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

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Summary

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.

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Acknowledgements

The authors would like to thank all the participating investigators of this multicentre study. They are: A Archimbaud, J Aurouze, G Chekly, B Crepin, E David, JL Descotes, J Dufour, F Faisant, the late G Faure, JP Gauthier, J Hermabessiere, A Jaupitre, B Mathes, JC Miermont, JJ Rambeaud, M Des Roseaux, E Schramek, G Sotton, C Vilain, L Vincens.

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Authors and Affiliations

  1. Centre Hospitalier Universitaire de Grenoble, Hôpital de la Tronche, Grenoble, France

    JL Descotes, JJ Rambeaud & G Faure

  2. Laboratoires Pierre Fabre, Division Internationale, Parc Industriel La Chartreuse, 81106, Castres Cedex, France

    Pascal Deschaseaux

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  1. JL Descotes
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  2. JJ Rambeaud
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  3. Pascal Deschaseaux
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  4. G Faure
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Descotes, J., Rambeaud, J., Deschaseaux, P. et al. Placebo-Controlled Evaluation of the Efficacy and Tolerability of Permixon® in Benign Prostatic Hyperplasia after Exclusion of Placebo Responders. Clinical Drug Investigation 9, 291–297 (1995). https://doi.org/10.2165/00044011-199509050-00007

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  • DOI: https://doi.org/10.2165/00044011-199509050-00007

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