A comparison of the efficacy and tolerability of tamsulosin and finasteride in patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia

Patrizio Rigatti, M. Brausi, R. M. Scarpa, D. Porru, H. Schumacher, C. A. Rizzi

Research output: Contribution to journalArticlepeer-review

Abstract

In this multicentre, double-blind study, patients with LUTS/BPH were randomised to 26 weeks with finasteride 5 mg once daily (n = 204) or tamsulosin 0.4 mg once daily (n = 199). Double-blind treatment was continued for another 26 weeks (total treatment duration: 1 y). The primary efficacy parameter was the difference in mean change in total Symptom Problem Index (SPI) from baseline to end point at week-26 in the intention-to-treat (ITT) and per protocol (PP) populations. Tamsulosin induced a greater improvement in total SPI (-5.2 points or -37%) compared to finasteride (-4.5 points or -31%) at week-26 (P = 0.055 in ITT and P = 0.032 in PP). Tamsulosin improved urinary symptoms (particularly the more bothersome storage symptoms) and flow more quickly than finasteride. The difference was statistically significant for the SPI from week-1 (reduction, respectively, -2.5 vs -1.8 points, P = 0.043) to week-18 and for Qmax from week-1 (increase, respectively, 2.3 vs 0.7 ml/s, P = 0.0007) to week-12. Both treatments were well tolerated with a comparable incidence of adverse events, including urinary retention.

Original languageEnglish
Pages (from-to)315-323
Number of pages9
JournalProstate Cancer and Prostatic Diseases
Volume6
Issue number4
DOIs
Publication statusPublished - 2003

Keywords

  • Adrenergic alpha-antagonists
  • Finasteride
  • Prostatic hyperplasia
  • Randomised controlled trial
  • Tamsulosin

ASJC Scopus subject areas

  • Oncology
  • Urology

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