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Tadalafil once daily in the treatment of lower urinary tract symptoms ( LUTS ) suggestive of benign prostatic hyperplasia ( BPH ) in men without erectile dysfunction
Author(s) -
Brock Gerald,
Broderick Gregory,
Roehrborn Claus G.,
Xu Lei,
Wong David,
Viktrup Lars
Publication year - 2013
Publication title -
bju international
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.773
H-Index - 148
eISSN - 1464-410X
pISSN - 1464-4096
DOI - 10.1111/bju.12251
Subject(s) - tadalafil , lower urinary tract symptoms , medicine , placebo , urology , erectile dysfunction , international prostate symptom score , quality of life (healthcare) , overactive bladder , hyperplasia , adverse effect , benign prostatic hyperplasia (bph) , prostate , pathology , alternative medicine , nursing , cancer
Objectives 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 ). To compare these with effects in men with ED .Patients and Methods After a 4‐week washout period and 4‐week placebo run‐in period, 1089 men without ED ( n = 338) and with ED ( n = 751) were randomly assigned to placebo or tadalafil 5 mg once daily for 12 weeks in three global clinical studies with similar designs. In the pooled dataset, post hoc analyses of covariance assessed the impact and severity of BPH‐LUTS using the I nternational P rostate S ymptom S core ( IPSS ) and the BPH I mpact I ndex ( BII ) and IPSS quality‐of‐life ( IPSS ‐ QoL ) subscores. Safety was assessed using treatment‐emergent adverse events. The treatment‐by‐ ED ‐status interaction was used to assess efficacy differences between the with/without ED subgroups.Results Men without ED were similar in BPH‐LUTS severity/previous therapy to men with ED . Tadalafil significantly reduced BPH‐LUTS from baseline when compared with placebo in men without ED ( IPSS −5.4 vs −3.3, P < 0.01; IPSS voiding subscore −3.5 vs −2.0, P < 0.01; IPSS storage subscore −1.9 vs −1.3, P < 0.05). 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 P < 0.05). Between‐ ED ‐subgroup interactions were not significant (all P > 0.68). Tadalafil was safe and well tolerated.Conclusion Tadalafil 5 mg once daily improved BPH‐LUTS in men without ED by a magnitude similar to that observed in men with ED . The adverse event profile in men without ED was consistent with that observed in men with ED .