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. (7th March 2015)

• Record Type: Journal Article
• Authors: Nickel, John Curtis; Brock, Gerald B.; Herschorn, Sender; Dickson, Ruth; Henneges, Carsten; Viktrup, Lars
• Is Part Of: BJU international. Volume 115:Number 5(2015:May)
• Page Start: 815
• Page End: 821
• Publication Date: 2015-03-07
• Subjects: Genitourinary organs -- Diseases -- Periodicals; Genitourinary organs -- Surgery -- Periodicals; Urology -- Periodicals; 616.6
• DOI: 10.1111/bju.12926
• Languages: English
• ISSNs: 1464-4096

Abstract

<abstract abstract-type="main" id="bju12926-abs-0001"> <title> <x xml:space="preserve">Abstract</x> </title> <sec id="bju12926-sec-0001" sec-type="section"> <title>Objectives</title> <p>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.</p> </sec> <sec id="bju12926-sec-0002" sec-type="section"> <title>Patients and Methods</title> <p> <italic>Post hoc</italic> integrated analysis of four placebo‐controlled studies in men (aged ≥45 years; International Prostate Symptom Score [IPSS] of ≥13; maximum urinary flow rate [Q<sub>max</sub>] 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.</p> </sec> <sec id="bju12926-sec-0003" sec-type="section"> <title>Results</title> <p>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; <italic>P</italic> < 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; <italic>P</italic> < 0.001]).</p> </sec> <sec id="bju12926-sec-0004" sec-type="section"> <title>Conclusion</title> <p>About two‐thirds of tadalafil‐treated patients achieve a clinically meaningful improvement in BPH‐LUTS symptoms, based on two different definitions of responder status.</p> </sec> </abstract>