title: Safety and efficacy of 8-mg once-daily vs 4-mg twice-daily silodosin in patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia (SILVER Study): a 12-week, double-blind, randomized, parallel, multicenter study.
abstract: OBJECTIVE
  To show the noninferiority of silodosin 8-mg once-daily (QD) to 4-mg twice-daily (BID) in efficacy and safety in patients with lower urinary tract symptoms or benign prostatic hyperplasia in the Korean population.
  
  
  METHODS
  A prospective, multicenter, double-blind, randomized, comparative study was conducted. A total of 532 male patients aged ≥50 years with lower urinary tract symptoms or benign prostatic hyperplasia were included. All patients received silodosin QD or BID for 12 weeks. The primary end point was the change from baseline in total International Prostate Symptom Score (IPSS) at 12 weeks. Adverse drug reactions, vital signs, and laboratory tests were recorded.
  
  
  RESULTS
  A total of 424 patients were randomized to the silodosin QD or BID groups. These groups were not significantly different in baseline characteristics. The mean total IPSS change in QD group was not inferior to that in BID group (-6.70 and -6.94, respectively; 95% confidence interval, -0.88 to 1.36). The QD and BID groups did not significantly differ in the following: percentages of patients with ≥25% (63.41% and 67.82%, respectively; P = .349) or ≥4-point improvement in total IPSS (65.85% and 69.31%, respectively; P = .457), maximum urinary flow rate improvement ≥30% (47.32% and 40.59%, respectively; P = .172), changes in IPSS voiding subscore (-4.42 ± 4.93 and -4.65 ± 4.77; P = .641), IPSS storage subscore (-2.05 ± 3.07 and -2.52 ± 2.97; P = .117), quality of life (-1.19 ± 1.49 and -1.40 ± 1.42; P = .136), maximum urinary flow rate (3.55 ± 5.93 and 3.74 ± 6.79 mL/s; P = .768), International Continence Society male questionnaire score, Patient Goal Achievement Score, or Treatment Satisfaction Question. The 2 groups had similar frequencies of adverse drug reactions.
  
  
  CONCLUSIONS
  QD administration of silodosin was not inferior to BID in efficacy. The 2 groups had similar adverse drug reaction profiles.
authors: Department of Urology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.
authors: Myung-Soo
authors: MS
authors: Choo
authors: Department of Urology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.
authors: Miho
authors: M
authors: Song
authors: Department of Urology, Yonsei University College of Medicine, Severance Hospital, Seoul, Korea.
authors: Jang Hwan
authors: JH
authors: Kim
authors: Department of Urology, Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, Korea.
authors: Kyu-Sung
authors: KS
authors: Lee
authors: Department of Urology, The Catholic University of Korea, Bucheon St. Mary's Hospital, Bucheon, Korea.
authors: Joon Chul
authors: JC
authors: Kim
authors: Department of Urology, The Catholic University of Korea College of Medicine, Seoul, Korea.
authors: Sae Woong
authors: SW
authors: Kim
authors: Department of Urology, Konkuk University Chungju Hospital, Konkuk University School of Medicine, Chungju, Korea.
authors: Sang-Kuk
authors: SK
authors: Yang
authors: Department of Urology, Korea University College of Medicine, Seoul, Korea.
authors: Jeong Gu
authors: JG
authors: Lee
authors: Department of Urology, Pusan National University Hospital, Busan, Korea.
authors: Jeong Zoo
authors: JZ
authors: Lee
authors: Department of Urology, Eulji University School of Medicine, Eulji University Hospital, Daejeon, Korea.
authors: Dae Kyung
authors: DK
authors: Kim
authors: Department of Urology, Inha University College of Medicine, Incheon, Korea.
authors: Won Hee
authors: WH
authors: Park
authors: Department of Urology, Chung-Ang University College of Medicine, Seoul, Korea.
authors: Kyung Do
authors: KD
authors: Kim
authors: Department of Urology, Chungnam National University School of Medicine, Daejeon, Korea.
authors: Yong Gil
authors: YG
authors: Na
authors: Department of Urology, Chonnam National University Medical School, Gwangju, Korea.
authors: Dong Deuk
authors: DD
authors: Kwon
authors: Department of Urology, Seoul National University College of Medicine, Seoul, Korea. Electronic address: jspaick@snu.ac.kr.
authors: Jae-Seung
authors: JS
authors: Paick
mesh_terms: D000368:Aged; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D006801:Humans; D007211:Indoles / Q000008:administration & dosage* / Q000627:therapeutic use; D059411:Lower Urinary Tract Symptoms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011470:Prostatic Hyperplasia / Q000188:drug therapy*; D056910:Republic of Korea; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014554:Urination / Q000187:drug effects; D064804:Urological Agents / Q000008:administration & dosage* / Q000627:therapeutic use
chemical_list: D007211:Indoles; D064804:Urological Agents; C095285:silodosin