Tadalafil once daily in the treatment of lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH) in men without erectile dysfunction. (13th August 2013)

• Record Type: Journal Article
• Authors: Brock, Gerald; Broderick, Gregory; Roehrborn, Claus G.; Xu, Lei; Wong, David; Viktrup, Lars
• Is Part Of: BJU international. Volume 112:Number 7(2013:Oct.)
• Page Start: 990
• Page End: 997
• Publication Date: 2013-08-13
• Subjects: Genitourinary organs -- Diseases -- Periodicals; Genitourinary organs -- Surgery -- Periodicals; Urology -- Periodicals; 616.6
• DOI: 10.1111/bju.12251
• Languages: English
• ISSNs: 1464-4096

Abstract

<abstract abstract-type="main"> <title> <x xml:space="preserve">Abstract</x> </title> <sec id="bju12251-sec-0001" sec-type="section"> <title>Objectives</title> <p> <list id="bju12251-list-0001" list-type="bullet"> <list-item> <p>To assess the safety and efficacy of tadalafil once daily on lower urinary tract symptoms suggestive of clinical benign prostatic hyperplasia (BPH‐LUTS) in men without erectile dysfunction (ED).</p> </list-item> <list-item> <p>To compare these with effects in men with ED.</p> </list-item> </list> </p> </sec> <sec id="bju12251-sec-0002" sec-type="section"> <title>Patients and Methods</title> <p> <list id="bju12251-list-0002" list-type="bullet"> <list-item> <p>After a 4‐week washout period and 4‐week placebo run‐in period, 1089 men without ED (<italic>n</italic> = 338) and with ED (<italic>n</italic> = 751) were randomly assigned to placebo or tadalafil 5 mg once daily for 12 weeks in three global clinical studies with similar designs.</p> </list-item> <list-item> <p>In the pooled dataset, <italic>post hoc</italic> analyses of covariance assessed the impact and severity of BPH‐LUTS using the International Prostate Symptom Score (IPSS) and the BPH Impact Index (BII) and IPSS quality‐of‐life (IPSS‐QoL) subscores.</p> </list-item> <list-item> <p>Safety was assessed using treatment‐emergent adverse events.</p> </list-item> <list-item> <p>The treatment‐by‐ED‐status interaction was used to assess efficacy differences between the with/without ED subgroups.</p> </list-item> </list> </p> </sec> <sec id="bju12251-sec-0003" sec-type="section"> <title>Results</title> <p> <list id="bju12251-list-0003" list-type="bullet"> <list-item> <p>Men without ED were similar in BPH‐LUTS severity/previous therapy to men with ED.</p> </list-item> <list-item> <p>Tadalafil significantly reduced BPH‐LUTS from baseline when compared with placebo in men without ED (IPSS −5.4 vs −3.3, <italic>P</italic> < 0.01; IPSS voiding subscore −3.5 vs −2.0, <italic>P</italic> < 0.01; IPSS storage subscore −1.9 vs −1.3, <italic>P</italic> < 0.05).</p> </list-item> <list-item> <p>Tadalafil also significantly improved quality of life from baseline when compared with placebo in men without ED (IPSS‐QoL −1.0 vs −0.7, BII −1.4 vs −1.0; both <italic>P</italic> < 0.05).</p> </list-item> <list-item> <p>Between‐ED‐subgroup interactions were not significant (all <italic>P</italic> > 0.68).</p> </list-item> <list-item> <p>Tadalafil was safe and well tolerated.</p> </list-item> </list> </p> </sec> <sec id="bju12251-sec-0004" sec-type="section"> <title>Conclusion</title> <p> <list id="bju12251-list-0004" list-type="bullet"> <list-item> <p>Tadalafil 5 mg once daily improved BPH‐LUTS in men without ED by a magnitude similar to that observed in men with ED.</p> </list-item> <list-item> <p>The adverse event profile in men without ED was consistent with that observed in men with ED.</p> </list-item> </list> </p> </sec> </abstract>