AUA 2019: Late-Breaking Abstract: Efficacy and Safety of Mirabegron vs. Placebo Add-on Therapy in Men with Overactive Bladder Symptoms receiving Tamsulosin for Underlying Benign Prostatic Hyperplasia (PLUS)
Men aged 40 or older who’s been taking tamsulosin for 2 or more months were enrolled in the study in North America and Europe. Subjects received a run-in dose of 0.4 mg of tamsulosin for 4 weeks. Then they were randomized based on the results of a voiding diary and PSA levels to the 0.4 mg tamsulosin + placebo group or 0.4 mg tamsulosin + 50 mg mirabegron. Participants were followed for 12 weeks. Study endpoints included changes in a number of voids, mean number of urge incontinence episodes per day, and IPSS total score.
Total of 676 men were recruited to the trial. Table 1 reflects sample characteristics:
Table 1
Study results demonstrate that tamsulosin + mirabegron significantly decreased mean number of voids per day compared to tamsulosin + placebo group (-0.39(-0.76, -0.02), p=0.039). Additionally, dual combination was associated with a significant change in a volume voided compared to the placebo group (Figure 1). Data demonstrate a statistically significant change in a number of urgency episodes per day in the intervention group.
Figure 1
Tamsulosin in combination with mirabegron showed favorable safety outcomes (Table 2). Overall, research indicates that mirabegron is superior in efficacy to placebo and can be a useful add-on to tamsulosin for men with LUTS related to BPH.
Table 2
Presented by: Steven A. Kaplan, MD, FACS, Professor of Urology, Director, The Men's Health Program, Icahn School of Medicine at Mount Sinai, New York City, New York
Written by: Hanna Stambakio, BS, Clinical Research Coordinator, Division of Urology, University of Pennsylvania, @AStambakio at American Urological Association's 2019 Annual Meeting (AUA 2019), May 3 – 6, 2019 in Chicago, Illinois