Proportion of tadalafil‐treated patients with clinically meaningful improvement in lower urinary tract symptoms associated with benign prostatic hyperplasia – integrated data from 1 499 study participants

• Published in: BJU international Vol. 115; no. 5; pp. 815 - 821
• Main Authors: Nickel, John Curtis, Brock, Gerald B., Herschorn, Sender, Dickson, Ruth, Henneges, Carsten, Viktrup, Lars
• Format: Journal Article
• Language: English
• Published: England Wiley Subscription Services, Inc 01.05.2015
• Subjects: benign prostatic hyperplasia; Carbolines - therapeutic use; Confidence intervals; Double-Blind Method; Drug therapy; Humans; Lower Urinary Tract Symptoms - drug therapy; Lower Urinary Tract Symptoms - etiology; Male; meaningful improvement; Men; Middle Aged; Phosphodiesterase 5 Inhibitors - therapeutic use; Prostatic Hyperplasia - complications; Remission Induction; Tadalafil; Urogenital system; meaningful improvement; benign prostatic hyperplasia; tadalafil
• ISSN: 1464-4096; 1464-410X
• DOI: 10.1111/bju.12926

Objectives To evaluate the proportion of patients achieving clinically meaningful improvement of lower urinary tract symptoms suggestive of benign prostatic hyperplasia (BPH‐LUTS) with tadalafil using two definitions of response. Patients and Methods Post hoc integrated analysis of four placebo‐controlled studies in men (aged ≥45 years; International Prostate Symptom Score [IPSS] of ≥13; maximum urinary flow rate [Qmax] of ≥4 to ≤15 mL/s) with BPH‐LUTS randomised to tadalafil 5 mg (752 patients) or placebo (747) for 12 weeks after a 4‐week placebo run‐in. Responders were defined as having a total IPSS improvement of ≥3 points or ≥25% from randomisation to endpoint (Week 12). Response status was calculated per patient, and relative benefit and odds ratio (OR) with 95% confidence interval (CI) of tadalafil vs placebo was calculated using a logistic Generalised Mixed Model for Repeated Measures. Results Tadalafil 5 mg once daily resulted in a significantly greater proportion of patients achieving a ≥3‐point IPSS improvement (71.1% and 56.0% for tadalafil and placebo patients, respectively [OR 1.9, 95% CI 1.5, 2.4; P < 0.001]) and achieving a ≥25% improvement in total IPSS randomisation to endpoint (61.7% and 45.5% for tadalafil and placebo patients, respectively [OR 2.0, 95% CI 1.6, 2.5; P < 0.001]). Conclusion About two‐thirds of tadalafil‐treated patients achieve a clinically meaningful improvement in BPH‐LUTS symptoms, based on two different definitions of responder status.