title: 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.
abstract: OBJECTIVE
  To compare the efficacy and safety of single half-dose silodosin and single full-dose tamsulosin in Japanese men with lower urinary tract symptoms secondary to benign prostatic hyperplasia (LUTS/BPH).
  
  
  METHODS
  Japanese men aged ≥50 years with LUTS/BPH and an International Prostate Symptom Score (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.
  
  
  CONCLUSIONS
  Single half-dose silodosin has a similar efficacy to full-dose tamsulosin in Japanese men with LUTS/BPH and thus, may represent an effective, safe, and affordable treatment option.
authors.affiliation: Department of Urology, Saitama Red Cross Hospital, Saitama, Japan.
authors.forename: Hideki
authors.initials: H
authors.lastname: Takeshita
authors.affiliation: Department of Urology, Saitama Red Cross Hospital, Saitama, Japan.
authors.forename: Shingo
authors.initials: S
authors.lastname: Moriyama
authors.affiliation: Department of Urology, Nishiohmiya Hospital, Saitama, Japan.
authors.forename: Yoshiaki
authors.initials: Y
authors.lastname: Arai
authors.affiliation: Department of Urology, Omiya Souai Hospital, Saitama, Japan.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Washino
authors.affiliation: Department of Urology, Omiya Souai Hospital, Saitama, Japan.
authors.forename: Kimitoshi
authors.initials: K
authors.lastname: Saito
authors.affiliation: Department of Urology, Saitama Red Cross Hospital, Saitama, Japan.
authors.forename: Koji
authors.initials: K
authors.lastname: Chiba
authors.affiliation: Department of Urology, Shuuwa General Hospital, Saitama, Japan.
authors.forename: Susumu
authors.initials: S
authors.lastname: Horiuchi
authors.affiliation: Department of Urology, Saitama Red Cross Hospital, Saitama, Japan.
authors.forename: Akira
authors.initials: A
authors.lastname: Noro
mesh_terms: D058668:Adrenergic alpha-1 Receptor Antagonists / Q000008:administration & dosage*; D000368:Aged; D018592:Cross-Over Studies; D004359:Drug Therapy, Combination; D006801:Humans; D007211:Indoles / Q000008:administration & dosage*; D059411:Lower Urinary Tract Symptoms / Q000188:drug therapy* / Q000209:etiology; D008297:Male; D011470:Prostatic Hyperplasia / Q000150:complications; D013449:Sulfonamides / Q000008:administration & dosage*; D000077409:Tamsulosin; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D058668:Adrenergic alpha-1 Receptor Antagonists; D007211:Indoles; D013449:Sulfonamides; C095285:silodosin; D000077409:Tamsulosin
keywords: adrenergic alpha-1 receptor antagonist; lower urinary tract symptoms; randomized clinical trial; silodosin; tamsulosin