic doses, although their severity is not dose-dependent [3].
The introduction of mirabegron, a β3-adrenoceptor agonist, offers an alternative option for OAB patients who do not respond to or tolerate antimuscarinic drugs because of its different mechanism of action. Stimulation of β3-adrenoceptors results in direct relaxation of detrusor smooth muscle via activation of G proteins and adenyl cyclase, increasing levels of cyclic adenosine monophosphate and increasing bladder storage capacity [4].
Mirabegron is the first of a new class of agents developed for the treatment of OAB. The efficacy of mirabegron 50 mg is similar to that of most approved antimuscarinics in reducing OAB symptoms. However, mirabegron has a better tolerability profile than antimuscarinics, with an incidence of dry mouth and constipation similar to that for placebo, and a significantly lower rate of dry mouth compared to all antimuscarinics [5]. Only solifenacin 10 mg has shown significantly superior efficacy in improving micturition and decreasing episodes of urgency urinary incontinence in comparison to mirabegron 50 mg [5].
In this issue of European Urology, Drake et al [6] report results for the BESIDE study, a randomised, double-blind, multicentre phase 3B trial evaluating the efficacy, safety, and tolerability of a combination of solifenacin 5 mg and mirabegron 50 mg compared to solifenacin 5 or 10 mg in OAB patients remaining incontinent after 4 wk of treatment with solifenacin 5 mg. At the end of the treatment it was observed that the combination therapy was significantly superior to solifenacin 5 mg, with meaningful improvements in daily incontinence, daily number of micturitions, and incontinence noted in a 3-d diary. However, the combination therapy was noninferior to solifenacin 10 mg for key secondary endpoints and superior to solifenacin 10 mg in improving daily micturitions. The authors conclude that adding mirabegron 50 mg to solifenacin 5 mg further improved OAB symptoms compared to solifenacin 5 or 10 mg, and it was well tolerated in OAB patients remaining incontinent after initial therapy with solifenacin 5 mg.
Combination therapy for lower urinary tract symptoms (LUTS) is not new. Medical management of men with moderate to severe LUTS due to benign prostatic hyperplasia with α-blockers and 5-α reductase inhibitors (5-ARIs) is effective not only in improving LUTS but also in reducing the relative risk of disease progression [7]. More recently, it was shown that a combination of solifenacin and tamsulosin was efficacious in improving symptoms in patients who did not respond initially to α-blocker therapy [8]. The aim of these combinations is to add different mechanisms of actions to achieve an improvement in patient quality of life, which should involve control of symptoms with the lowest rate of adverse events.
In the study by Drake et al, the incidence of treatment emergent adverse events (TEAEs) was lowest for solifenacin 5 mg (33.1%), highest for solifenacin 10 mg (39.4%), and 35.9% for the combination. The incidence of dry mouth, the most common TEAE of antimuscarinics, was lower for the combination (5.9%) than for solifenacin 10 mg (9.5%) and similar to solifenacin 5 mg (5.6%). A general mean rise of 1 mm Hg in systolic blood pressure was observed between the combination and solifenacin monotherapy at end of treatment, which is attributable to mirabegron. There were no significant differences in vital signs, including subpopulations stratified by hypertensive status and β-blocker use, nor were there notable cardiovascular changes. A recent systematic review addressing the cardiovascular safety of β3-adrenoceptor agonists for the treatment of patients with OAB found that the cardiovascular safety of mirabegron appears to be good and comparable to that of antimuscarinic agents. However, because data for patients with poorly controlled hypertension, arrhythmia, or cardiac heart failure are currently lacking, periodic blood pressure and heart rate measurements are recommended for patients with significant cardiovascular risk factors, such as coronary heart disease and cardiomyopathy, and those aged >80 yr [9].
The findings reported by Drake et al suggest that combination therapy of solifenacin 5 mg and mirabegron 50 mg may be an alternative to dose escalation of solifenacin in patients with insufficient response to solifenacin 5 mg.
OAB is a complex condition affecting different patients who may be treated with different pharmacotherapy options and exhibit different responses. Some patients may primarily respond very well to initial therapy, while others do not. Combination therapy of solifenacin and mirabegron may contribute in optimising efficacy with an acceptable tolerability profile in comparison to a higher antimuscarinic dose. This approach may provide greater patient satisfaction, contributing to higher adherence and persistence rates and yielding a better efficacy-tolerability balance.
Barbara Padilla-Fernandez has received travel grants from Astellas, Almirall, and GebroPharma. David Castro-Diaz has been an investigator for Astellas and Allergan and a speaker for Astellas, Allergan, Pfizer, Medtronic, and Neo-Medic.
Overactive bladder (OAB) is a highly prevalent syndrome associated with significant bother and impact on quality of life. The mainstay of pharmacotherapy for OAB has been based on antimuscarinic drugs. It has been shown that antimuscarinic agents are more effective than placebo in reducing symptoms and in improving health-related quality of life [1]. Nevertheless, adherence and persistence for antimuscarinic therapy are very low, with rates of only 12.0–39.4% after 12 mo reported [2]. Patients abandon treatment because of unrealistic expectations regarding drug efficacy and bothersome side effects such as dry mouth and constipation. These undesirable symptoms occur more frequently for higher antimuscarinic doses, although their severity is not dose-dependent [3].
The introduction of mirabegron, a β3-adrenoceptor agonist, offers an alternative option for OAB patients who do not respond to or tolerate antimuscarinic drugs because of its different mechanism of action. Stimulation of β3-adrenoceptors results in direct relaxation of detrusor smooth muscle via activation of G proteins and adenyl cyclase, increasing levels of cyclic adenosine monophosphate and increasing bladder storage capacity [4].
Mirabegron is the first of a new class of agents developed for the treatment of OAB. The efficacy of mirabegron 50 mg is similar to that of most approved antimuscarinics in reducing OAB symptoms. However, mirabegron has a better tolerability profile than antimuscarinics, with an incidence of dry mouth and constipation similar to that for placebo, and a significantly lower rate of dry mouth compared to all antimuscarinics [5]. Only solifenacin 10 mg has shown significantly superior efficacy in improving micturition and decreasing episodes of urgency urinary incontinence in comparison to mirabegron 50 mg [5].
In this issue of European Urology, Drake et al [6] report results for the BESIDE study, a randomised, double-blind, multicentre phase 3B trial evaluating the efficacy, safety, and tolerability of a combination of solifenacin 5 mg and mirabegron 50 mg compared to solifenacin 5 or 10 mg in OAB patients remaining incontinent after 4 wk of treatment with solifenacin 5 mg. At the end of the treatment it was observed that the combination therapy was significantly superior to solifenacin 5 mg, with meaningful improvements in daily incontinence, daily number of micturitions, and incontinence noted in a 3-d diary. However, the combination therapy was noninferior to solifenacin 10 mg for key secondary endpoints and superior to solifenacin 10 mg in improving daily micturitions. The authors conclude that adding mirabegron 50 mg to solifenacin 5 mg further improved OAB symptoms compared to solifenacin 5 or 10 mg, and it was well tolerated in OAB patients remaining incontinent after initial therapy with solifenacin 5 mg.
Combination therapy for lower urinary tract symptoms (LUTS) is not new. Medical management of men with moderate to severe LUTS due to benign prostatic hyperplasia with α-blockers and 5-α reductase inhibitors (5-ARIs) is effective not only in improving LUTS but also in reducing the relative risk of disease progression [7]. More recently, it was shown that a combination of solifenacin and tamsulosin was efficacious in improving symptoms in patients who did not respond initially to α-blocker therapy [8]. The aim of these combinations is to add different mechanisms of actions to achieve an improvement in patient quality of life, which should involve control of symptoms with the lowest rate of adverse events.
In the study by Drake et al, the incidence of treatment emergent adverse events (TEAEs) was lowest for solifenacin 5 mg (33.1%), highest for solifenacin 10 mg (39.4%), and 35.9% for the combination. The incidence of dry mouth, the most common TEAE of antimuscarinics, was lower for the combination (5.9%) than for solifenacin 10 mg (9.5%) and similar to solifenacin 5 mg (5.6%). A general mean rise of 1 mm Hg in systolic blood pressure was observed between the combination and solifenacin monotherapy at end of treatment, which is attributable to mirabegron. There were no significant differences in vital signs, including subpopulations stratified by hypertensive status and β-blocker use, nor were there notable cardiovascular changes. A recent systematic review addressing the cardiovascular safety of β3-adrenoceptor agonists for the treatment of patients with OAB found that the cardiovascular safety of mirabegron appears to be good and comparable to that of antimuscarinic agents. However, because data for patients with poorly controlled hypertension, arrhythmia, or cardiac heart failure are currently lacking, periodic blood pressure and heart rate measurements are recommended for patients with significant cardiovascular risk factors, such as coronary heart disease and cardiomyopathy, and those aged >80 yr [9].
The findings reported by Drake et al suggest that combination therapy of solifenacin 5 mg and mirabegron 50 mg may be an alternative to dose escalation of solifenacin in patients with insufficient response to solifenacin 5 mg.
OAB is a complex condition affecting different patients who may be treated with different pharmacotherapy options and exhibit different responses. Some patients may primarily respond very well to initial therapy, while others do not. Combination therapy of solifenacin and mirabegron may contribute in optimising efficacy with an acceptable tolerability profile in comparison to a higher antimuscarinic dose. This approach may provide greater patient satisfaction, contributing to higher adherence and persistence rates and yielding a better efficacy-tolerability balance.
Barbara Padilla-Fernandez has received travel grants from Astellas, Almirall, and GebroPharma. David Castro-Diaz has been an investigator for Astellas and Allergan and a speaker for Astellas, Allergan, Pfizer, Medtronic, and Neo-Medic.
Overactive bladder (OAB) is a highly prevalent syndrome associated with significant bother and impact on quality of life. The mainstay of pharmacotherapy for OAB has been based on antimuscarinic drugs. It has been shown that antimuscarinic agents are more effective than placebo in reducing symptoms and in improving health-related quality of life [1]. Nevertheless, adherence and persistence for antimuscarinic therapy are very low, with rates of only 12.0–39.4% after 12 mo reported [2]. Patients abandon treatment because of unrealistic expectations regarding drug efficacy and bothersome side effects such as dry mouth and constipation. These undesirable symptoms occur more frequently for higher antimuscarinic doses, although their severity is not dose-dependent [3].
The introduction of mirabegron, a β3-adrenoceptor agonist, offers an alternative option for OAB patients who do not respond to or tolerate antimuscarinic drugs because of its different mechanism of action. Stimulation of β3-adrenoceptors results in direct relaxation of detrusor smooth muscle via activation of G proteins and adenyl cyclase, increasing levels of cyclic adenosine monophosphate and increasing bladder storage capacity [4].
Mirabegron is the first of a new class of agents developed for the treatment of OAB. The efficacy of mirabegron 50 mg is similar to that of most approved antimuscarinics in reducing OAB symptoms. However, mirabegron has a better tolerability profile than antimuscarinics, with an incidence of dry mouth and constipation similar to that for placebo, and a significantly lower rate of dry mouth compared to all antimuscarinics [5]. Only solifenacin 10 mg has shown significantly superior efficacy in improving micturition and decreasing episodes of urgency urinary incontinence in comparison to mirabegron 50 mg [5].
In this issue of European Urology, Drake et al [6] report results for the BESIDE study, a randomised, double-blind, multicentre phase 3B trial evaluating the efficacy, safety, and tolerability of a combination of solifenacin 5 mg and mirabegron 50 mg compared to solifenacin 5 or 10 mg in OAB patients remaining incontinent after 4 wk of treatment with solifenacin 5 mg. At the end of the treatment it was observed that the combination therapy was significantly superior to solifenacin 5 mg, with meaningful improvements in daily incontinence, daily number of micturitions, and incontinence noted in a 3-d diary. However, the combination therapy was noninferior to solifenacin 10 mg for key secondary endpoints and superior to solifenacin 10 mg in improving daily micturitions. The authors conclude that adding mirabegron 50 mg to solifenacin 5 mg further improved OAB symptoms compared to solifenacin 5 or 10 mg, and it was well tolerated in OAB patients remaining incontinent after initial therapy with solifenacin 5 mg.
Combination therapy for lower urinary tract symptoms (LUTS) is not new. Medical management of men with moderate to severe LUTS due to benign prostatic hyperplasia with α-blockers and 5-α reductase inhibitors (5-ARIs) is effective not only in improving LUTS but also in reducing the relative risk of disease progression [7]. More recently, it was shown that a combination of solifenacin and tamsulosin was efficacious in improving symptoms in patients who did not respond initially to α-blocker therapy [8]. The aim of these combinations is to add different mechanisms of actions to achieve an improvement in patient quality of life, which should involve control of symptoms with the lowest rate of adverse events.
In the study by Drake et al, the incidence of treatment emergent adverse events (TEAEs) was lowest for solifenacin 5 mg (33.1%), highest for solifenacin 10 mg (39.4%), and 35.9% for the combination. The incidence of dry mouth, the most common TEAE of antimuscarinics, was lower for the combination (5.9%) than for solifenacin 10 mg (9.5%) and similar to solifenacin 5 mg (5.6%). A general mean rise of 1 mm Hg in systolic blood pressure was observed between the combination and solifenacin monotherapy at end of treatment, which is attributable to mirabegron. There were no significant differences in vital signs, including subpopulations stratified by hypertensive status and β-blocker use, nor were there notable cardiovascular changes. A recent systematic review addressing the cardiovascular safety of β3-adrenoceptor agonists for the treatment of patients with OAB found that the cardiovascular safety of mirabegron appears to be good and comparable to that of antimuscarinic agents. However, because data for patients with poorly controlled hypertension, arrhythmia, or cardiac heart failure are currently lacking, periodic blood pressure and heart rate measurements are recommended for patients with significant cardiovascular risk factors, such as coronary heart disease and cardiomyopathy, and those aged >80 yr [9].
The findings reported by Drake et al suggest that combination therapy of solifenacin 5 mg and mirabegron 50 mg may be an alternative to dose escalation of solifenacin in patients with insufficient response to solifenacin 5 mg.
OAB is a complex condition affecting different patients who may be treated with different pharmacotherapy options and exhibit different responses. Some patients may primarily respond very well to initial therapy, while others do not. Combination therapy of solifenacin and mirabegron may contribute in optimising efficacy with an acceptable tolerability profile in comparison to a higher antimuscarinic dose. This approach may provide greater patient satisfaction, contributing to higher adherence and persistence rates and yielding a better efficacy-tolerability balance.
Barbara Padilla-Fernandez has received travel grants from Astellas, Almirall, and GebroPharma. David Castro-Diaz has been an investigator for Astellas and Allergan and a speaker for Astellas, Allergan, Pfizer, Medtronic, and Neo-Medic.
Overactive bladder (OAB) is a highly prevalent syndrome associated with significant bother and impact on quality of life. The mainstay of pharmacotherapy for OAB has been based on antimuscarinic drugs. It has been shown that antimuscarinic agents are more effective than placebo in reducing symptoms and in improving health-related quality of life [1]. Nevertheless, adherence and persistence for antimuscarinic therapy are very low, with rates of only 12.0–39.4% after 12 mo reported [2]. Patients abandon treatment because of unrealistic expectations regarding drug efficacy and bothersome side effects such as dry mouth and constipation. These undesirable symptoms occur more frequently for higher antimuscarinic doses, although their severity is not dose-dependent [3].
The introduction of mirabegron, a β3-adrenoceptor agonist, offers an alternative option for OAB patients who do not respond to or tolerate antimuscarinic drugs because of its different mechanism of action. Stimulation of β3-adrenoceptors results in direct relaxation of detrusor smooth muscle via activation of G proteins and adenyl cyclase, increasing levels of cyclic adenosine monophosphate and increasing bladder storage capacity [4].
Mirabegron is the first of a new class of agents developed for the treatment of OAB. The efficacy of mirabegron 50 mg is similar to that of most approved antimuscarinics in reducing OAB symptoms. However, mirabegron has a better tolerability profile than antimuscarinics, with an incidence of dry mouth and constipation similar to that for placebo, and a significantly lower rate of dry mouth compared to all antimuscarinics [5]. Only solifenacin 10 mg has shown significantly superior efficacy in improving micturition and decreasing episodes of urgency urinary incontinence in comparison to mirabegron 50 mg [5].
In this issue of European Urology, Drake et al [6] report results for the BESIDE study, a randomised, double-blind, multicentre phase 3B trial evaluating the efficacy, safety, and tolerability of a combination of solifenacin 5 mg and mirabegron 50 mg compared to solifenacin 5 or 10 mg in OAB patients remaining incontinent after 4 wk of treatment with solifenacin 5 mg. At the end of the treatment it was observed that the combination therapy was significantly superior to solifenacin 5 mg, with meaningful improvements in daily incontinence, daily number of micturitions, and incontinence noted in a 3-d diary. However, the combination therapy was noninferior to solifenacin 10 mg for key secondary endpoints and superior to solifenacin 10 mg in improving daily micturitions. The authors conclude that adding mirabegron 50 mg to solifenacin 5 mg further improved OAB symptoms compared to solifenacin 5 or 10 mg, and it was well tolerated in OAB patients remaining incontinent after initial therapy with solifenacin 5 mg.
Combination therapy for lower urinary tract symptoms (LUTS) is not new. Medical management of men with moderate to severe LUTS due to benign prostatic hyperplasia with α-blockers and 5-α reductase inhibitors (5-ARIs) is effective not only in improving LUTS but also in reducing the relative risk of disease progression [7]. More recently, it was shown that a combination of solifenacin and tamsulosin was efficacious in improving symptoms in patients who did not respond initially to α-blocker therapy [8]. The aim of these combinations is to add different mechanisms of actions to achieve an improvement in patient quality of life, which should involve control of symptoms with the lowest rate of adverse events.
In the study by Drake et al, the incidence of treatment emergent adverse events (TEAEs) was lowest for solifenacin 5 mg (33.1%), highest for solifenacin 10 mg (39.4%), and 35.9% for the combination. The incidence of dry mouth, the most common TEAE of antimuscarinics, was lower for the combination (5.9%) than for solifenacin 10 mg (9.5%) and similar to solifenacin 5 mg (5.6%). A general mean rise of 1 mm Hg in systolic blood pressure was observed between the combination and solifenacin monotherapy at end of treatment, which is attributable to mirabegron. There were no significant differences in vital signs, including subpopulations stratified by hypertensive status and β-blocker use, nor were there notable cardiovascular changes. A recent systematic review addressing the cardiovascular safety of β3-adrenoceptor agonists for the treatment of patients with OAB found that the cardiovascular safety of mirabegron appears to be good and comparable to that of antimuscarinic agents. However, because data for patients with poorly controlled hypertension, arrhythmia, or cardiac heart failure are currently lacking, periodic blood pressure and heart rate measurements are recommended for patients with significant cardiovascular risk factors, such as coronary heart disease and cardiomyopathy, and those aged >80 yr [9].
The findings reported by Drake et al suggest that combination therapy of solifenacin 5 mg and mirabegron 50 mg may be an alternative to dose escalation of solifenacin in patients with insufficient response to solifenacin 5 mg.
OAB is a complex condition affecting different patients who may be treated with different pharmacotherapy options and exhibit different responses. Some patients may primarily respond very well to initial therapy, while others do not. Combination therapy of solifenacin and mirabegron may contribute in optimising efficacy with an acceptable tolerability profile in comparison to a higher antimuscarinic dose. This approach may provide greater patient satisfaction, contributing to higher adherence and persistence rates and yielding a better efficacy-tolerability balance.
Barbara Padilla-Fernandez has received travel grants from Astellas, Almirall, and GebroPharma. David Castro-Diaz has been an investigator for Astellas and Allergan and a speaker for Astellas, Allergan, Pfizer, Medtronic, and Neo-Medic.
Overactive bladder (OAB) is a highly prevalent syndrome associated with significant bother and impact on quality of life. The mainstay of pharmacotherapy for OAB has been based on antimuscarinic drugs. It has been shown that antimuscarinic agents are more effective than placebo in reducing symptoms and in improving health-related quality of life [1]. Nevertheless, adherence and persistence for antimuscarinic therapy are very low, with rates of only 12.0–39.4% after 12 mo reported [2]. Patients abandon treatment because of unrealistic expectations regarding drug efficacy and bothersome side effects such as dry mouth and constipation. These undesirable symptoms occur more frequently for higher antimuscarinic doses, although their severity is not dose-dependent [3].
The introduction of mirabegron, a β3-adrenoceptor agonist, offers an alternative option for OAB patients who do not respond to or tolerate antimuscarinic drugs because of its different mechanism of action. Stimulation of β3-adrenoceptors results in direct relaxation of detrusor smooth muscle via activation of G proteins and adenyl cyclase, increasing levels of cyclic adenosine monophosphate and increasing bladder storage capacity [4].
Mirabegron is the first of a new class of agents developed for the treatment of OAB. The efficacy of mirabegron 50 mg is similar to that of most approved antimuscarinics in reducing OAB symptoms. However, mirabegron has a better tolerability profile than antimuscarinics, with an incidence of dry mouth and constipation similar to that for placebo, and a significantly lower rate of dry mouth compared to all antimuscarinics [5]. Only solifenacin 10 mg has shown significantly superior efficacy in improving micturition and decreasing episodes of urgency urinary incontinence in comparison to mirabegron 50 mg [5].
In this issue of European Urology, Drake et al [6] report results for the BESIDE study, a randomised, double-blind, multicentre phase 3B trial evaluating the efficacy, safety, and tolerability of a combination of solifenacin 5 mg and mirabegron 50 mg compared to solifenacin 5 or 10 mg in OAB patients remaining incontinent after 4 wk of treatment with solifenacin 5 mg. At the end of the treatment it was observed that the combination therapy was significantly superior to solifenacin 5 mg, with meaningful improvements in daily incontinence, daily number of micturitions, and incontinence noted in a 3-d diary. However, the combination therapy was noninferior to solifenacin 10 mg for key secondary endpoints and superior to solifenacin 10 mg in improving daily micturitions. The authors conclude that adding mirabegron 50 mg to solifenacin 5 mg further improved OAB symptoms compared to solifenacin 5 or 10 mg, and it was well tolerated in OAB patients remaining incontinent after initial therapy with solifenacin 5 mg.
Combination therapy for lower urinary tract symptoms (LUTS) is not new. Medical management of men with moderate to severe LUTS due to benign prostatic hyperplasia with α-blockers and 5-α reductase inhibitors (5-ARIs) is effective not only in improving LUTS but also in reducing the relative risk of disease progression [7]. More recently, it was shown that a combination of solifenacin and tamsulosin was efficacious in improving symptoms in patients who did not respond initially to α-blocker therapy [8]. The aim of these combinations is to add different mechanisms of actions to achieve an improvement in patient quality of life, which should involve control of symptoms with the lowest rate of adverse events.
In the study by Drake et al, the incidence of treatment emergent adverse events (TEAEs) was lowest for solifenacin 5 mg (33.1%), highest for solifenacin 10 mg (39.4%), and 35.9% for the combination. The incidence of dry mouth, the most common TEAE of antimuscarinics, was lower for the combination (5.9%) than for solifenacin 10 mg (9.5%) and similar to solifenacin 5 mg (5.6%). A general mean rise of 1 mm Hg in systolic blood pressure was observed between the combination and solifenacin monotherapy at end of treatment, which is attributable to mirabegron. There were no significant differences in vital signs, including subpopulations stratified by hypertensive status and β-blocker use, nor were there notable cardiovascular changes. A recent systematic review addressing the cardiovascular safety of β3-adrenoceptor agonists for the treatment of patients with OAB found that the cardiovascular safety of mirabegron appears to be good and comparable to that of antimuscarinic agents. However, because data for patients with poorly controlled hypertension, arrhythmia, or cardiac heart failure are currently lacking, periodic blood pressure and heart rate measurements are recommended for patients with significant cardiovascular risk factors, such as coronary heart disease and cardiomyopathy, and those aged >80 yr [9].
The findings reported by Drake et al suggest that combination therapy of solifenacin 5 mg and mirabegron 50 mg may be an alternative to dose escalation of solifenacin in patients with insufficient response to solifenacin 5 mg.
OAB is a complex condition affecting different patients who may be treated with different pharmacotherapy options and exhibit different responses. Some patients may primarily respond very well to initial therapy, while others do not. Combination therapy of solifenacin and mirabegron may contribute in optimising efficacy with an acceptable tolerability profile in comparison to a higher antimuscarinic dose. This approach may provide greater patient satisfaction, contributing to higher adherence and persistence rates and yielding a better efficacy-tolerability balance.
Barbara Padilla-Fernandez has received travel grants from Astellas, Almirall, and GebroPharma. David Castro-Diaz has been an investigator for Astellas and Allergan and a speaker for Astellas, Allergan, Pfizer, Medtronic, and Neo-Medic.
Overactive bladder (OAB) is a highly prevalent syndrome associated with significant bother and impact on quality of life. The mainstay of pharmacotherapy for OAB has been based on antimuscarinic drugs. It has been shown that antimuscarinic agents are more effective than placebo in reducing symptoms and in improving health-related quality of life [1]. Nevertheless, adherence and persistence for antimuscarinic therapy are very low, with rates of only 12.0–39.4% after 12 mo reported [2]. Patients abandon treatment because of unrealistic expectations regarding drug efficacy and bothersome side effects such as dry mouth and constipation. These undesirable symptoms occur more frequently for higher antimuscarinic doses, although their severity is not dose-dependent [3].
The introduction of mirabegron, a β3-adrenoceptor agonist, offers an alternative option for OAB patients who do not respond to or tolerate antimuscarinic drugs because of its different mechanism of action. Stimulation of β3-adrenoceptors results in direct relaxation of detrusor smooth muscle via activation of G proteins and adenyl cyclase, increasing levels of cyclic adenosine monophosphate and increasing bladder storage capacity [4].
Mirabegron is the first of a new class of agents developed for the treatment of OAB. The efficacy of mirabegron 50 mg is similar to that of most approved antimuscarinics in reducing OAB symptoms. However, mirabegron has a better tolerability profile than antimuscarinics, with an incidence of dry mouth and constipation similar to that for placebo, and a significantly lower rate of dry mouth compared to all antimuscarinics [5]. Only solifenacin 10 mg has shown significantly superior efficacy in improving micturition and decreasing episodes of urgency urinary incontinence in comparison to mirabegron 50 mg [5].
In this issue of European Urology, Drake et al [6] report results for the BESIDE study, a randomised, double-blind, multicentre phase 3B trial evaluating the efficacy, safety, and tolerability of a combination of solifenacin 5 mg and mirabegron 50 mg compared to solifenacin 5 or 10 mg in OAB patients remaining incontinent after 4 wk of treatment with solifenacin 5 mg. At the end of the treatment it was observed that the combination therapy was significantly superior to solifenacin 5 mg, with meaningful improvements in daily incontinence, daily number of micturitions, and incontinence noted in a 3-d diary. However, the combination therapy was noninferior to solifenacin 10 mg for key secondary endpoints and superior to solifenacin 10 mg in improving daily micturitions. The authors conclude that adding mirabegron 50 mg to solifenacin 5 mg further improved OAB symptoms compared to solifenacin 5 or 10 mg, and it was well tolerated in OAB patients remaining incontinent after initial therapy with solifenacin 5 mg.
Combination therapy for lower urinary tract symptoms (LUTS) is not new. Medical management of men with moderate to severe LUTS due to benign prostatic hyperplasia with α-blockers and 5-α reductase inhibitors (5-ARIs) is effective not only in improving LUTS but also in reducing the relative risk of disease progression [7]. More recently, it was shown that a combination of solifenacin and tamsulosin was efficacious in improving symptoms in patients who did not respond initially to α-blocker therapy [8]. The aim of these combinations is to add different mechanisms of actions to achieve an improvement in patient quality of life, which should involve control of symptoms with the lowest rate of adverse events.
In the study by Drake et al, the incidence of treatment emergent adverse events (TEAEs) was lowest for solifenacin 5 mg (33.1%), highest for solifenacin 10 mg (39.4%), and 35.9% for the combination. The incidence of dry mouth, the most common TEAE of antimuscarinics, was lower for the combination (5.9%) than for solifenacin 10 mg (9.5%) and similar to solifenacin 5 mg (5.6%). A general mean rise of 1 mm Hg in systolic blood pressure was observed between the combination and solifenacin monotherapy at end of treatment, which is attributable to mirabegron. There were no significant differences in vital signs, including subpopulations stratified by hypertensive status and β-blocker use, nor were there notable cardiovascular changes. A recent systematic review addressing the cardiovascular safety of β3-adrenoceptor agonists for the treatment of patients with OAB found that the cardiovascular safety of mirabegron appears to be good and comparable to that of antimuscarinic agents. However, because data for patients with poorly controlled hypertension, arrhythmia, or cardiac heart failure are currently lacking, periodic blood pressure and heart rate measurements are recommended for patients with significant cardiovascular risk factors, such as coronary heart disease and cardiomyopathy, and those aged >80 yr [9].
The findings reported by Drake et al suggest that combination therapy of solifenacin 5 mg and mirabegron 50 mg may be an alternative to dose escalation of solifenacin in patients with insufficient response to solifenacin 5 mg.
OAB is a complex condition affecting different patients who may be treated with different pharmacotherapy options and exhibit different responses. Some patients may primarily respond very well to initial therapy, while others do not. Combination therapy of solifenacin and mirabegron may contribute in optimising efficacy with an acceptable tolerability profile in comparison to a higher antimuscarinic dose. This approach may provide greater patient satisfaction, contributing to higher adherence and persistence rates and yielding a better efficacy-tolerability balance.
Barbara Padilla-Fernandez has received travel grants from Astellas, Almirall, and GebroPharma. David Castro-Diaz has been an investigator for Astellas and Allergan and a speaker for Astellas, Allergan, Pfizer, Medtronic, and Neo-Medic.
Overactive bladder (OAB) is a highly prevalent syndrome associated with significant bother and impact on quality of life. The mainstay of pharmacotherapy for OAB has been based on antimuscarinic drugs. It has been shown that antimuscarinic agents are more effective than placebo in reducing symptoms and in improving health-related quality of life [1]. Nevertheless, adherence and persistence for antimuscarinic therapy are very low, with rates of only 12.0–39.4% after 12 mo reported [2]. Patients abandon treatment because of unrealistic expectations regarding drug efficacy and bothersome side effects such as dry mouth and constipation. These undesirable symptoms occur more frequently for higher antimuscarinic doses, although their severity is not dose-dependent [3].
The introduction of mirabegron, a β3-adrenoceptor agonist, offers an alternative option for OAB patients who do not respond to or tolerate antimuscarinic drugs because of its different mechanism of action. Stimulation of β3-adrenoceptors results in direct relaxation of detrusor smooth muscle via activation of G proteins and adenyl cyclase, increasing levels of cyclic adenosine monophosphate and increasing bladder storage capacity [4].
Mirabegron is the first of a new class of agents developed for the treatment of OAB. The efficacy of mirabegron 50 mg is similar to that of most approved antimuscarinics in reducing OAB symptoms. However, mirabegron has a better tolerability profile than antimuscarinics, with an incidence of dry mouth and constipation similar to that for placebo, and a significantly lower rate of dry mouth compared to all antimuscarinics [5]. Only solifenacin 10 mg has shown significantly superior efficacy in improving micturition and decreasing episodes of urgency urinary incontinence in comparison to mirabegron 50 mg [5].
In this issue of European Urology, Drake et al [6] report results for the BESIDE study, a randomised, double-blind, multicentre phase 3B trial evaluating the efficacy, safety, and tolerability of a combination of solifenacin 5 mg and mirabegron 50 mg compared to solifenacin 5 or 10 mg in OAB patients remaining incontinent after 4 wk of treatment with solifenacin 5 mg. At the end of the treatment it was observed that the combination therapy was significantly superior to solifenacin 5 mg, with meaningful improvements in daily incontinence, daily number of micturitions, and incontinence noted in a 3-d diary. However, the combination therapy was noninferior to solifenacin 10 mg for key secondary endpoints and superior to solifenacin 10 mg in improving daily micturitions. The authors conclude that adding mirabegron 50 mg to solifenacin 5 mg further improved OAB symptoms compared to solifenacin 5 or 10 mg, and it was well tolerated in OAB patients remaining incontinent after initial therapy with solifenacin 5 mg.
Combination therapy for lower urinary tract symptoms (LUTS) is not new. Medical management of men with moderate to severe LUTS due to benign prostatic hyperplasia with α-blockers and 5-α reductase inhibitors (5-ARIs) is effective not only in improving LUTS but also in reducing the relative risk of disease progression [7]. More recently, it was shown that a combination of solifenacin and tamsulosin was efficacious in improving symptoms in patients who did not respond initially to α-blocker therapy [8]. The aim of these combinations is to add different mechanisms of actions to achieve an improvement in patient quality of life, which should involve control of symptoms with the lowest rate of adverse events.
In the study by Drake et al, the incidence of treatment emergent adverse events (TEAEs) was lowest for solifenacin 5 mg (33.1%), highest for solifenacin 10 mg (39.4%), and 35.9% for the combination. The incidence of dry mouth, the most common TEAE of antimuscarinics, was lower for the combination (5.9%) than for solifenacin 10 mg (9.5%) and similar to solifenacin 5 mg (5.6%). A general mean rise of 1 mm Hg in systolic blood pressure was observed between the combination and solifenacin monotherapy at end of treatment, which is attributable to mirabegron. There were no significant differences in vital signs, including subpopulations stratified by hypertensive status and β-blocker use, nor were there notable cardiovascular changes. A recent systematic review addressing the cardiovascular safety of β3-adrenoceptor agonists for the treatment of patients with OAB found that the cardiovascular safety of mirabegron appears to be good and comparable to that of antimuscarinic agents. However, because data for patients with poorly controlled hypertension, arrhythmia, or cardiac heart failure are currently lacking, periodic blood pressure and heart rate measurements are recommended for patients with significant cardiovascular risk factors, such as coronary heart disease and cardiomyopathy, and those aged >80 yr [9].
The findings reported by Drake et al suggest that combination therapy of solifenacin 5 mg and mirabegron 50 mg may be an alternative to dose escalation of solifenacin in patients with insufficient response to solifenacin 5 mg.
OAB is a complex condition affecting different patients who may be treated with different pharmacotherapy options and exhibit different responses. Some patients may primarily respond very well to initial therapy, while others do not. Combination therapy of solifenacin and mirabegron may contribute in optimising efficacy with an acceptable tolerability profile in comparison to a higher antimuscarinic dose. This approach may provide greater patient satisfaction, contributing to higher adherence and persistence rates and yielding a better efficacy-tolerability balance.
Barbara Padilla-Fernandez has received travel grants from Astellas, Almirall, and GebroPharma. David Castro-Diaz has been an investigator for Astellas and Allergan and a speaker for Astellas, Allergan, Pfizer, Medtronic, and Neo-Medic.
Overactive bladder (OAB) is a highly prevalent syndrome associated with significant bother and impact on quality of life. The mainstay of pharmacotherapy for OAB has been based on antimuscarinic drugs. It has been shown that antimuscarinic agents are more effective than placebo in reducing symptoms and in improving health-related quality of life [1]. Nevertheless, adherence and persistence for antimuscarinic therapy are very low, with rates of only 12.0–39.4% after 12 mo reported [2]. Patients abandon treatment because of unrealistic expectations regarding drug efficacy and bothersome side effects such as dry mouth and constipation. These undesirable symptoms occur more frequently for higher antimuscarinic doses, although their severity is not dose-dependent [3].
The introduction of mirabegron, a β3-adrenoceptor agonist, offers an alternative option for OAB patients who do not respond to or tolerate antimuscarinic drugs because of its different mechanism of action. Stimulation of β3-adrenoceptors results in direct relaxation of detrusor smooth muscle via activation of G proteins and adenyl cyclase, increasing levels of cyclic adenosine monophosphate and increasing bladder storage capacity [4].
Mirabegron is the first of a new class of agents developed for the treatment of OAB. The efficacy of mirabegron 50 mg is similar to that of most approved antimuscarinics in reducing OAB symptoms. However, mirabegron has a better tolerability profile than antimuscarinics, with an incidence of dry mouth and constipation similar to that for placebo, and a significantly lower rate of dry mouth compared to all antimuscarinics [5]. Only solifenacin 10 mg has shown significantly superior efficacy in improving micturition and decreasing episodes of urgency urinary incontinence in comparison to mirabegron 50 mg [5].
In this issue of European Urology, Drake et al [6] report results for the BESIDE study, a randomised, double-blind, multicentre phase 3B trial evaluating the efficacy, safety, and tolerability of a combination of solifenacin 5 mg and mirabegron 50 mg compared to solifenacin 5 or 10 mg in OAB patients remaining incontinent after 4 wk of treatment with solifenacin 5 mg. At the end of the treatment it was observed that the combination therapy was significantly superior to solifenacin 5 mg, with meaningful improvements in daily incontinence, daily number of micturitions, and incontinence noted in a 3-d diary. However, the combination therapy was noninferior to solifenacin 10 mg for key secondary endpoints and superior to solifenacin 10 mg in improving daily micturitions. The authors conclude that adding mirabegron 50 mg to solifenacin 5 mg further improved OAB symptoms compared to solifenacin 5 or 10 mg, and it was well tolerated in OAB patients remaining incontinent after initial therapy with solifenacin 5 mg.
Combination therapy for lower urinary tract symptoms (LUTS) is not new. Medical management of men with moderate to severe LUTS due to benign prostatic hyperplasia with α-blockers and 5-α reductase inhibitors (5-ARIs) is effective not only in improving LUTS but also in reducing the relative risk of disease progression [7]. More recently, it was shown that a combination of solifenacin and tamsulosin was efficacious in improving symptoms in patients who did not respond initially to α-blocker therapy [8]. The aim of these combinations is to add different mechanisms of actions to achieve an improvement in patient quality of life, which should involve control of symptoms with the lowest rate of adverse events.
In the study by Drake et al, the incidence of treatment emergent adverse events (TEAEs) was lowest for solifenacin 5 mg (33.1%), highest for solifenacin 10 mg (39.4%), and 35.9% for the combination. The incidence of dry mouth, the most common TEAE of antimuscarinics, was lower for the combination (5.9%) than for solifenacin 10 mg (9.5%) and similar to solifenacin 5 mg (5.6%). A general mean rise of 1 mm Hg in systolic blood pressure was observed between the combination and solifenacin monotherapy at end of treatment, which is attributable to mirabegron. There were no significant differences in vital signs, including subpopulations stratified by hypertensive status and β-blocker use, nor were there notable cardiovascular changes. A recent systematic review addressing the cardiovascular safety of β3-adrenoceptor agonists for the treatment of patients with OAB found that the cardiovascular safety of mirabegron appears to be good and comparable to that of antimuscarinic agents. However, because data for patients with poorly controlled hypertension, arrhythmia, or cardiac heart failure are currently lacking, periodic blood pressure and heart rate measurements are recommended for patients with significant cardiovascular risk factors, such as coronary heart disease and cardiomyopathy, and those aged >80 yr [9].
The findings reported by Drake et al suggest that combination therapy of solifenacin 5 mg and mirabegron 50 mg may be an alternative to dose escalation of solifenacin in patients with insufficient response to solifenacin 5 mg.
OAB is a complex condition affecting different patients who may be treated with different pharmacotherapy options and exhibit different responses. Some patients may primarily respond very well to initial therapy, while others do not. Combination therapy of solifenacin and mirabegron may contribute in optimising efficacy with an acceptable tolerability profile in comparison to a higher antimuscarinic dose. This approach may provide greater patient satisfaction, contributing to higher adherence and persistence rates and yielding a better efficacy-tolerability balance.
Barbara Padilla-Fernandez has received travel grants from Astellas, Almirall, and GebroPharma. David Castro-Diaz has been an investigator for Astellas and Allergan and a speaker for Astellas, Allergan, Pfizer, Medtronic, and Neo-Medic.
Overactive bladder (OAB) is a highly prevalent syndrome associated with significant bother and impact on quality of life. The mainstay of pharmacotherapy for OAB has been based on antimuscarinic drugs. It has been shown that antimuscarinic agents are more effective than placebo in reducing symptoms and in improving health-related quality of life [1]. Nevertheless, adherence and persistence for antimuscarinic therapy are very low, with rates of only 12.0–39.4% after 12 mo reported [2]. Patients abandon treatment because of unrealistic expectations regarding drug efficacy and bothersome side effects such as dry mouth and constipation. These undesirable symptoms occur more frequently for higher antimuscarinic doses, although their severity is not dose-dependent [3].
The introduction of mirabegron, a β3-adrenoceptor agonist, offers an alternative option for OAB patients who do not respond to or tolerate antimuscarinic drugs because of its different mechanism of action. Stimulation of β3-adrenoceptors results in direct relaxation of detrusor smooth muscle via activation of G proteins and adenyl cyclase, increasing levels of cyclic adenosine monophosphate and increasing bladder storage capacity [4].
Mirabegron is the first of a new class of agents developed for the treatment of OAB. The efficacy of mirabegron 50 mg is similar to that of most approved antimuscarinics in reducing OAB symptoms. However, mirabegron has a better tolerability profile than antimuscarinics, with an incidence of dry mouth and constipation similar to that for placebo, and a significantly lower rate of dry mouth compared to all antimuscarinics [5]. Only solifenacin 10 mg has shown significantly superior efficacy in improving micturition and decreasing episodes of urgency urinary incontinence in comparison to mirabegron 50 mg [5].
In this issue of European Urology, Drake et al [6] report results for the BESIDE study, a randomised, double-blind, multicentre phase 3B trial evaluating the efficacy, safety, and tolerability of a combination of solifenacin 5 mg and mirabegron 50 mg compared to solifenacin 5 or 10 mg in OAB patients remaining incontinent after 4 wk of treatment with solifenacin 5 mg. At the end of the treatment it was observed that the combination therapy was significantly superior to solifenacin 5 mg, with meaningful improvements in daily incontinence, daily number of micturitions, and incontinence noted in a 3-d diary. However, the combination therapy was noninferior to solifenacin 10 mg for key secondary endpoints and superior to solifenacin 10 mg in improving daily micturitions. The authors conclude that adding mirabegron 50 mg to solifenacin 5 mg further improved OAB symptoms compared to solifenacin 5 or 10 mg, and it was well tolerated in OAB patients remaining incontinent after initial therapy with solifenacin 5 mg.
Combination therapy for lower urinary tract symptoms (LUTS) is not new. Medical management of men with moderate to severe LUTS due to benign prostatic hyperplasia with α-blockers and 5-α reductase inhibitors (5-ARIs) is effective not only in improving LUTS but also in reducing the relative risk of disease progression [7]. More recently, it was shown that a combination of solifenacin and tamsulosin was efficacious in improving symptoms in patients who did not respond initially to α-blocker therapy [8]. The aim of these combinations is to add different mechanisms of actions to achieve an improvement in patient quality of life, which should involve control of symptoms with the lowest rate of adverse events.
In the study by Drake et al, the incidence of treatment emergent adverse events (TEAEs) was lowest for solifenacin 5 mg (33.1%), highest for solifenacin 10 mg (39.4%), and 35.9% for the combination. The incidence of dry mouth, the most common TEAE of antimuscarinics, was lower for the combination (5.9%) than for solifenacin 10 mg (9.5%) and similar to solifenacin 5 mg (5.6%). A general mean rise of 1 mm Hg in systolic blood pressure was observed between the combination and solifenacin monotherapy at end of treatment, which is attributable to mirabegron. There were no significant differences in vital signs, including subpopulations stratified by hypertensive status and β-blocker use, nor were there notable cardiovascular changes. A recent systematic review addressing the cardiovascular safety of β3-adrenoceptor agonists for the treatment of patients with OAB found that the cardiovascular safety of mirabegron appears to be good and comparable to that of antimuscarinic agents. However, because data for patients with poorly controlled hypertension, arrhythmia, or cardiac heart failure are currently lacking, periodic blood pressure and heart rate measurements are recommended for patients with significant cardiovascular risk factors, such as coronary heart disease and cardiomyopathy, and those aged >80 yr [9].
The findings reported by Drake et al suggest that combination therapy of solifenacin 5 mg and mirabegron 50 mg may be an alternative to dose escalation of solifenacin in patients with insufficient response to solifenacin 5 mg.
OAB is a complex condition affecting different patients who may be treated with different pharmacotherapy options and exhibit different responses. Some patients may primarily respond very well to initial therapy, while others do not. Combination therapy of solifenacin and mirabegron may contribute in optimising efficacy with an acceptable tolerability profile in comparison to a higher antimuscarinic dose. This approach may provide greater patient satisfaction, contributing to higher adherence and persistence rates and yielding a better efficacy-tolerability balance.
Barbara Padilla-Fernandez has received travel grants from Astellas, Almirall, and GebroPharma. David Castro-Diaz has been an investigator for Astellas and Allergan and a speaker for Astellas, Allergan, Pfizer, Medtronic, and Neo-Medic.
