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Urology. 2014 Apr;83(4):875-81. doi: 10.1016/j.urology.2013.11.013. Epub 2014 Feb 12.

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.

Author information

  • 1Department of Urology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.
  • 2Department of Urology, Yonsei University College of Medicine, Severance Hospital, Seoul, Korea.
  • 3Department of Urology, Sungkyunkwan University School of Medicine, Samsung Medical Center, Seoul, Korea.
  • 4Department of Urology, The Catholic University of Korea, Bucheon St. Mary's Hospital, Bucheon, Korea.
  • 5Department of Urology, The Catholic University of Korea College of Medicine, Seoul, Korea.
  • 6Department of Urology, Konkuk University Chungju Hospital, Konkuk University School of Medicine, Chungju, Korea.
  • 7Department of Urology, Korea University College of Medicine, Seoul, Korea.
  • 8Department of Urology, Pusan National University Hospital, Busan, Korea.
  • 9Department of Urology, Eulji University School of Medicine, Eulji University Hospital, Daejeon, Korea.
  • 10Department of Urology, Inha University College of Medicine, Incheon, Korea.
  • 11Department of Urology, Chung-Ang University College of Medicine, Seoul, Korea.
  • 12Department of Urology, Chungnam National University School of Medicine, Daejeon, Korea.
  • 13Department of Urology, Chonnam National University Medical School, Gwangju, Korea.
  • 14Department of Urology, Seoul National University College of Medicine, Seoul, Korea. Electronic address: jspaick@snu.ac.kr.

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.

CONCLUSION:

QD administration of silodosin was not inferior to BID in efficacy. The 2 groups had similar adverse drug reaction profiles.

Copyright © 2014 Elsevier Inc. All rights reserved.

PMID:
24529580
[PubMed - indexed for MEDLINE]
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