1. 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.
- Author
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Kim SW, Park NC, Lee SW, Yang DY, Park JK, Moon DG, Yang SK, Lee SW, Moon KH, Ahn TY, Kim SW, Park K, Min KS, Ryu JK, Son H, Jung J, and Hyun JS
- Subjects
- Aged, Combined Modality Therapy, Double-Blind Method, Drug Therapy, Combination, Erectile Dysfunction etiology, Erectile Dysfunction physiopathology, Humans, Lower Urinary Tract Symptoms etiology, Lower Urinary Tract Symptoms physiopathology, Male, Middle Aged, Phosphodiesterase 5 Inhibitors administration & dosage, Phosphodiesterase 5 Inhibitors therapeutic use, Prostatic Hyperplasia complications, Sulfonamides adverse effects, Tadalafil adverse effects, Tamsulosin, Treatment Outcome, Urological Agents adverse effects, Erectile Dysfunction drug therapy, Lower Urinary Tract Symptoms drug therapy, Sulfonamides administration & dosage, Tadalafil administration & dosage, Urological Agents administration & dosage
- Abstract
Background: Phosphodiesterase type 5 inhibitors and α-adrenergic blocking agents (α-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 α-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. Kim SW, Park NC, Lee SW, et al. 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. J Sex Med 2017;14:1018-1027., (Copyright © 2017 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.)
- Published
- 2017
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