Study to Evaluate the Efficacy, Safety, and Tolerability of Mirabegron in Older Adult Subjects With Overactive Bladder (OAB)

Summary

The purpose of this study was to assess the efficacy, safety and tolerability of mirabegron versus placebo in the treatment of older adult subjects with OAB.

Timeline

Start

2014-10-07

Primary completion

2017-11-29

Completion

2018-01-02

Outcome

Met primary endpoint

registry LEAST_SQUARES_MEAN Placebo: -1.7 (Standard Error 0.2) micturitions/24 hours LEAST_SQUARES_MEAN Mirabegron: -2.3 (Standard Error 0.2) micturitions/24 hours analysis (superiority test); Placebo vs Mirabegron; p <0.001 NCT02216214 ↗

registry analysis (superiority test); Placebo vs Mirabegron; p <0.001; Least Squares Mean (LSM) Mean Difference -0.7 (95% CI -1.05 to -0.33); ANCOVA NCT02216214 ↗

registry LEAST_SQUARES_MEAN Placebo: -1.45 (Standard Error 0.13) incontinence episodes/24 hours LEAST_SQUARES_MEAN Mirabegron: -2.00 (Standard Error 0.13) incontinence episodes/24 hours analysis (superiority test); Placebo vs Mirabegron; p <0.001 NCT02216214 ↗

registry analysis (superiority test); Placebo vs Mirabegron; p <0.001; LSM Difference -0.55 (95% CI -0.82 to -0.27); ANCOVA NCT02216214 ↗

Publications

• Herschorn S, Staskin D, Schermer CR, Kristy RM, Wagg A. Safety and Tolerability Results from the PILLAR Study: A Phase IV, Double-Blind, Randomized, Placebo-Controlled Study of Mirabegron in Patients >/= 65 years with Overactive Bladder-Wet. Drugs Aging. 2020 Sep;37(9):665-676. doi: 10.1007/s40266-020-00783-w.
• Griebling TL, Campbell NL, Mangel J, Staskin D, Herschorn S, Elsouda D, Schermer CR. Effect of mirabegron on cognitive function in elderly patients with overactive bladder: MoCA results from a phase 4 randomized, placebo-controlled study (PILLAR). BMC Geriatr. 2020 Mar 18;20(1):109. doi: 10.1186/s12877-020-1474-7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Mirabegron	Other / unclassified	25 mg	Oral
Subject	Mirabegron	Other / unclassified	50 mg	Oral

Indications