ArticleTherapeutic advances in urology2015
The efficacy and safety of mirabegron compared with solifenacin in overactive bladder patients dissatisfied with previous antimuscarinic treatment due to lack of efficacy: results of a noninferiority, randomized, phase IIIb trial.
Article in Therapeutic advances in urology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers, 4 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
26 citing papers in PubMed, 4 syntheses or guidelines pooled it, 83 citations in OpenAlex.
- Mirabegron and Anticholinergics in the Treatment of Overactive Bladder Syndrome: A Meta-analysis.Revista brasileira de ginecologia e obstetricia : revista da Federacao Brasileira das Sociedades de Ginecologia e Obstetricia · 2023Pooled it
- Comparative Safety and Efficacy of Treatments for Overactive Bladder Among Older Adults: A Network Meta-analysis.Drugs & aging · 2020Pooled it
- Updating the evidence on drugs to treat overactive bladder: a systematic review.International urogynecology journal · 2019Pooled it
- Comparative assessment of efficacy and safety of approved oral therapies for overactive bladder: a systematic review and network meta-analysis.International braz j urol : official journal of the Brazilian Society of UrologyPooled it
- Mirabegron Add-On Therapy to Tamsulosin in Men with Overactive Bladder: Post Hoc Analyses of Efficacy from the MATCH Study.Advances in therapy · 2021Trial
- Efficacy and safety of mirabegron versus solifenacin in the treatment of overactive bladder in children: a systematic review and meta-analysis.BMC urology · 2026Article
- Examining the safety of mirabegron: an analysis of real-world pharmacovigilance data from the US FDA adverse event reporting system (FAERS) database.Frontiers in pharmacology · 2024Article
- Article
- Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults.The Cochrane database of systematic reviews · 2023Review
- Mirabegron, a β3‑adrenoreceptor agonist, regulates right and left atrial arrhythmogenesis differently.Experimental and therapeutic medicine · 2022Article
- Mirabegron and solifenacin are effective for the management of the increased urinary frequency induced by psychological stress in female mice.Scientific reports · 2022Article
- Mirabegron in the Management of Overactive Bladder Syndrome.International journal of women's health · 2022Review
- Efficacy and Safety of Mirabegron in Men with Overactive Bladder Symptoms and Benign Prostatic Hyperplasia.Current urology reports · 2021Review
- Editorial commentary on "Safety and Efficacy of Mirabegron: Analysis of a Large Integrated Clinical Trial Database of Patients with Overactive Bladder Receiving Mirabegron, Antimuscarinics, or Placebo".Translational andrology and urology · 2020Article
- Combination Pharmacotherapy for Treatment of Overactive Bladder (OAB).Current urology reports · 2019Review
- Article
- Nocturia and associated mortality: observational data from the REDUCE trial.Prostate cancer and prostatic diseases · 2019Article
- Diagnosis and Management of Bladder Dysfunction in Neurologically Normal Children.Frontiers in pediatrics · 2019Review
- The efficacy of mirabegron in the treatment of urgency and the potential utility of combination therapy.Therapeutic advances in urology · 2018Review
- Review
Corrections and comments
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Authors and funding
11 authors at 8 institutions in 7 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo compare the efficacy and safety of mirabegron 50 mg and solifenacin 5 mg in overactive bladder (OAB) patients dissatisfied with previous antimuscarinic treatment due to lack of efficacy. PATIENTS AND
methodsThis randomized, double-blind, phase IIIb, noninferiority study, enrolled male and female patients aged ⩾18 years old, with symptoms of OAB for ⩾3 months, who were dissatisfied with their previous antimuscarinic drug due to lack of efficacy. A total of 1887 patients were randomized to receive mirabegron 50 mg (n = 943) or solifenacin 5 mg (n = 944) daily for 12 weeks. The primary efficacy endpoint was change from baseline to end of treatment in mean number of micturitions/24 h. Noninferiority was confirmed if the lower limit of the two-sided 95% confidence interval (CI) for the treatment difference between solifenacin and mirabegron was > -0.20. Secondary efficacy endpoints, which included change from baseline in mean number of incontinence episodes/24 h, urgency incontinence episodes/24 h, urgency episodes (grade 3 or 4)/24 h and nocturia episodes/24 h, were analyzed using analysis of covariance.
resultsFor the primary endpoint, adjusted mean treatment difference (95% CI) in mean number of micturitions/24 h was -0.18 (-0.42, 0.06) and therefore noninferiority of mirabegron to solifenacin was not demonstrated. Both treatments demonstrated clinically meaningful reductions in efficacy variables and were well tolerated, with a lower incidence of dry mouth with mirabegron.
conclusionsNoninferiority of mirabegron compared with solifenacin for reduction in micturition frequency could not be demonstrated in this population of OAB patients who were dissatisfied with previous antimuscarinic therapy due to lack of efficacy. Both mirabegron and solifenacin improved key OAB symptoms with no statistically significant differences observed between the two treatments. Both drugs were well tolerated.
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Registered trials
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