Non‐inferiority of silodosin 4 mg once daily to twice daily for storage symptoms score evaluated by the International Prostate Symptom Score in Japanese patients with benign prostatic hyperplasia: A multicenter, randomized, parallel‐group study

Abstract

Abbreviations & AcronymsObjectives: To compare the effect of treatment with silodosin 4 mg once daily versus that of silodosin 4 mg twice daily on storage symptoms in Japanese patients with benign prostatic hyperplasia. Methods: A prospective, multicenter, 12-week, open-labeled study randomized a total of 268 men aged 50 years or older with benign prostatic hyperplasia and overactive bladder to silodosin 4 mg/day or 8 mg/day. Changes in the end-points of the average value of International Prostate Symptom Score, quality of life index in the International Prostate Symptom Score, Overactive Bladder Symptom Score and urodynamic parameters were evaluated. The change in the storage symptom subtotal score of the International Prostate Symptom Score was considered as the primary end-point. Results: Silodosin 4 mg/day was not inferior to silodosin 8 mg/day in regard to the primary end-point. In contrast, the efficacy of treatment with silodosin 4 mg twice daily was greater than that of 4 mg once daily, based on both the quality of life index and the Overactive Bladder Symptom Score total score. There was a discrepancy between the scores evaluated using the International Prostate Symptom Score and Overactive Bladder Symptom Score questionnaires. Conclusions: Silodosin 4 mg once daily is not inferior to silodosin 4 mg twice daily in regard to storage symptoms score evaluated by the International Prostate Symptom Score. In contrast, silodosin 4 mg twice daily is more effective on storage symptoms evaluated by the Overactive Bladder Symptom Score than silodosin 4 mg once daily.

Randomized Crossover Comparison of the Short‐Term Efficacy and Safety of Single Half‐Dose Silodosin and Tamsulosin Hydrochoride in Men With Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia

“…Third, the incidence of AEs including ejaculation disorders and low blood pressure will be minimized with the lower dose of silodosin, because AEs are usually dose‐dependent. In a recent study, the AE rate was lower in patients receiving half‐dose (4 mg) silodosin than in those receiving full‐dose (8 mg) silodosin (11.3% vs. 18.3%) …”

“…Wada et al and Matsui et al showed that single half‐dose silodosin was effective in 63–76% of patients with LUTS/BPH . In a recent large randomized study of 268 LUTS/BPH patients, Seki et al demonstrated the non‐inferiority of single half‐dose silodosin to full‐dose silodosin . Single half‐dose silodosin has several potential merits.…”

“…11,12 In a recent large randomized study of 268 LUTS/BPH patients, Seki et al demonstrated the non-inferiority of single half-dose silodosin to full-dose silodosin. 18 Single half-dose silodosin has several potential merits. First, the drug cost can be halved.…”

“…In a recent study, the AE rate was lower in patients receiving half-dose (4 mg) silodosin than in those receiving full-dose (8 mg) silodosin (11.3% vs. 18.3%). 18 Nocturia is a frequently encountered problem in men with LUTS/BPH and impairs QOL. In a previous crossover study, Miyakita et al demonstrated that full-dose silodosin led to a significantly superior improvement in nocturia compared with tamsulosin.…”

Systematic review and meta-analysis of efficacy and safety of silodosin in treatment of benign prostatic hyperplasia patients with lower urinary tract symptoms

“…Several previous meta-analysis and sympathetic reviews have been conducted but the grouping method is not detailed due to a limited number of articles [14][15][16][17] . To date, more and more researches have evaluated the difference of efficacy and safety among silodosin and other medications whereas the results are controversial [18][19][20][21][22][23][24][25][26][27][28][29][30][31][32][33][34][35] .Therefore, we decided to perform this meta-analysis through a more detailed systematic review of those accessible RCTs to distinguish silodosin's superiority and non-inferiority to placebo and other medications in males with LUTS/BPH, which can provided more dependable guidance for the clinical application of silodosin.…”