PURPOSE: Medical treatment for men with lower urinary tract symptoms and prostatic enlargement secondary to benign prostatic hyperplasia is 5α-reductase inhibitor monotherapy or coadministration with an α-blocker.
We assessed the effects of tadalafil 5 mg coadministered with finasteride 5 mg during 26 weeks on lower urinary tract symptoms and sexual symptoms.
MATERIALS AND METHODS: We conducted an international, randomized, double-blind, parallel study of men (45 years old or older, 5α-reductase inhibitor naïve, I-PSS [International Prostate Symptom Score] 13 or greater, prostate volume 30 ml or greater) treated with placebo/finasteride coadministration (350) or tadalafil/finasteride coadministration (345) for 26 weeks. Benign prostatic hyperplasia-lower urinary tract symptoms changes were assessed using the I-PSS. Erectile dysfunction improvements were assessed via IIEF-EF (International Index of Erectile Function-erectile function domain) in sexually active men with erectile dysfunction. Safety was assessed in terms of adverse events.
RESULTS: Least squares mean changes from baseline in I-PSS after 4, 12 and 26 weeks of tadalafil/finasteride coadministration were -4.0, -5.2 and -5.5. Corresponding values for placebo/finasteride coadministration were -2.3, -3.8 and -4.5 (p ≤ 0.022 at all visits favoring tadalafil/finasteride coadministration). I-PSS subscores (storage and voiding) and quality of life index were also numerically improved with tadalafil/finasteride coadministration Least squares mean changes from baseline in IIEF-EF with tadalafil/finasteride coadministration were 3.7 after 4 weeks, and 4.7 after 12 and 26 weeks. Corresponding values for placebo/finasteride coadministration were -1.1, 0.6 and -0.0 (p < 0.001 at all visits favoring tadalafil/finasteride coadministration). Tadalafil/finasteride coadministration was well tolerated and most adverse events were mild/moderate.
CONCLUSIONS: The coadministration of tadalafil/finasteride provides early improvement in lower urinary tract symptoms in men with benign prostatic hyperplasia and prostatic enlargement. Tadalafil/finasteride coadministration also improves erectile function in men who have comorbid erectile dysfunction.
Written by:
Casabé A, Roehrborn CG, Da Pozzo LF, Zepeda S, Henderson RJ, Sorsaburu S, Henneges C, Wong DG, Viktrup L. Are you the author?
Instituto Médico Especializado, Buenos Aires, Argentina.
Reference: J Urol. 2013 Oct 2. pii: S0022-5347(13)05558-4.
doi: 10.1016/j.juro.2013.09.059
PubMed Abstract
PMID: 24096118
