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

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.

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Acknowledgements

Boehringer Ingelheim Italy SpA sponsored the MICTUS study. We are grateful to the Ismar Healthcare NV for their support in editing of the manuscript.

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Correspondence to P Rigatti.

Appendix 1

Appendix 1

Investigators of the MICTUS study group: Table 3

Table 3 Table a1

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Rigatti, P., Brausi, M., Scarpa, R. et al. A comparison of the efficacy and tolerability of tamsulosin and finasteride in patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia. Prostate Cancer Prostatic Dis 6, 315–323 (2003). https://doi.org/10.1038/sj.pcan.4500680

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Keywords

  • prostatic hyperplasia
  • adrenergic alpha-antagonists
  • tamsulosin
  • finasteride
  • randomised controlled trial

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