AUA 2012 - The urodynamic safety of mirabegron based on a phase II bladder outlet obstruction (BOO) clinical trial - Special Report

ATLANTA, GA USA (UroToday) - In his podium presentation, Victor Nitti, MD, NYU Langone Medical Center, reported on the urodynamic safety of mirabegron based on a phase II bladder outlet obstruction (BOO) clinical trial (Abstract 1869).

Mirabegron was evaluated in 200 males with LUTS and BOO, an IPSS score greater than 8, and a bladder outlet obstruction index of greater than 20. The cohort was randomized 1:1:1 to receive oral mirabegron 50 mg, mirabegron 100 mg, or placebo once-a-day for 12 weeks. Researchers were looking at a population at risk for urinary retention. Each was assessed with a catheter in the bladder before treatment and then again after 12 weeks of treatment. Both mirabegron doses were non-inferior to the placebo in Qmax and PdetQmax. There were no serious TEAEs or deaths; one patient on the placebo and one patient on 100 mg mirabegron had urinary retention. Only the patient on the placebo required catheterization.

Dr. Nitti concluded urodynamic safety of mirabegron after 12 weeks of treatment was demonstrated and the 50mg and 100mg doses did not adversely affect flow rate detrusor pressure at max flow rate. Overall, the medication treatment was well tolerated with no influence of mirabegron on the voiding urodynamics of males with LUTS and BOO. 

commentary podcast by contributing study author Nancy Martin

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Presented by Victor Nitti, MD at the American Urological Association (AUA) Annual Meeting - May 19 - 23, 2012 - Georgia World Congress Center - Atlanta, GA USA

Vice-Chairman of Urology, NYU Langone Medical Center, New York, NY USA

 aua NittiVictor Nitti is a graduate of the University of Medicine and Dentistry of New Jersey and did his urology residency at SUNY Brooklyn. He then completed a fellowship in Female Urology, Neurourology and Reconstructive Urology at UCLA.

Dr. Nitti is a Fellow of the American College of Surgeons and the American Board of Urology and a member of the American Urological Association, the Society for Urodynamics and Female Urology, the International Continence Society and the First, Second, Third and Fourth International Consultations on Incontinence. He now serves as Vice President of SUFU.

Industry note: The mirabegron safety study mentioned in this article was sponsored by Astellas. This study adds to the existing compendium represented by more than 40 different clinical studies. As announced last month, mirabegron has been given a PDUFA action date of June 29, 2012. On April 5, 2012 the Reproductive Drugs Advisory Committee of the U.S. FDA voited that the overall risk and benefit assessment supports the approval of mirabegron for the treatment of overactive bladder.

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