Effects of alfuzosin 10 mg once daily on sexual function in men treated for symptomatic benign prostatic hyperplasia

Abstract

We evaluated the effects of extended-release alfuzosin HCl 10 mg once daily (q.d.) on sexual function in men with lower urinary tract symptoms associated with benign prostatic hyperplasia (BPH). In a randomized, double-blind, placebo-controlled study of men aged Z50 years, after a 28-day placebo run-in period, patients were randomized to receive alfuzosin 10 mg q.d. or matching placebo for 28 days. The mean change from baseline (day 1) in sexual function on day 29 was assessed using the Danish Prostate Symptom Score Sex (DAN-PSSsex) questionnaire. A total of 372 patients were randomized to receive alfuzosin (n ¼ 186) or placebo (n ¼ 186), with 355 completing the study. At baseline, 64% of the patients reported erectile dysfunction (ED) and 63% reported ejaculatory dysfunction (EjD). For the 320 patients who completed the DAN-PSSsex, alfuzosin treatment was associated with a significant improvement in the mean change from baseline in erectile function on day 29 compared with placebo (P ¼ 0.02). No significant difference was observed between the two treatment groups in the mean change from baseline in ejaculatory function on day 29. For patients with ED at baseline, a marginal improvement in erectile function was demonstrated with alfuzosin treatment (P ¼ 0.09 vs placebo). For patients with EjD at baseline, the mean change from baseline in ejaculatory function with alfuzosin was comparable to that with placebo. Dizziness was the most common adverse event with alfuzosin treatment (5 vs 0% with placebo), with other adverse events reported with comparable frequency in both treatment groups. After 1 month of treatment, alfuzosin 10 mg q.d. significantly improved erectile function in men with lower urinary tract symptoms/ benign prostatic hypertrophy and had no adverse effect on ejaculatory function.

Sexuality and the management of BPH with alfuzosin (SAMBA) trial

“…[7][8][9] Earlier reports concerning the clinical efficacy of alfuzosin in the treatment of symptomatic BPH and its concomitant effect on sexual function have suggested that the improvement in LUTSs is strongly associated with the improvement in sexual function. 10,11 Most of the earlier studies used changes in the Danish prostate symptom sex score (DAN-PSSsex) or the international index of erectile function (IIEF) questionnaire score as the parameter of improvement in sexual function. However, sexual function is complex and includes multiple domains, including sexual desire and erectile and ejaculatory functions.…”

Open label studies sufficiently demonstrate efficacy in improving sexual function

“…3 Double-blind comparative studies also failed to show significant benefits of alfuzosin over other a 1 -adrenoceptor antagonists with regard to sexual function. 4 Although the study by Chung et al confirms that we do not have to expect worsening of sexual function when using this or other a 1 -adrenoceptor antagonists, 3 we feel that claims for efficacy in improving sexual function based upon open-label studies are inappropriate. The key reason for this is that overall sexual function may also exhibit considerable improvement upon placebo treatment in men with voiding dysfunction.…”

“…[1][2][3] Furthermore, recent studies, not only in open label studies but also in randomized double-blind, placebo-controlled studies showed that Alfuzosin 10 mg once daily significantly improved LUTS and sexual function. [4][5][6] As you pointed out, we agree that efficacy in improving sexual function based upon doubleblind randomized comparative trial (RCT) are appropriate. Before considering the policy implications of our findings, some methodological aspects of the study need to be considered.…”

A systematic review of the correlates and management of nonpremature ejaculatory dysfunction in heterosexual men

“…A 3-year follow up of European men treated with alfuzosin 10 mg once daily for LUTS suggestive of BPH in 'real-life practice' showed that ejaculatory disorders were uncommon (0.4%) [Vallancien et al 2008]. In a prospective study evaluating the effect of alfuzosin on sexual function in men with LUTS, after 1 month of treatment, men had no adverse effect on ejaculatory function [Rosen et al 2007]. On the other hand, alfuzosin treatment in men with LUTS was associated with improvement in ejaculatory function.…”