Comparative Efficacy and Safety of the β3-Adrenoceptor Agonist Vibegron for Urgency and Mixed Urinary Incontinence: A Post Hoc Analysis of a Randomized, Double-Blind, Placebo-Controlled Phase 3 Study.

Objective To compare the efficacy of vibegron for urgency urinary incontinence (UUI) and mixed urinary incontinence (MUI) in patients with overactive bladder (OAB). Methods We performed a post hoc analysis of a phase 3 study of vibegron in Japanese patients with OAB. Based on the patterns recorded in the three-day bladder diary, only female patients were categorized into UUI and MUI populations.

Efficacy and safety of avacopan in Japanese patients with antineutrophil cytoplasmic antibody-associated vasculitis: A subanalysis of a randomized Phase 3 study.

Objectives: This subgroup analysis of the randomized, double-blind, Phase 3 ADVOCATE study evaluated the efficacy and safety of avacopan compared with tapered prednisone in Japanese patients with antineutrophil cytoplasmic antibody-associated vasculitis.

Methods: Patients with microscopic polyangiitis (MPA) or granulomatosis with polyangiitis (GPA) received either avacopan 30 mg twice daily for 52 weeks plus prednisone-matching placebo or tapered prednisone over 20 weeks plus avacopan-matching placebo for 52 weeks. The two primary efficacy endpoints were clinical remission at Week 26 and sustained remission at Week 52.

Post-Marketing Surveillance of Silodosin in Patients with Benign Prostatic Hyperplasia and Poor Response to Existing Alpha-1 Blockers: The SPLASH Study.

Objectives: Our objective was to investigate the effectiveness and safety of silodosin in patients with benign prostatic hyperplasia (BPH) who switched to silodosin from another α blocker because of inadequate response.

Methods: This was a prospective observational study conducted at 715 medical facilities in Japan in patients with BPH who received an α blocker other than silodosin for at least 3 months but had experienced unsatisfactory treatment outcomes. Patients completed questionnaires, including the International Prostate Symptom Score (IPSS), quality of life (QOL) score and Overactive Bladder Symptom Score (OABSS) at baseline (time of switching) and after 3 months of treatment with silodosin.