Safety and tolerability of the dual 5α-reductase inhibitor dutasteride in the treatment of benign prostatic hyperplasia

被引:137
作者
Andriole, GL
Kirby, R
机构
[1] Washington Univ, Sch Med, Div Urol Surg, St Louis, MO 63110 USA
[2] Univ London St Georges Hosp, Dept Urol, London, England
关键词
dutasteride; BPH; safety; tolerability;
D O I
10.1016/S0302-2838(03)00198-2
中图分类号
R5 [内科学]; R69 [泌尿科学(泌尿生殖系疾病)];
学科分类号
1002 ; 100201 ;
摘要
Objective: The objective of this paper is to examine safety and tolerability data from a number of recently completed clinical trials with the novel, dual 5alpha-reductase inhibitor, dutasteride. Methods: Intent-to-treat analyses were conducted on data for dutasteride 0.5 mg/day for drug-related adverse events, clinical laboratory test results, and prostate-specific antigen (PSA) levels derived from four large, randomised, double-blind clinical trials (n = 5655). Further data were derived from a randomised, double-blind combination study of dutasteride 0.5 mg/day and tamsulosin 0.4 mg/day (n - 327), and several safety studies conducted in healthy volunteers. Results: Data from two-year blinded clinical studies demonstrate that dutasteride Is well tolerated, with a profile comparable with that of placebo. The exception is a modestly elevated incidence of impotence, decreased libido, ejaculation disorders, and gynaecomastia. Clinical laboratory test abnormalities were reported by <1% of patients treated with dutasteride, and abnormal values occurred with similar frequency versus placebo-treated patients. In a healthy volunteer study, when dutasteride was administered daily for I year, it did not significantly affect bone metabolism markers, bone mineral density or lipid profiles. Dutasteride reduced total serum PSA concentrations by similar to50% following 6, 12, and 24 months of treatment but had no effect on free-to-total PSA levels. The safety profile of dutasteride did not differ from that of dutasteride in a large, parallel-group, comparator trial. Additionally, when dutasteride was used in combination with an alpha(1)-blocker, the drug-related adverse event profiles were as would be expected for the individual agents. Conclusions: Considered together, these data demonstrate dutasteride to be well-tolerated. (C) 2003 Elsevier Science B.V. All rights reserved.
引用
收藏
页码:82 / 88
页数:7
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