Abstract

COMPARATIVE EFFICACY AND SAFETY STUDY OF FINASTERIDE VERSUS DUTASTERIDE, IN ADDITION TO TADALAFIL, IN THE TREATMENT OF LOWER URINARY TRACT SYMPTOMS DUE TO BENIGN PROSTATIC HYPERPLASIA

Adarsh Rag*, Jarnail Singh Braich, Hemant Kamal

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Abstract

Background: Tadalafil is approved globally for the treatment of erectile dysfunction, the signs and symptoms of benign prostate hyperplasia with lower urinary tract symptoms (BPH-LUTS). Coadministration of tadalafil 5 mg with a 5α-reductase inhibitor, i.e., finasteride/dutasteride, leads to statistically significant improvements in total International Prostate Symptom Scores as early as 1 to 2 weeks after beginning therapy. Aim: To compare the efficacy and safety of finasteride versus dutasteride when in combination with tadalafil in the treatment of LUTS because of BPH. Methods: This was a randomised controlled trial conducted over one year in which the eligible patients were randomised in a 1:1 ratio to either of the 2 study arms: Tadalafil 5 mg plus finasteride or Tadalafil 5 mg plus dutasteride, for 8 weeks. The primary endpoint was a decrease in total International Prostate Symptom Score (IPSS-T) at 4 and 8 weeks from baseline. Secondary endpoints included (i) change in IPSS Quality of Life Index score ; (ii) change in IPSS storage sub score; (iii) change in IPSS voiding sub score; (iv) decrease in prostate volume; and (v) decrease in post-void residual volume. Results: Of the 55 patients screened, 25 were enrolled in each group, and 20 patients in each group were available for final analysis. At baseline, both groups were comparable. The tadalafil/finasteride group exhibited a statistically significantly greater reduction in IPSS-T (10.55±1.98 vs 12.3±1.38; p

Keywords: Tadalafil, finasteride, dutasteride, BPH, PDE-5 inhibitor, International Prostate Symptom Score, prostate volume, post-void residual volume.