BJU international · 2011
Comparison of dutasteride and finasteride for treating benign prostatic hyperplasia: the Enlarged Prostate International Comparator Study (EPICS).
Сравнительное исследованиеСтатьяМногоцентровое исследованиеРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Nickel J Curtis, Gilling Peter, Tammela Teuvo L, Morrill Betsy, Wilson Timothy H, Rittmaster Roger S
Аннотация
OBJECTIVE: • To assess the efficacy and safety of dutasteride compared with finasteride in treating men with symptomatic benign prostatic hyperplasia (BPH) for 12 months.
PATIENTS AND METHODS: • The Enlarged Prostate International Comparator Study was a multicentre, randomized, double-blind, 12-month, parallel-group study. • Men aged ≥ 50 years with a clinical diagnosis of BPH received once-daily treatment with dutasteride 0.5 mg (n= 813) or finasteride 5 mg (n= 817). After a 4-week placebo run-in period, patients were randomized to receive dutasteride or finasteride for 48 weeks, followed by an optional 24-month, open-label phase, during which patients received dutasteride 0.5 mg once daily. • The primary endpoint was change in prostate volume, and the secondary endpoints included improvement in American Urological Association Symptom Index (AUA-SI) scores, improvement in maximum urinary flow rate (Q(max)) and long-term safety in the 24-month open-label phase.
RESULTS: • Both dutasteride and finasteride were effective at reducing prostate volume with no significant difference between the two treatments during the study. • Similar reductions in mean AUA-SI scores and Q(max) were also observed for men in both treatment groups. • A similar percentage of adverse events was experienced by patients of both treatment groups, and no new adverse events were reported in the open-label phase.
CONCLUSION: • Dutasteride and finasteride, when administered for 12 months, were similarly effective in reducing prostate volume and improving Q(max) and urinary symptoms associated with BPH in men with an enlarged prostate.
PATIENTS AND METHODS: • The Enlarged Prostate International Comparator Study was a multicentre, randomized, double-blind, 12-month, parallel-group study. • Men aged ≥ 50 years with a clinical diagnosis of BPH received once-daily treatment with dutasteride 0.5 mg (n= 813) or finasteride 5 mg (n= 817). After a 4-week placebo run-in period, patients were randomized to receive dutasteride or finasteride for 48 weeks, followed by an optional 24-month, open-label phase, during which patients received dutasteride 0.5 mg once daily. • The primary endpoint was change in prostate volume, and the secondary endpoints included improvement in American Urological Association Symptom Index (AUA-SI) scores, improvement in maximum urinary flow rate (Q(max)) and long-term safety in the 24-month open-label phase.
RESULTS: • Both dutasteride and finasteride were effective at reducing prostate volume with no significant difference between the two treatments during the study. • Similar reductions in mean AUA-SI scores and Q(max) were also observed for men in both treatment groups. • A similar percentage of adverse events was experienced by patients of both treatment groups, and no new adverse events were reported in the open-label phase.
CONCLUSION: • Dutasteride and finasteride, when administered for 12 months, were similarly effective in reducing prostate volume and improving Q(max) and urinary symptoms associated with BPH in men with an enlarged prostate.