Detailed Information

Cited 36 time in webofscience Cited 36 time in scopus
Metadata Downloads

Efficacy and Safety of a Fixed-Dose Combination Therapy of Tamsulosin and Tadalafil for Patients With Lower Urinary Tract Symptoms and Erectile Dysfunction: Results of a Randomized, Double-Blinded, Active-Controlled Trial

Authors
Kim, Sae WoongPark, Nam CheolLee, Seung WookYang, Dae YulPark, Jong KwanMoon, Du GeonYang, Sang-KukLee, Sung WonMoon, Ki HakAhn, Tai YoungKim, Soo WoongPark, KwangsungMin, Kweon SikRyu, Ji-KanSon, HankilJung, JinaHyun, Jae Seog
Issue Date
Aug-2017
Publisher
ELSEVIER SCI LTD
Keywords
Benign Prostatic Hyperplasia; Lower Urinary Tract Symptoms; Erectile Dysfunction; Fixed-Dose Combination; Tadalafil; Tamsulosin
Citation
JOURNAL OF SEXUAL MEDICINE, v.14, no.8, pp 1018 - 1027
Pages
10
Indexed
SCIE
SCOPUS
Journal Title
JOURNAL OF SEXUAL MEDICINE
Volume
14
Number
8
Start Page
1018
End Page
1027
URI
https://scholarworks.korea.ac.kr/kumedicine/handle/2020.sw.kumedicine/4765
DOI
10.1016/j.jsxm.2017.06.006
ISSN
1743-6095
1743-6109
Abstract
Background: Phosphodiesterase type 5 inhibitors and alpha-adrenergic blocking agents (alpha-blockers) are widely used for the treatment of erectile dysfunction (ED) and lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH). Aims: To assess the efficacy and safety of fixed-dose combinations (FDCs) of tamsulosin and tadalafil compared with tadalafil monotherapy in patients with comorbid BPH-associated LUTS and ED. Methods: A randomized, double-blinded, active-controlled trial was conducted of 510 men with BPH-associated LUTS and ED. Patients were treated with FDCs of tamsulosin 0.4 mg plus tadalafil 5 mg (FDC 0.4/5 mg), tamsulosin 0.2 mg plus tadalafil 5 mg (FDC 0.2/5 mg), or tadalafil 5 mg for a 12-week treatment period. For a subsequent 12-week extension period, the patients were administered FDC 0.4/5 mg. Outcomes: The primary outcomes were changes from baseline in total International Prostate Symptom Score (IPSS) and International Index of Erectile Function erectile function domain (IIEF-EF) score at week 12 to prove superiority and non-inferiority of FDCs compared with tadalafil 5 mg. The safety assessments were adverse reactions, laboratory test results, and vital signs at week 24. Results: The mean changes in total IPSS and IIEF-EF scores were -9.46 and 9.17 for FDC 0.4/5 mg and -8.14 and 9.49 for tadalafil 5 mg, respectively, which indicated superiority in LUTS improvement (P =.0320) and non-inferiority in ED treatment with FDC 0.4/5 mg compared with tadalafil 5 mg. However, the results from FDC 0.2/5 mg failed to demonstrate superiority in LUTS improvement. No clinically significant adverse events regarding the investigational products were observed during the 24-week period. Clinical Implications: The FDC 0.4/5 mg is the first combined formulation of an alpha-blocker and a phosphodiesterase type 5 inhibitor that offers benefits in patient compliance and as add-on therapy in patients with comorbid BPH-associated LUTS and ED. Strengths and Limitations: The study clearly demonstrated the advantage of FDC 0.4/5 mg. The main advantage of FDC 0.4/5 mg was the enhanced efficacy on BPH-associated LUTS comorbidity with ED, the lower incidence of side effects, and the simplification and convenience of therapy, which led to better overall patient compliance. However, the lack of a tamsulosin monotherapy control group was a limitation of this study. Conclusion: The FDC 0.4/5 mg therapy was safe, well tolerated, and efficacious, indicating that combination therapy could provide clinical benefits for patients with BPH-associated LUTS complaints and ameliorate the comorbidity of ED. Copyright (C) 2017, International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.
Files in This Item
There are no files associated with this item.
Appears in
Collections
2. Clinical Science > Department of Urology > 1. Journal Articles

qrcode

Items in ScholarWorks are protected by copyright, with all rights reserved, unless otherwise indicated.

Related Researcher

Researcher Moon, Du Geon photo

Moon, Du Geon
Guro Hospital (Department of Urology, Guro Hospital)
Read more

Altmetrics

Total Views & Downloads

BROWSE