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Commentary RE: “Efficacy and Safety of a Dual Inhibitor of 5-Alpha-Reductase Types 1 and 2 (Dutasteride) in Men With Benign Prostatic Hyperplasia”

  • Eric Kim
    Affiliations
    Division of Urology, Department of Surgery, Washington University School of Medicine, St. Louis, MO, USA
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  • Gerald Andriole
    Correspondence
    Address correspondence to: Gerald Andriole, M.D., Department of Surgery, Washington University School of Medicine, St. Louis, MO, USA
    Affiliations
    Division of Urology, Department of Surgery, Washington University School of Medicine, St. Louis, MO, USA
    Search for articles by this author
      This manuscript was a pooled analysis of 4325 men in 3 Phase III studies (ARIA3001, ARIA3002, ARIA3003) evaluating dutasteride as monotherapy for benign prostatic hyperplasia (BPH). Following 24 months of 0.5 mg dutasteride daily, we demonstrated significant reductions in prostate volume (−26%), in International Prostate Symptom Scores (IPSS) (−4.5 points; −21%), and improvements in urinary flow rates (+2.2 mL/s) and a 57% risk reduction of acute urinary retention and a 48% risk reduction in BPH-related surgery. Given these results and the acceptable side effect profile, dutasteride was approved by the FDA and has become a mainstay in the management of BPH.
      • McVary KT
      • Roehrborn CG
      • Avins AL
      • et al.
      Update on AUA guideline on the management of benign prostatic hyperplasia.
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      Linked Article

      • Efficacy and safety of a dual inhibitor of 5-alpha-reductase types 1 and 2 (dutasteride) in men with benign prostatic hyperplasia
        UrologyVol. 60Issue 3
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          Objectives. To study the efficacy and safety of dutasteride, a dual inhibitor of the 5-alpha-reductase isoenzymes types I and II.Methods. A total of 4325 men (2951 completed) with clinical benign prostatic hyperplasia, moderate to severe symptoms (American Urological Association-Symptom Index score of 12 points or greater), a peak flow rate of 15 mL/s or less, a prostate volume of 30 cm3 or greater (as measured by transrectal ultrasonography), and a serum prostate-specific antigen level of 1.5 to 10.0 ng/mL (inclusive) were enrolled into three identical clinical trials and randomized to 0.5 mg dutasteride daily or placebo.
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