A Comprehensive Review of the Clinical Evidence on the Efficacy, Effectiveness, and Safety of Silodosin for the Treatment of Benign Prostatic Hyperplasia.

Silodosin, a highly selective α1A-adrenoceptor blocker, is an effective treatment for lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH). Despite its growing use, there remains a lack of comprehensive evidence evaluating the efficacy/effectiveness and safety of silodosin in BPH patients, especially in patients with comorbidities. This review aimed to synthesize recent clinical evidence on the efficacy/effectiveness and overall safety of silodosin in treating BPH. The PubMed literature search identified 23 articles (clinical trials: n = 18; observational studies: n = 5) published between 2014-2024 for inclusion. Silodosin alone (n = 4) significantly improved urological outcomes and alleviated LUTS in BPH patients. In total, 19 studies examined the efficacy/effectiveness of silodosin compared with placebo (n = 2) or various pharmacological treatments (n = 17) for BPH, including other α1-adrenoceptor blockers and combination therapies. Silodosin reduced nocturia in BPH patients (n = 5). In BPH patients with comorbidities such as heart diseases, silodosin alleviated LUTS and enhanced quality of life (n = 5). Across 21 studies evaluating safety, silodosin was well-tolerated; the frequency of retrograde ejaculation/ejaculatory disorder ranged from 0.85% to 34.4%. Notably, the selective action of silodosin on α1A-adrenergic receptors was associated with minimal cardiovascular adverse events. This review demonstrated that silodosin is efficacious/effective and well-tolerated in BPH patients, including patients with cardiovascular comorbidities.