Dutasteride

Drugs Aging. 2003;20(12):905-16; discussion 917-8. doi: 10.2165/00002512-200320120-00005.

Abstract

Dutasteride, a potent inhibitor of type 1 and 2 5alpha-reductase, reduced dihydrotestosterone levels by >90% in 85% of patients following 1 years' administration of oral dutasteride 0.5 mg/day. A combined analysis of three placebo-controlled clinical studies conducted in patients with benign prostatic hyperplasia (BPH) found sustained improvements in American Urological Association- Symptom Index scores and urinary flow rate and a 57% decrease in the risk of acute urinary retention throughout the 2-year treatment period (all p < 0.001 vs placebo). Total prostate and transition zone volume were also reduced (both p < 0.001), as was the risk of BPH-related surgery (by 48%). A nonblind extension study found that dutasteride maintains efficacy for up to 4 years. Dutasteride monotherapy maintained symptom relief following combination treatment with dutasteride and tamsulosin in all patients but those with severe symptoms. Dutasteride was generally well tolerated. Impotence, reduced libido, gynaecomastia and ejaculation disorder occurred significantly more often in dutasteride than placebo recipients, but incidence was generally low. With the exception of gynaecomastia, incidence consistently decreased over time.

Publication types

  • Review

MeSH terms

  • 5-alpha Reductase Inhibitors*
  • Azasteroids / pharmacokinetics
  • Azasteroids / therapeutic use*
  • Drug Therapy, Combination
  • Dutasteride
  • Humans
  • Male
  • Prostate-Specific Antigen / drug effects
  • Prostatic Hyperplasia / drug therapy*
  • Randomized Controlled Trials as Topic

Substances

  • 5-alpha Reductase Inhibitors
  • Azasteroids
  • Prostate-Specific Antigen
  • Dutasteride