By: Jill Stein
ATLANTA, GA – Both tadalafil and tamsulosin significantly improve lower urinary tract symptoms/benign prostatic hypertrophy but only tadalafil significantly improves multiple secondary lower urinary tract symptoms/benign prostatic hypertrophy parameters, researchers said at the American Urological Association 2012 Annual Scientific Meeting.
Matthias Oelke, MD, Hannover Medical School, Hannover, Germany, and colleagues assessed the effects of tadalafil or tamsulosin 0.4 mg versus placebo on lower urinary tract symptoms/benign prostatic hypertrophy, and also on erectile dysfunction in men who were sexually active.
Improvements in lower urinary tract symptoms/benign prostatic hypertrophy with tadalafil 5 mg once daily have been demonstrated in several randomised, placebo-controlled studies, regardless of erectile dysfunction.
“Given that the alfa-blocker tamsulosin is often used as first-line treatment for lower urinary tract symptoms/benign prostatic hypertrophy, assessing the efficacy of monotherapy with either tadalafil or tamsulosin in the same trial is of particular interest,” said Dr. Oelke.
The study included 511 men aged 45 years and older who had moderate to severe lower urinary tract symptoms/benign prostatic hypertrophy (International Prostate Symptom Score ≥13 and maximum flow rate [Qmax] 4-15 mL/s) for >6 months.
After a 4-week placebo run-in period, patients were randomised to 12 weeks’ treatment with once-daily placebo, tadalafil 5 mg, or tamsulosin 0.4 mg.
The primary comparison was between tadalafil and placebo; tamsulosin was included as an active control. The study was not powered for direct comparison between active treatments.
The primary efficacy outcome was change in total International Prostate Symptom Score at endpoint (12 weeks or last measurement).
Results showed that tadalafil and tamsulosin significantly improved total International Prostate Symptom Score at endpoint (least squares mean placebo-adjusted treatment difference: tadalafil, -2.1 [P =.001]; tamsulosin, -1.5 [P =.023]) and 1- and 4-weeks, and significantly improved Benign Prostatic Hypertrophy Impact Index at 4 weeks and endpoint.
Tadalafil, but not tamsulosin, showed significant improvements versus placebo on the International Prostate Symptom Score Quality of Life index, Benign Prostatic Hypertrophy-Treatment Satisfaction Scale scores, and Patient and Clinician Global Impression of Improvement scales.
In sexually active men with erectile dysfunction, tadalafil significantly improved erectile dysfunction at endpoint compared with placebo but placebo did not have this effect. Qmax increased significantly at endpoint with both tadalafil (2.4 ml/s; P =.009) and tamsulosin (2.2 ml/s; P =.014) compared with placebo (1.2 ml/s).
Funding for this study was provided by Eli Lilly and Company.
- MFP Wire Services