Long-term sustained improvement in symptoms of benign prostatic hyperplasia with the dual 5alpha-reductase inhibitor dutasteride: results of 4-year studies.

Abstract

OBJECTIVE:

To report additional analyses of efficacy over the initial 2 years and during a 2-year open-label extension of the three pivotal phase 3 studies in which dutasteride, a dual inhibitor of type 1 and 2 5alpha-reductase, was shown to be effective and well tolerated.

PATIENTS AND METHODS:

All patients in the placebo and active groups were eligible for entry into the 2-year open-label extension, with all receiving dutasteride 0.5 mg daily. Mean changes from baseline were calculated for the American Urologic Association Symptom Index (AUA-SI) score at each scheduled time in the double-blind and open-label phase. The additional analyses included a breakdown of the AUA-SI score, including stratifying patients by symptom severity, assessment by baseline age and prostate volume, and the evaluation of symptoms responders.

RESULTS:

There was a clinically meaningful improvement in AUA-SI in patients on dutasteride in the double-blind phase, but not in those on placebo. At 48 months, patients on dutasteride in both study phases had greater improvements in AUA-SI score and individual question scores than those on dutasteride in the open-label phase only. The proportion of patients with severe symptoms declined in both study groups, although these changes were more profound in those receiving dutasteride for the 4-year duration of the study.

CONCLUSION:

In men with symptomatic benign prostatic hyperplasia, long-term (4-year) treatment with the dual isozyme 5alpha-reductase inhibitor dutasteride resulted in sustained and continued improvements in symptoms and flow rate. For 4 vs 2 years, longer dutasteride therapy resulted in greater symptom improvement.

• Authors: Claus G Roehrborn, Olavi Lukkarinen, Stephen Mark, Paul Siami, Joe Ramsdell, Norman Zinner
• Journal: BJU international (BJU Int) Vol. 96 Issue 4 Pg. 572-7 (Sep 2005) ISSN: 1464-4096 [Print] England
• PMID: 16104912 (Publication Type: Clinical Trial, Clinical Trial, Phase III, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• 5-alpha Reductase Inhibitors
• Azasteroids
• Isoenzymes
• Dutasteride

Topics

• 5-alpha Reductase Inhibitors
• Aged
• Azasteroids (therapeutic use)
• Double-Blind Method
• Dutasteride
• Follow-Up Studies
• Humans
• Isoenzymes (antagonists & inhibitors)
• Male
• Middle Aged
• Prostatic Hyperplasia (drug therapy)
• Time Factors
• Treatment Outcome