Efficacy and Safety of the Selective α1A-Adrenoceptor Blocker Silodosin for Severe Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia: A Prospective, Single-Open-Label, Multicenter Study in Korea
문기학, 송필현, 양대열, 박남철, 김수웅, 이성원, 김세웅, 문두건, 박종관, 안태영, 박광성,
소속 상세정보
문기학 ( Moon Ki-Hak )
Yeungnam University College of Medicine Department of Urology
송필현 ( Song Phil-Hyun )
Yeungnam University College of Medicine Department of Urology
양대열 ( Yang Dae-Yul )
Hallym University College of Medicine Department of Urology
박남철 ( Park Nam-Cheol )
Pusan National University School of Medicine Department of Urology
김수웅 ( Kim Soo-Woong )
Seoul National University College of Medicine Department of Urology
이성원 ( Lee Sung-Won )
Sungkyunkwan University School of Medicine Samsung Medical Center Department of Urology
김세웅 ( Kim Sae-Woong )
Seoul St.Mary’s Hospital Department of Urology
문두건 ( Moon Du-Geon )
Korea University Guro Hospital Department of Urology
박종관 ( Park Jong-Kwan )
Chonbuk National University Medical School Department of Urology
안태영 ( Ahn Tai-Young )
University of Ulsan College of Medicine Asan Medical Center Department of Urology
박광성 ( Park Kwang-Sung )
Chonnam National University Medical School Department of Urology
KMID : 0358320140550050335
Abstract
Purpose: To evaluate the efficacy and safety of silodosin 8 mg once daily in a 12-week treatment of subjects with severe lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH).
Materials and Methods: A total of 100 subjects from 10 urology centers in Korea were included in this study. The inclusion criteria were as follows: age ≥50 years, International Prostate Symptom Score (IPSS) ≥20, quality of life (QoL) score ≥3, urine volume ≥120 mL and maximal urinary flow rate (Qmax) <15 mL/s, and postvoid residual volume (PVR) <100 mL. We assessed the improvement of LUTS with change in IPSS, QoL score, Qmax, PVR, and adverse events at baseline and 4 and 12 weeks after treatment with silodosin 8 mg once daily.
Results: The IPSS values were 23.27±3.34, 15.89±6.26, and 13.80±6.31 at baseline, 4, and 12 weeks, respectively, with significant improvements (p<0.0001, p=0.0214, respectively). QoL scores were 4.44±0.85, 3.38±1.20, and 3.04±1.20 at baseline, 4, and 12 weeks, respectively, and the differences were statistically significant (p<0.0001). There was a significant difference in Qmax between baseline and 12 weeks (p<0.0001) but not in PVR (p=0.9404) during the clinical trial. The most frequent adverse event in this study was ejaculation failure with 13 cases. However, no subject dropped out because of ejaculation failure, and in 12 of the 13 cases it was fully resolved without further treatment.
Conclusions: Silodosin 8 mg once daily may be effective and safe in Korean patients with severe LUTS associated with BPH.
키워드
α1A-Adrenoceptor antagonis; Benign prostatic hyperplasia; Lower urinary tract symptoms; Selective; Silodosin
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