TY - JOUR
T1 - A comparison of the efficacy and tolerability of tamsulosin and finasteride in patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia
AU - Rigatti, Patrizio
AU - Brausi, M.
AU - Scarpa, R. M.
AU - Porru, D.
AU - Schumacher, H.
AU - Rizzi, C. A.
PY - 2003
Y1 - 2003
N2 - 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.
AB - 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.
KW - Adrenergic alpha-antagonists
KW - Finasteride
KW - Prostatic hyperplasia
KW - Randomised controlled trial
KW - Tamsulosin
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U2 - 10.1038/sj.pcan.4500680
DO - 10.1038/sj.pcan.4500680
M3 - Article
C2 - 14663474
AN - SCOPUS:0346007949
VL - 6
SP - 315
EP - 323
JO - Prostate Cancer and Prostatic Diseases
JF - Prostate Cancer and Prostatic Diseases
SN - 1365-7852
IS - 4
ER -