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Silodosin Has a Favourable Cardiovascular Safety Profile in Men With BPH Older Than 65 Years: Presented at AGS By Beatriz Manzor Mitrzyk CHICAGO -- May 11, 2009 -- Among men with benign prostatic hypertrophy (BPH) treated with silodosin, the incidence of orthostatic hypotension was similar to placebo, irrespective of age. Silodosin also significantly improved International Prostate Symptom Scores (IPSS) from baseline, according to results reported here at the 2009 Annual Scientific Meeting of the American Geriatrics Society (AGS). Marc C. Gittelman, MD, FACS, a board-certified urologist, South Florida Medical Research, Aventura, Florida, presented the findings on May 1. Silodosin, an alpha1-adrenergic receptor antagonist, is recommended as first line for the management of BPH. Alpha-adrenergic blockers differ with regard to potential cardiovascular adverse effects (AEs), such as orthostatic hypotension, which can be problematic, especially in the elderly. Silodosin has low affinity for alpha-1B receptors, which play a role in the development of orthostatic hypotension. Using pooled data from 2 identical, randomised, placebo-controlled, double-blind trials, men with BPH symptoms were stratified according to age: 50 to 65 years (n = 508) and age >=65 years (n = 415). Most patients were Caucasian, and 90% completed the study. In patients aged 65 years and older, mean adjusted differences in IPSS including total, irritative subscore, and obstructive subscore were significantly improved in patients receiving silodosin 8 mg compared with those who received placebo. Peak urinary flow rate also was significantly improved in silodosin-treated patients (adjusted mean difference 1.0, P = .0195). Abnormal ejaculation was the most commonly reported AE in patients receiving silodosin (15%). Orthostatic hypotension occurred in 2.4% of silodosin-treated patients and in 1.9% of patients receiving placebo. Dizziness occurred in 3.4% of silodosin-treated patients and 1.0% of placebo patients. In the <65 years cohort, patients who received silodosin had improvement in urinary symptoms compared with placebo. Peak urinary flow rate was also significantly improved in silodosin-treated patients (adjusted mean difference 0.9, P = .0135). Abnormal ejaculation was the most commonly reported AE in patients receiving silodosin (38.6%). Orthostatic hypotension occurred in 1.5% of silodosin-treated patients and in 1.2% of patients receiving placebo. Dizziness occurred in 1.5% of silodosin-treated patients and 0.4% of placebo patients. Withdrawal from study was more common in silodosin-treated patients <65 years (6.2%) than in patients aged >=65 years (2.9%). Abnormal ejaculation occurred much less often in the older cohort than in the younger cohort of patients. No treatment-related cardiac events occurred during the study. Funding for this study was provided by Watson Laboratories, Inc. [Presentation title: Efficacy and Safety of Silodosin in Different Age Groups of Men With Symptoms of Benign Prostatic Hyperplasia. Abstract C29] E-mail this page to a friend or colleague! To print, use this version