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 |
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| Affiliation: | 1. Department of Anesthesiology and Pain Medicine, Korea University Guro Hospital, Seoul, Republic of Korea;2. Department of Anesthesiology and Pain Medicine, Kyung Hee Medical Center, Seoul, Republic of Korea;1. Health Screening and Promotion Center, Seoul National University Bundang Hospital, Gyeonggi-do, Republic of Korea;2. Department of Family Medicine, Seoul National University Bundang Hospital, Gyeonggi-do, Republic of Korea;3. Department of Family Medicine, Samsung Medical Center, Seoul, Republic of Korea;4. Department of Family Medicine, Seoul National University Hospital, Seoul, Republic of Korea;5. Department of Neurology, Hallym University Sacred Heart Hospital, Anyang, Republic of Korea;6. Department of Neurology, Seoul National University-Seoul Municipal Government Boramae Medical Center, Seoul, Republic of Korea;7. Department of Neurology, Seoul National University College of Medicine, Seoul, Republic of Korea;8. Department of Family Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea;1. Asan Medical Center, South Korea;2. Korea University Anam Hospital, South Korea;3. Ewaha Womans University Mokdong Hospital, South Korea;4. Samsung Medical Center, Sungkyunkwan University, South Korea;5. Seoul National University Hospital, South Korea;6. Seoul National University Boramae Hospital, South Korea;7. Dongguk University Ilsan Hospital, South Korea;8. Kangdong Sacred Heart Hospital, South Korea;9. Inha University Hospital, South Korea;10. Chung-Ang University Hospital, South Korea;11. Kyung Hae University Hospital, South Korea;12. Konkuk University Medical Center, South Korea;13. Severance Hospital, South Korea;14. The Catholic University of Korea, St. Mary''s Hospital, South Korea;15. Inje University Sanggye Paik Hospital, South Korea;16. Ajou University Hospital, South Korea;17. Yonsei University Wonju Serverance Christian Hospital, South Korea;18. Myongji Hospital, South Korea;19. Seoul Medical Center, South Korea;20. Inje University Pusan Paik Hospital, South Korea;21. National Medical Center, South Korea;22. Dong-A University Medical Center, South Korea;23. Gyeongsang National University Hospital, South Korea;24. Ulsan University Hospital, South Korea;25. KeiMyung University Dongsan Medical Center, South Korea;26. Yeungnam University Hospital, South Korea;27. Kyungbuk National University Hospital, South Korea;28. Chungnam National University Hospital, South Korea;29. Chonbuk National University Hospital, South Korea;30. Chonnam National University Hospital, South Korea;31. Eulji University Hospital, South Korea;32. Wonkwang University Hospital, South Korea;33. Chosun University Hospital, South Korea;34. Kangbuk Samsung Hospital, South Korea;35. Kangnam Sacred Heart Hospital, South Korea;36. National Health Insurance Corporation Ilsan Hospital, South Korea;37. Catholic University of Daegu, South Korea;38. Daejeon St. Mary''s Hospital, South Korea;39. Gachon University Gil Hospital, South Korea;40. Kosin University Gospel Hospital, South Korea;41. Pusan National University Hospital, South Korea;42. Bundang CHA Medical Center, South Korea;43. Hanyang University Guri Hospital, South Korea;44. Changwon Fatima Hospital, South Korea;2. Stroke Center and Department of Neurology, College of Medicine, Ewha Womans University, Seoul, South Korea;3. Department of Biostatistics, College of Medicine, Korea University, Seoul, South Korea;4. Stroke Center and Department of Neurology, Asan Medical Center, University of Ulsan, Seoul, South Korea;6. Department of Neurology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea |
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| Abstract: | BackgroundPhosphodiesterase 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).AimsTo 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.MethodsA 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.OutcomesThe 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.ResultsThe 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 ImplicationsThe 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 LimitationsThe 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.ConclusionThe 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. |
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| Keywords: | Benign Prostatic Hyperplasia Lower Urinary Tract Symptoms Erectile Dysfunction Fixed-Dose Combination Tadalafil Tamsulosin |
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