International Phase III, Randomized, Double-Blind, Placebo and Active Controlled Study to Evaluate the Safety and Efficacy of Vibegron in Patients with Symptoms of Overactive Bladder: EMPOWUR
| Autor: | David R. Staskin, Denise Shortino, Rachael Jankowich, Paul N. Mudd, Susann Varano, Jeffrey Frankel |
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| Rok vydání: | 2020 |
| Předmět: |
Agonist
Adult Male medicine.medical_specialty Internationality Pyrrolidines Tolterodine Tartrate medicine.drug_class Urology 030232 urology & nephrology Adrenergic beta-3 Receptor Agonists Urinary incontinence Pyrimidinones Placebo Double blind 03 medical and health sciences 0302 clinical medicine Double-Blind Method medicine Humans Aged Urinary bladder business.industry Urinary Bladder Overactive Middle Aged medicine.disease medicine.anatomical_structure Tolerability Overactive bladder Delayed-Action Preparations Urological Agents Female medicine.symptom business |
| Zdroj: | The Journal of urology. 204(2) |
| ISSN: | 1527-3792 |
| Popis: | We assessed efficacy, safety and tolerability of vibegron, a novel, potent, highly selective βAdult patients with overactive bladder with 8.0 or more micturitions per day were randomized 5:5:4 to 75 mg vibegron, placebo or extended-release 4 mg extended-release tolterodine. Up to 25% of patients could have dry overactive bladder (less than 1.0 urge incontinence episode per day). Patients completed 7-day voiding diaries at baseline and weeks 2, 4, 8 and 12.Of 1,518 randomized patients 90.4% completed the trial. At 12 weeks micturitions decreased by an adjusted mean of 1.8 episodes per day for vibegron vs 1.3 for placebo (p0.001, co-primary end point) and 1.6 for tolterodine. Among incontinent patients urge incontinence episodes decreased by an adjusted mean 2.0 episodes per day for vibegron vs 1.4 for placebo (p0.0001, co-primary end point) and 1.8 for tolterodine. Moreover, vibegron was statistically significantly superior to placebo for key secondary measures of number of urgency episodes, volume per micturition and proportion of incontinent patients with a 75% or greater reduction in urge incontinence episodes (all p0.01). Among vibegron treated patients 1.7% discontinued treatment because of adverse events vs 1.1% for placebo and 3.3% for tolterodine. Incidence of hypertension was 1.7% for vibegron and for placebo.Once daily 75 mg vibegron provided statistically significant reductions in micturitions, urgency episodes and urge incontinence, and increased the volume per micturition. Treatment was well tolerated with a favorable safety profile. |
| Databáze: | OpenAIRE |
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