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

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.
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.
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.
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.
AuthorsClaus G Roehrborn, Olavi Lukkarinen, Stephen Mark, Paul Siami, Joe Ramsdell, Norman Zinner
JournalBJU international (BJU Int) Vol. 96 Issue 4 Pg. 572-7 (Sep 2005) ISSN: 1464-4096 [Print] England
PMID16104912 (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
  • 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

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