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
이효석, 김세웅, 오승준, 주명수, 이규성,
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이효석 ( Lee Hyo-Serk )
Sungkyunkwan University School of Medicine Department of Urology
김세웅 ( Kim Sae-Woong )
Catholic University College of Medicine Department of Urology
오승준 ( Oh Seung-June )
Seoul National University Hospital Department of Urology
주명수 ( Choo Myung-Soo )
University of Ulsan College of Medicine Department of Urology
이규성 ( Lee Kyu-Sung )
Sungkyunkwan University School of Medicine Department of Urology
KMID : 0358320120530030178
Abstract
Purpose: 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).
Materials and 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.
키워드
Drugs; generic; Prostatic hyperplasia; Tamsulosin
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