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
DC Field | Value | Language |
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dc.contributor.author | Kim, Sae Woong | - |
dc.contributor.author | Park, Nam Cheol | - |
dc.contributor.author | Lee, Seung Wook | - |
dc.contributor.author | Yang, Dae Yul | - |
dc.contributor.author | Park, Jong Kwan | - |
dc.contributor.author | Moon, Du Geon | - |
dc.contributor.author | Yang, Sang-Kuk | - |
dc.contributor.author | Lee, Sung Won | - |
dc.contributor.author | Moon, Ki Hak | - |
dc.contributor.author | Ahn, Tai Young | - |
dc.contributor.author | Kim, Soo Woong | - |
dc.contributor.author | Park, Kwangsung | - |
dc.contributor.author | Min, Kweon Sik | - |
dc.contributor.author | Ryu, Ji-Kan | - |
dc.contributor.author | Son, Hankil | - |
dc.contributor.author | Jung, Jina | - |
dc.contributor.author | Hyun, Jae Seog | - |
dc.date.accessioned | 2021-09-03T03:25:38Z | - |
dc.date.available | 2021-09-03T03:25:38Z | - |
dc.date.created | 2021-06-16 | - |
dc.date.issued | 2017-08 | - |
dc.identifier.issn | 1743-6095 | - |
dc.identifier.uri | https://scholar.korea.ac.kr/handle/2021.sw.korea/82677 | - |
dc.description.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. | - |
dc.language | English | - |
dc.language.iso | en | - |
dc.publisher | ELSEVIER SCI LTD | - |
dc.subject | BENIGN PROSTATIC HYPERPLASIA | - |
dc.subject | PHOSPHODIESTERASE 5 INHIBITORS | - |
dc.subject | ONCE-DAILY TADALAFIL | - |
dc.subject | ALPHA-BLOCKERS | - |
dc.subject | VS. TAMSULOSIN | - |
dc.subject | MEN | - |
dc.subject | METAANALYSIS | - |
dc.subject | SECONDARY | - |
dc.subject | LUTS/BPH | - |
dc.title | 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 | - |
dc.type | Article | - |
dc.contributor.affiliatedAuthor | Moon, Du Geon | - |
dc.identifier.doi | 10.1016/j.jsxm.2017.06.006 | - |
dc.identifier.scopusid | 2-s2.0-85026550029 | - |
dc.identifier.wosid | 000407726000006 | - |
dc.identifier.bibliographicCitation | JOURNAL OF SEXUAL MEDICINE, v.14, no.8, pp.1018 - 1027 | - |
dc.relation.isPartOf | JOURNAL OF SEXUAL MEDICINE | - |
dc.citation.title | JOURNAL OF SEXUAL MEDICINE | - |
dc.citation.volume | 14 | - |
dc.citation.number | 8 | - |
dc.citation.startPage | 1018 | - |
dc.citation.endPage | 1027 | - |
dc.type.rims | ART | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
dc.relation.journalResearchArea | Urology & Nephrology | - |
dc.relation.journalWebOfScienceCategory | Urology & Nephrology | - |
dc.subject.keywordPlus | BENIGN PROSTATIC HYPERPLASIA | - |
dc.subject.keywordPlus | PHOSPHODIESTERASE 5 INHIBITORS | - |
dc.subject.keywordPlus | ONCE-DAILY TADALAFIL | - |
dc.subject.keywordPlus | ALPHA-BLOCKERS | - |
dc.subject.keywordPlus | VS. TAMSULOSIN | - |
dc.subject.keywordPlus | MEN | - |
dc.subject.keywordPlus | METAANALYSIS | - |
dc.subject.keywordPlus | SECONDARY | - |
dc.subject.keywordPlus | LUTS/BPH | - |
dc.subject.keywordAuthor | Benign Prostatic Hyperplasia | - |
dc.subject.keywordAuthor | Lower Urinary Tract Symptoms | - |
dc.subject.keywordAuthor | Erectile Dysfunction | - |
dc.subject.keywordAuthor | Fixed-Dose Combination | - |
dc.subject.keywordAuthor | Tadalafil | - |
dc.subject.keywordAuthor | Tamsulosin | - |
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