Long-term Safety and Efficacy of Mirabegron and Solifenacin in Combination Compared with Monotherapy in Patients with Overactive Bladder: A Randomised, Multicentre Phase 3 Study (SYNERGY II)

Gratzke, Christian; Maanen, Rob van; Chapple, Christopher R.; Abrams, Paul; Herschorn, Sender; Robinson, Dudley; Ridder, Arwin; Stoelzel, Matthias; Paireddy, Asha; Yoon, Sang Jin; Al-Shukri, Salman Hasunovich; Rechberger, Tomasz

doi:10.1016/j.eururo.2018.05.005

Cited by 88 publications

(85 citation statements)

References 16 publications

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“…In terms of safety, slightly higher incidences of TEAEs were observed following combination therapy versus mirabegron and solifenacin monotherapy regardless of age group. This observation concurs with the entire study population results and previous shorter‐term studies involving this combination . In agreement with the BESIDE age subgroup analysis, slightly higher incidences of overall TEAEs were observed in the older age groups in the present study versus the younger age groups.…”

Section: Discussionsupporting

confidence: 93%

“…The finding that all three treatments were associated with numerical improvements in both the primary and secondary efficacy variables agrees with the results from the entire patient population in this study and previous investigations that have examined the efficacy of combination, mirabegron, or solifenacin therapy according to patient age subgroups . Combination therapy was typically associated with greater improvements in all efficacy variables versus both monotherapies, similar to the findings from the BESIDE age subgroup analysis .…”

Section: Discussionsupporting

confidence: 90%

“…The methodology for this study has previously been reported . Briefly, patients aged ≥18 years with symptoms of “wet” OAB (urinary frequency and urgency with urgency urinary incontinence or mixed incontinence with urgency as the predominant factor) for ≥3 months were eligible for inclusion.…”

Section: Methodsmentioning

confidence: 99%

“…Randomization was stratified by sex, age group (<65, ≥65 years), and geographic region. Further details about the sample size calculations and the randomization process have been published previously …”

Section: Methodsmentioning

confidence: 99%

“…To date, SYNERGY II is the only clinical trial to evaluate the long‐term tolerability and effectiveness of mirabegron and solifenacin in combination. This study was a 12‐month phase III trial involving patients with OAB symptoms that investigated the safety and efficacy of the combination of solifenacin and mirabegron (5 mg/day and 50 mg/day, respectively) versus each monotherapy . With combination therapy, statistically significant improvements in changes from baseline in mean number of incontinence episodes and micturitions were observed versus each monotherapy.…”

Section: Introductionmentioning

confidence: 99%

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Long‐term treatment of older patients with overactive bladder using a combination of mirabegron and solifenacin: a prespecified analysis from the randomized, phase III SYNERGY II study

Maanen

Chapple

Abrams

et al. 2019

Neurourology and Urodynamics

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AimsSYNERGY II was a 12‐month phase III trial in patients with overactive bladder (OAB) symptoms that investigated the safety and efficacy of the combination of mirabegron and solifenacin in comparison with each monotherapy. This analysis evaluated the trial findings using four age subgroups (<65, ≥65, <75, and ≥75 years).MethodsEligible patients were ≥18 years with symptoms of “wet” OAB (urinary frequency and urgency with incontinence) for ≥3 months. Patients were randomized to receive once‐daily solifenacin succinate and mirabegron (5 mg/50 mg; combination), solifenacin succinate, or mirabegron (4:1:1). Safety evaluations: treatment‐emergent adverse events (TEAEs), vital signs, and electrocardiogram, post‐void residual volume, and laboratory assessments. Primary efficacy variables: change from baseline to end of treatment in number of incontinence episodes/24 h and micturitions/24 h.ResultsOf 1794 patients (full analysis set), 614 (34.2%) and 168 (9.4%) were ≥65 and ≥75 years old, respectively. Overall, 856 (47.2%) patients experienced ≥1 TEAE. Higher TEAE incidences were typically observed for the combination versus both monotherapies (eg, constipation) and in the older versus younger age groups (eg, urinary tract infection). Increases in mean pulse rate from baseline of >1 bpm were noted in the combination and mirabegron younger age groups only. No clinically significant findings were observed in the other safety parameters. The efficacy variables improved with all treatments and the greatest improvements were typically observed with combination therapy.ConclusionsMirabegron and solifenacin combination therapy was a well‐tolerated and effective treatment for patients with OAB symptoms irrespective of their age.

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Section: Discussionsupporting

confidence: 93%

Section: Discussionsupporting

confidence: 90%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

Long‐term treatment of older patients with overactive bladder using a combination of mirabegron and solifenacin: a prespecified analysis from the randomized, phase III SYNERGY II study

Maanen

Chapple

Abrams

et al. 2019

Neurourology and Urodynamics

Self Cite

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Concomitant Use of Sodium‐Glucose Cotransporter 2 Inhibitors and Overactive Bladder Drugs and the Risk of Urinary Tract Infection

Bea,

Lee,

Park

et al. 2024

Clin Pharma and Therapeutics

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Concomitant use of sodium glucose cotransporter‐2 inhibitors (SGLT‐2i) and overactive bladder (OAB) drugs potentially poses a risk of urinary tract infections (UTIs) due to the urinary retention of highly concentrated glucose in the urine. Thus, this study aimed to investigate the risk of UTIs among patients who initiated SGLT‐2i treatment while taking OAB drugs. This population‐based cohort study included new‐users of SGLT‐2i or comparator antidiabetics (dipeptidyl peptidase‐4 inhibitor (DPP‐4i); glucagon‐like peptide‐1 receptor agonist (GLP‐1RA)) with OAB drugs between 2014 and 2020 using claim data from Korea. Primary outcome was a composite UTI event composite end point comprising pyelonephritis, cystitis, and urethritis, using both inpatient and outpatient diagnoses. Propensity score fine stratification was used to adjust for potential confounding factors. Weighted hazard ratios (HR) were calculated using the Cox proportional hazards model. In the first cohort, 796 and 9,181 new‐users of SGLT‐2i and DPP‐4i with OAB drugs were identified, respectively. This study found a similar risk of UTIs in concomitant users of SGLT‐2i and DPP‐4i (weighted HR 1.08, 95% confidence interval: 0.88–1.32) with OAB drugs. In the second cohort, 2,387 and 280 new‐users of SGLT‐2i and GLP‐1RA with OAB drugs were identified, respectively. Initiation of SGLT‐2i while on OAB treatment was not associated with increased risk of UTI (0.89, 0.50–1.60), compared with initiation of GLP‐1RA. These results show that the concomitant use of SGLT‐2i with OAB drugs was not associated with an increased risk of UTI compared with the concomitant use of DPP‐4i or GLP‐1RA with OAB drugs.

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Meta‐analysis of the efficacy and safety of mirabegron and solifenacin monotherapy for overactive bladder

Wang

Zhou

Cui

et al. 2018

Neurourology and Urodynamics

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Aim:We conducted a meta-analysis to evaluate the safety and efficacy of mirabegron (50 mg) and solifenacin (5 mg) monotherapy for overactive bladder (OAB) during a 12-week cycle. Methods: Randomized controlled trials (RCTs) of mirabegron and solifenacin for OAB were searched systematically by using MEDLINE, EMBASE, and the Cochrane Controlled Trials Register. The reference lists of retrieved studies were also perused. Results: Five RCTs which compared solifenacin with mirabegron were studied.Mirabegron achieved the same effect as solifenacin in treating OAB. The mean number of incontinence episodes per 24 h (P = 0.20), mean number of micturitions per 24 h (P = 0.11), mean number of urgency episodes per 24 h (P = 0.23), and mean volume voided per micturition (P = 0.05) suggested that mirabegron and solifenacin had no significant differences in terms of OAB treatment. With regard to drug-related treatment-emergent adverse events (DR-TEAEs) and dry mouth, mirabegron showed better tolerance than solifenacin. Post-voiding residual volume showed a distinct difference in the two groups. Hypertension and tachycardia did not show a significant difference between the two groups, but the pulse rate did. Conclusion: The therapeutic effect of mirabegron is similar to that of solifenacin, and mirabegron does not increase the risk of adverse events (AEs). K E Y W O R D Smeta-analysis, mirabegron, overactive bladder, randomized controlled trials, solifenacin

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Long-term Safety and Efficacy of Mirabegron and Solifenacin in Combination Compared with Monotherapy in Patients with Overactive Bladder: A Randomised, Multicentre Phase 3 Study (SYNERGY II)

Cited by 88 publications

References 16 publications

Long‐term treatment of older patients with overactive bladder using a combination of mirabegron and solifenacin: a prespecified analysis from the randomized, phase III SYNERGY II study

Long‐term treatment of older patients with overactive bladder using a combination of mirabegron and solifenacin: a prespecified analysis from the randomized, phase III SYNERGY II study

Concomitant Use of Sodium‐Glucose Cotransporter 2 Inhibitors and Overactive Bladder Drugs and the Risk of Urinary Tract Infection

Meta‐analysis of the efficacy and safety of mirabegron and solifenacin monotherapy for overactive bladder

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