For the study, led by Christopher R. Chapple, MD, of Royal Hallamshire Hospital in Sheffield, researchers focused on efficacy and safety of the highly-selective agent silodosin, for the treatment of moderate to severe LUTS due to BPH.
Dr. Chapple and colleagues studied 955 men with suspected BPH who were randomly assigned to a 12-week treatment with silodosin 8 mg, tamsulosin 0.4 mg, or placebo, administered once daily. Patient data were obtained using the International Prostate Symptom Score (IPSS) questionnaire and storage and voiding subscores. In addition, researchers measured quality of life (QoL) due to urinary symptoms, and urine maximum flow rate (Qmax).
Researchers observed a statistically significant and potentially clinically relevant difference versus placebo in the IPSS total score, in the storage and voiding subscores, and in QoL due to urinary symptoms. Specifically, responder rates according to total IPSS were significantly higher with silodosin (66.8%) and tamsulosin (65.4%) than with placebo (50.8%). In addition, active treatment was superior to placebo in the IPSS storage and voiding subscore analyses, as well as in QoL due to urinary symptoms.
Further investigation revealed that a major advantage of silodosin was its lack of cardiovascular side effects. “It has no clinically relevant effect on blood pressure when measured either in the supine position or during osthostatic testing,” the authors explained. “This is important because most patients treated for LUTS associated with BPH are elderly and often on concomitant antihypertensive therapy or taking agents such as phosphodiesterase inhibitors.”
The study’s findings were published online ahead of print in European Urology.