title: Efficacy and safety of tamsulosin for treating lower urinary tract symptoms associated with benign prostatic hyperplasia: a multicenter, randomized, controlled, open-label non-inferiority study.
abstract: OBJECTIVE
  To compare the efficacy and safety of Sulosin D (PACIFICPHARMA, Korea) and Harnal D (ASTELLAS PHARMA KOREA, Korea) in treating patients with lower urinary tract symptoms associated with benign prostatic hyperplasia (BPH).
  
  
  METHODS
  This randomized, controlled, open-label, multicenter non-inferiority study was conducted at four sites in Korea. We randomly assigned 123 patients with an International Prostate Symptom Score (IPSS) ≥12 to receive either Sulosin D or Harnal D treatment for 8 weeks. The primary outcome was the mean change in IPSS from baseline to endpoint. Secondary outcomes were the mean change from baseline to endpoint in IPSS quality of life subscores, maximum uroflowmetry (Qmax), and post-voiding residuals (PVR).
  
  
  RESULTS
  In all, 123 patients were randomly assigned (60 Sulosin D and 63 Harnal D). The changes in the total IPSS from baseline in the Sulosin D- and Harnal D-treated groups were -4.97 and -4.03, respectively. There were significant decreases compared with baseline in both groups. The mean difference (Sulosin D - Harnal D) was -0.91 (with a two-sided 90% confidence interval), inferring that Sulosin D was not inferior to Harnal D. The mean changes in the IPSS subscore, Qmax, and PVR from baseline were comparable between the groups (both p>0.05). During the treatment periods, the incidence of adverse events was 23.33% and 34.92% in the Sulosin D and Harnal D groups, respectively (p=0.1580).
  
  
  CONCLUSIONS
  We demonstrate the non-inferiority of Sulosin D to Harnal D in patients with lower urinary tract symptoms associated with BPH.
authors.affiliation: Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
authors.forename: Hyo Serk
authors.initials: HS
authors.lastname: Lee
authors.forename: Sae Woong
authors.initials: SW
authors.lastname: Kim
authors.forename: Seung-June
authors.initials: SJ
authors.lastname: Oh
authors.forename: Myung-Soo
authors.initials: MS
authors.lastname: Choo
authors.forename: Kyu-Sung
authors.initials: KS
authors.lastname: Lee