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


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 International Prostate Symptom Score (IPSS) and the BPH Impact Index (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.


CONCLUSIONS
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.
St Joseph's Health Care London, University of Western Ontario, London, Canada.
Gerald
G
Brock
Gregory
G
Broderick
Claus G
CG
Roehrborn
Lei
L
Xu
David
D
Wong
Lars
L
Viktrup
D002243:Carbolines / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D007172:Erectile Dysfunction / Q000150:complications; D006801:Humans; D059411:Lower Urinary Tract Symptoms / Q000150:complications / Q000188:drug therapy* / Q000209:etiology*; D008297:Male; D008875:Middle Aged; D058986:Phosphodiesterase 5 Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D011470:Prostatic Hyperplasia / Q000150:complications*; D000068581:Tadalafil
D002243:Carbolines; D058986:Phosphodiesterase 5 Inhibitors; D000068581:Tadalafil
BPH; LUTS; erectile dysfunction; lower urinary tract symptoms; phosphodiesterase type 5 inhibitors; prostatic hyperplasia; tadalafil