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:
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.
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.
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