Placebo-Controlled Evaluation of the Efficacy and Tolerability of Permixon® in Benign Prostatic Hyperplasia after Exclusion of Placebo Responders

Abstract

A double-blind placebo-controlled multicentre study was conducted to assess the efficacy and tolerability of the 5α-reductase inhibitor Permixon® in patients with symptomatic benign prostatic hyperplasia (BPH) who had previously been shown to be unresponsive to the placebo effect. Following a 30-day single-blind placebo run-in period, 176 nonresponders to placebo (those patients showing <30% improvement in peak urinary flow rate) were randomised to double-blind oral treatment with Permixon® 160mg twice daily or matching placebo for 30 days. Improvement in dysuria severity was seen in a significantly greater proportion ofPermixon® recipients (31.3%) than placebo recipients (16.1%). Daytime urinary frequency fell significantly in Permixon®-treated patients (11.3% reduction), but was unchanged in placebo recipients. Nocturnal urinary frequency fell to a significantly greater extent with Permixon® (32.5% reduction) than with placebo (17.7% reduction). Permixon® produced a significantly greater increase in mean peak urinary flow rate than did placebo (28.9 vs 8.5%). The global efficacy of Permixon® was judged by the patients and physicians to be satisfactory or better in 71.3 and 56.6% of cases, respectively; corresponding values for placebo were 67.5 and 47.2%, respectively. The overall tolerability of Permixon® was comparable to that of placebo. In conclusion, Permixon® appears to be significantly more effective than placebo and well tolerated in the short term treatment of mild to moderate symptomatic BPH.