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Effects Of Once-Daily Tadalafil On Erectile Function In Men With Erectile Dysfunction And Signs And Symptoms Of Benign Prostatic Hyperplasia

UroToday.com - Men with benign prostatic hyperplasia (BPH) often suffer from lower urinary tract symptoms (LUTS; BPH-LUTS) such as urinary frequency, urgency, intermittency, nocturia, straining, incomplete emptying, or weak urinary stream. BPH-LUTS and erectile dysfunction (ED), both highly prevalent conditions in aging men, are frequently associated in the same men, may have common pathophysiological mechanisms, and contribute negatively to quality of life. Phosphodiesterase type 5 (PDE5) isozymes are considered promising targets for drug intervention in the urogenital tract, and the potential use of PDE5 inhibitors as treatment for both BPH LUTS and ED is of clinical interest. The PDE5 inhibitor tadalafil, currently approved for the treatment of erectile dysfunction and for the treatment of pulmonary arterial hypertension in some geographies, is being studied in men with signs and symptoms of BPH. Tadalafil"s 17.5-hour half-life makes it suitable for once-daily therapy. We report a post hoc analysis of 581 men from a 12-week, randomized, double-blind, placebo-controlled, parallel-group, multinational, dose-finding study of once-daily tadalafil conducted in men with BPH-LUTS. The men included in this analysis were sexually active with a female partner and also had ED, defined as a consistent change in the quality of erection that adversely affected patient satisfaction with sexual intercourse. We evaluated in these men changes in erectile function (International Index of Erectile Function-Erectile Function [IIEF-EF] domain score), changes in BPH-LUTS measures (International Prostate Symptom Score [IPSS], peak urinary flow rate [Qmax], and postvoid residual volume [PVR]), and safety with tadalafil once daily (2.5 mg, 5 mg, 10 mg, or 20 mg) vs. placebo. IIEF EF domain score improvements from baseline with once-daily tadalafil were significantly greater throughout the study for all tadalafil groups vs. placebo (all p values ð‰¤0.001). Once-daily tadalafil also improved IIEF-EF domain scores in clinically important subgroups of patients stratified according to age group, body mass index, BPH-LUTS severity, prostate-specific antigen (a surrogate for prostate size), prior α-blocker use, and prior ED therapy, suggesting that once-daily tadalafil may be effective in treating a broad group of men with BPH-LUTS. IPSS improvements from baseline to end point were significantly greater with all tadalafil doses vs. placebo (all p values UroToday - the only urology website with original content written by global urology key opinion leaders actively engaged in clinical practice. To access the latest urology news releases from UroToday, go to: www.urotoday.com Copyright © 2009 - UroToday


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