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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
Author(s) -
TAKESHITA Hideki,
MORIYAMA Shingo,
ARAI Yoshiaki,
WASHINO Satoshi,
SAITO Kimitoshi,
CHIBA Koji,
HORIUCHI Susumu,
NORO Akira
Publication year - 2016
Publication title -
luts: lower urinary tract symptoms
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.451
H-Index - 15
eISSN - 1757-5672
pISSN - 1757-5664
DOI - 10.1111/luts.12106
Subject(s) - silodosin , tamsulosin , medicine , urology , lower urinary tract symptoms , international prostate symptom score , adverse effect , nocturia , crossover study , benign prostatic hyperplasia (bph) , urinary system , hyperplasia , placebo , prostate , alternative medicine , pathology , cancer
Objective To compare the efficacy and safety of single half‐dose silodosin and single full‐dose tamsulosin in J apanese men with lower urinary tract symptoms secondary to benign prostatic hyperplasia ( LUTS / BPH ). Methods Japanese men aged ≥50 years with LUTS / BPH and an I nternational P rostate S ymptom S core ( IPSS ) of ≥8 were enrolled in the randomized crossover study and divided into silodosin‐preceding ( S‐T ) and tamsulosin‐preceding ( T‐S ) groups. The S‐T group received 4 mg silodosin once daily for 4 weeks followed by 0.2 mg tamsulosin once daily for 4 weeks. The T‐S group received the reverse treatment sequence. A washout period prior to drug crossover was not included. Subjective and objective efficacy parameters including IPSS , quality of life ( QOL ) index, uroflowmetry, and safety were compared between the two groups. Results Thirty of 34 men ( S‐T group n = 16; T‐S group n = 14) completed the study. Both drugs significantly improved all IPSS items and QOL index in the first treatment period. Subjective improvement in nocturia by silodosin was observed in both the first and crossover treatment periods. Objective improvement in maximum flow rate by silodosin was only observed in the first treatment period. Adverse events occurred more frequently with silodosin than with tamsulosin; however, none of the adverse events required treatment discontinuation. Ejaculation disorders occurred in three participants (10%) and were associated with silodosin use. Conclusion Single half‐dose silodosin has a similar efficacy to full‐dose tamsulosin in J apanese men with LUTS / BPH and thus, may represent an effective, safe, and affordable treatment option.