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• W2103256339 abstract "No AccessJournal of UrologyAdult urology1 Sep 2006Dutasteride Improves Objective and Subjective Disease Measures in Men With Benign Prostatic Hyperplasia and Modest or Severe Prostate Enlargement Marc Gittelman, Joe Ramsdell, Jay Young, and Tom McNicholas Marc GittelmanMarc Gittelman South Florida Medical Research, Aventura, Florida Financial interest and/or other relationship with GlaxoSmithKline. More articles by this author , Joe RamsdellJoe Ramsdell University of California-San Diego Clinical Trials Center,La Jolla More articles by this author , Jay YoungJay Young South Orange County Medical Research Center, Laguna Woods, California Financial interest and/or other relationship with Pfizer, Lilly-ICOS, GlaxoSmithKline, Bayer, Novartis and Polatin. More articles by this author , and Tom McNicholasTom McNicholas Lister Hospital, Stevenage,United Kingdom Financial interest and/or other relationship with GlaxoSmithKline. More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2006.04.032AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract Purpose: We determined whether the effect of dutasteride for benign prostatic hyperplasia is influenced by baseline prostate volume using data from 3 phase III clinical trials. Materials and Methods: Patients randomized to dutasteride or placebo in the double-blind portion of the phase III studies were eligible to receive 0.5 mg dutasteride daily in a 2-year open label extension in dutasteride/dutasteride and placebo/dutasteride groups. Patients were prospectively stratified according to baseline prostate volume 30 to less than 40 and 40 cc or greater. Results: In patients treated with dutasteride throughout the study (dutasteride/dutasteride group) the mean reduction in prostate volume from baseline to month 48 was 30.3% in those with a baseline prostate volume of 30 to less than 40 cc and 26.2% in those with a prostate volume of 40 cc or greater. Mean improvements in peak urinary flow from baseline to month 48 were 2.7 ml per second regardless of baseline prostate volume. Improvements in the American Urological Association symptom index score were 6.3 in men with a prostate volume of 30 to less than 40 cc and 6.5 in those with a prostate volume of 40 cc or greater. No significant relationships between treatment effect and baseline prostate volume were observed for these parameters. In dutasteride/dutasteride treated patients the risk of acute urinary retention was decreased by 60% in those with a prostate volume of 30 to less than 40 cc and 55% in those with a prostate volume of 40 cc or greater vs values in placebo/dutasteride treated patients (p = 0.036 and <0.001, respectively). The corresponding values for benign prostatic hyperplasia related surgery were 27% and 48% (p = 0.35 and <0.001, respectively). Conclusions: This analysis demonstrates that dutasteride significantly improves objective (prostate volume and peak urinary flow) and subjective (symptom scores) measures even in patients with only a slightly enlarged prostate (30 to less than 40 cc). The risks of acute urinary retention and benign prostatic hyperplasia related surgery were decreased regardless of baseline prostate volume. References 1 : The development of human benign prostatic hyperplasia with age. J Urol1984; 132: 474. 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Google Scholar 14 : Marked suppression of dihydrotestosterone in men with benign prostatic hyperplasia by dutasteride, a dual 5 alpha-reductase inhibitor. J Clin Endocrinol Metab2004; 89: 2179. Google Scholar 15 : Dutasteride, a novel dual 5alpha-reductase inhibitor, reduces serum DHT to a greater extent than finasteride and achieves finasteride maximal reduction in a larger proportion of patients. : 2003. Presented at Congress of the European Association of Urology, Madrid, Spain, March. Google Scholar 16 : Long-term sustained improvement in symptoms of benign prostatic hyperplasia with the dual 5alpha-reductase inhibitor dutasteride: results of 4-year studies. BJU Int2005; 96: 572. Google Scholar 17 : Serum prostate-specific antigen and prostate volume predict long-term changes in symptoms and flow rate: results of a four-year, randomized trial comparing finasteride versus placebo. Urology1999; 54: 662. Google Scholar 18 : Improvement of pressure flow parameters with finasteride is greater in men with large prostates. J Urol1999; 161: 1513. Link, Google Scholar 19 : Long-term effects of finasteride in patients with benign prostatic hyperplasia: a double-blind, placebo-controlled, multicenter study. Urology1998; 51: 677. Google Scholar 20 : The efficacy of terazosin, finasteride, or both in benign prostatic hyperplasia. N Engl J Med1996; 335: 533. Google Scholar 21 : Efficacy of finasteride is maintained in patients with benign prostatic hyperplasia treated for 5 years. Urology1999; 53: 690. Google Scholar 22 : Long-term 6-year experience with finasteride in patients with benign prostatic hyperplasia. Urology2003; 61: 791. Google Scholar 23 : Long-term (7 to 8-year) experience with finasteride in men with benign prostatic hyperplasia. Urology2002; 60: 1040. Google Scholar 24 : Prostate volume and serum prostate-specific antigen as predictors of acute urinary retention. Eur Urol2000; 38: 563. Google Scholar 25 : Prostate volume and prostate-specific antigen in the absence of prostate cancer: a review of the relationship and prediction of long-term outcomes. Prostate2001; 49: 208. Google Scholar © 2006 by American Urological AssociationFiguresReferencesRelatedDetails Volume 176Issue 3September 2006Page: 1045-1050 Advertisement Copyright & Permissions© 2006 by American Urological AssociationKeywordsprostatedutasterideprostatic hyperplasiaurination disordersMetricsAuthor Information Marc Gittelman South Florida Medical Research, Aventura, Florida Financial interest and/or other relationship with GlaxoSmithKline. More articles by this author Joe Ramsdell University of California-San Diego Clinical Trials Center,La Jolla More articles by this author Jay Young South Orange County Medical Research Center, Laguna Woods, California Financial interest and/or other relationship with Pfizer, Lilly-ICOS, GlaxoSmithKline, Bayer, Novartis and Polatin. More articles by this author Tom McNicholas Lister Hospital, Stevenage,United Kingdom Financial interest and/or other relationship with GlaxoSmithKline. More articles by this author Expand All Advertisement PDF downloadLoading ..." @default.
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• W2103256339 title "Dutasteride Improves Objective and Subjective Disease Measures in Men With Benign Prostatic Hyperplasia and Modest or Severe Prostate Enlargement" @default.
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