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Silodosin Approved in Europe for Benign Prostatic Hyperplasia MILAN, Italy -- February 3, 2010 -- The European Commission for the medicinal products has approved silodosin (Urorec and Silodyx) for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). In 2 phase 3, placebo-controlled trials conducted in the United States and in 1 placebo- and active-controlled trial conducted in Europe, more than 800 patients received silodosin 8 mg once daily. In these studies, patients treated with silodosin had a significant decrease in BPH symptoms, both irritative (frequency, urgency, nocturia) and obstructive (hesitancy, incomplete empting, intermittency, weak stream). In addition, an improvement in the quality of life linked to urinary symptoms (measured by the International Prostate Symptom Score, IPSS) was observed with silodosin. Furthermore, in the active-controlled study conducted in Europe, silodosin 8 mg once daily was not inferior to tamsulosin 0.4 mg once daily, with an adjusted mean difference between treatments in the IPSS total score in favour of silodosin. The significant improvement in BPH symptoms was observed within the first week of treatment, and was maintained long-term. In addition, significant improvements in the maximum urine flow-rate (Qmax) were evident within a few hours after the first dose of silodosin, and were also maintained long-term. The safety of silodosin was extensively evaluated in a total of 1,600 patients. Only minimal cardiovascular side effects were observed. No changes were seen in supine blood pressure or heart rate, and the incidence of orthostatic hypotension was very low (1.2% with silodosin, vs 1.0% with placebo). Furthermore, no effects on cardiac repolarisation were observed, even at high doses of silodosin. Retrograde ejaculation due to silodosin’s selective receptor binding properties, was the most frequent adverse reaction reported. However, this did not represent a safety concern (the dropout rate due to retrograde ejaculation was very low), and is reversible upon discontinuation of the treatment. SOURCE: Recordati E-mail this page to a friend or colleague! To print, use this version