Efficacy and Safety of Vibegron for Persistent Symptoms of Overactive Bladder in Men Being Pharmacologically Treated for Benign Prostatic Hyperplasia: Results From the Phase 3 Randomized Controlled COURAGE Trial

被引:13
作者
Staskin, David [1 ]
Owens-Grillo, Janet [2 ]
Thomas, Elizabeth [2 ]
Rovner, Eric [3 ]
Cline, Kevin [4 ]
Mujais, Salim [2 ]
机构
[1] Tufts Univ, Sch Med, Dept Urol, Boston, MA USA
[2] Sumitomo Pharm Amer Inc, Marlborough, MA 01752 USA
[3] Med Univ South Carolina, Dept Urol, Charleston, SC USA
[4] Louisiana State Univ Hlth, Dept Urol, Shreveport, LA USA
关键词
anticholinergics; beta-3 adrenergic agonist; overactive bladder; benign prostatic hyperplasia; URINARY-TRACT SYMPTOMS; DOUBLE-BLIND; MIRABEGRON; THERAPY;
D O I
10.1097/JU.0000000000003999
中图分类号
R5 [内科学]; R69 [泌尿科学(泌尿生殖系疾病)];
学科分类号
1002 ; 100201 ;
摘要
Purpose: The efficacy and safety of vibegron, a beta(3)-adrenergic receptor agonist, was assessed among men with symptoms of overactive bladder (OAB) receiving pharmacologic treatment for benign prostatic hyperplasia (BPH) in a phase 3 randomized controlled trial. Materials and Methods: Men >= 45 years with OAB symptoms and BPH, treated with alpha-blocker with/without 5 alpha-reductase inhibitors, were randomized 1:1 to vibegron or placebo for 24 weeks. Coprimary end points were change from baseline at week 12 in mean daily micturitions and urgency episodes. Secondary end points were change from baseline at week 12 in mean nightly nocturia and daily urge urinary incontinence episodes, International Prostate Symptom Score-storage score, and volume voided per micturition. Safety was evaluated via adverse events (AEs). Results: Of 1105 participants randomized, 965 (87.3%) completed the trial. At week 12, vibegron was associated with significant reductions vs placebo in daily micturitions (least squares mean difference [95% CI], -0.74 [-1.02, -0.46]; P < .0001) and urgency episodes (-0.95 [-1.37, -0.54]; P < .0001). Vibegron was also associated with significant improvements vs placebo at week 12 in nocturia episodes (least squares mean difference, -0.22 [-0.36, -0.09]; P = .002), urge urinary incontinence episodes (-0.80 [-1.33, -0.27]; P = .003), International Prostate Symptom Score-storage scores (-0.9 [-1.2, -0.6]; P < .0001), and volume voided (15.07 mL [9.13-21.02]; P < .0001). AE rates were similar in vibegron (45.0%) and placebo (39.0%) arms; AEs occurring in >= 2% of participants were hypertension (9.0% vs 8.3%), COVID-19 (4.0% vs 3.1%), UTI (2.5% vs 2.2%), and hematuria (2.0% vs 2.5%). Conclusions: In this trial, vibegron met all primary and secondary end points and was safe and well tolerated in men with OAB symptoms and pharmacologically treated BPH.
引用
收藏
页码:256 / 266
页数:11
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