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Proposal 1587

Title of the Proposed Research

Sex-specific efficacy of mirabegron for overactive bladder (OAB) symptoms: individual patient data meta-analyses

Lead Researcher

Marco H. Blanker, MD PhD

Affiliation

Dept. of general practice, University Medical Center Groningen, University of Groningen, the Netherlands

Funding Source

None

Potential Conflicts of Interest

Summary for all Researchers and Statistician None

Data Sharing Agreement Date

27 June 2017

Lay Summary

Overactive bladder syndrome is a common condition including a number of highly bothersome symptoms such as rushing to the toilet, leaking urine before reaching a toilet, and voiding too often both during the day and night. This problem affects hundreds of million men and women worldwide, and gets more common with age.

Doctors try to treat overactive bladder with different drugs. Most often drugs to relax the bladder, called ‘anti-muscarinic’ drugs, are used. Unfortunately, the effect of these drugs is disappointing for many patients. Up to eighty percent of patients stop these drugs within a few months, either because of severe side-effects or simply because they do not work well.

Recently, a new drug has become available for overactive bladder, called mirabegron. Studies demonstrate clearly that mirabegron is slightly more effective than a placebo (a fake drug / sugar pills), but it is unclear whether the drug works better for men or women. Such a difference is important because overactive bladder has different causes in men and women, with many men suffering symptoms of overactive bladder due to swelling of the prostate gland.

We therefore aim to study the difference in effect between men and women of mirabegron. We will combine all available data from different studies, without needing to perform a new trial in patients. For men and women, we will compare the change in symptoms at 6 weeks, 3 months, and one year, looking both at studies where mirabegron was tested as an alternative to placebo, and studies where it was tested against another drug.

The results of our analyses may enable physicians to target the use of mirabegron better. We will inform physicians about the results from our study with publication in specialist journals and presentations at scientific meetings. We will inform patients, patient organisations and policy makers by publicising our results in the lay press as well.

Study Data Provided

ASTELLAS-178-CL-049: A Randomized, Double-Blind, Parallel Group, Active Controlled, Multi-center Long-term Study to Assess the Safety and Efficacy of the Beta-3 Agonist Mirabegron (YM178) 50 mg qd and 100 mg qd in Subjects with Symptoms of Overactive Bladder.
ASTELLAS-178-CL-074: A Phase III, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Multicenter Study to Assess the Efficacy and Safety of the Beta-3 Agonist Mirabegron (25 mg qd and 50 mg qd) in Subjects with Symptoms of Overactive bladder.
ASTELLAS-178-EC-001: A Double-Blind, Randomized, Parallel Group, Multi-Centre Study to Evaluate the Efficacy and Safety of Mirabegron Compared to Solifenacin in Subjects with Overactive Bladder (OAB) Treated with Antimuscarinics and Dissatisfied due to Lack of Efficacy.
ASTELLAS-178-CL-046: A Randomized, Double-blind, Parallel Group, Placebo and Active Controlled, Multicenter Study to Assess the Efficacy and Safety of Mirabegron in Subjects with Symptoms of Overactive Bladder.
ASTELLAS-178-CL-047: A Phase III, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Multicenter Study to Assess the Efficacy and Safety of Mirabegron in Subjects with Symptoms of Overactive Bladder.
ASTELLAS-178-CL-048: Phase III Study of YM178: A double-blind group comparison study in patients with overactive bladder
ASTELLAS-178-CL-008: A randomized, double-blind, parallel group, proof of concept study of YM178 in comparison with placebo and tolterodine in patients with symptomatic overactive bladder
ASTELLAS-178-CL-044: A randomized, double-blind, parallel-group, placebo and active controlled, multi-center dose ranging study with beta-3 agonist YM178 in patients with symptomatic overactive bladder (DRAGON)
ASTELLAS-178-CL-090: A Phase 3, Randomized, Double-Blind, Parallel Group, Placebo and Active Controlled, Multicenter Study to Assess the Efficacy and Safety of Mirabegron (YM178) in Asian Patients with Symptoms of Overactive Bladder
ASTELLAS-178-CL-045: YM178 Phase II study - A Randomized, Double-blind, Parallel-group, Placebo-controlled Study in Patients With Symptomatic Overactive Bladder

Statistical Analysis Plan

Publication Citation

The publication citation will be added after the research is published.

Summary Results

Results summary or link will be posted when available.