Safety and efficacy of sildosin for the treatment of benign prostatic hyperplasia / Ahmed Mansour Abdelkader ; Supervised Sherif Abdelrahman , Mostafa Abdelmohsen , Ashraf Emran

Thesis (M.Sc.) - Cairo University - Faculty of Medicine - Department of Urology

Background: Ü1 adrenergic receptor antagonists are commonly used as the first-line treatments for LUTS associated with BPH. Silodosin is a novel Ü1-adrenergic receptor antagonist whose affinity for the Ü1A-adrenergic receptor is 162 times higher than that for the Ü1B-adrenergic receptor, and 55 times higher than that for the Ü1D-adrenergic receptor, therefore, silodosin does not increase the incidence of blood pressure-related side effects, which are mainly result from the inhibition of the Ü1B-adrenergic receptor. To test the hypothesis that the efficacy of silodosin( in dose of 8 mg once daily) would not be inferior to tamsulosin (in dose of 0.4 mg once daily) in treating patients with LUTS associated with BPH, with lesser cardiovascular side effects (as judged by the minimal changes of blood pressure and heart rate after treatment ). A randomized, double-blind, placebo- and active-controlled, parallel-group study assessed men {u2265}50 yrs. of age with LUTS/BPH, international prostate symptom Score (IPSS) {u2265}13, post voiding residue (PVR) {u2264}150 ml and maximum urinary flow rate (Qmax) between 4 and 15 ml/s. Following screening, subjects completed a 24-wk silodosin 8 mg once daily, tamsulosin 0.4 mg once daily and placebo. Outcomes were assessed by change from baseline in IPSS, quality of life (QoL), Qmax, PVR, systolic blood pressure (S.BP), diastolic blood pressure (D.BP) and heart rate (HR) to endpoint of the study. Responders to the treatments on the basis of IPSS decrease of {u2265}25% and Qmax increase of {u2265}30% were calculated

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