Efficacy and safety of standard dose triple combination of telmisartan 80 mg/amlodipine 5 mg/chlorthalidone 25 mg in primary hypertension: A randomized,double-blind,active-controlled,multicenter phase 3 trial |
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| Authors: | Eun Joo Cho MD PhD Moo Hyun Kim MD PhD Young-Hak Kim MD PhD Kiyuk Chang MD PhD Dong-Ju Choi MD PhD Woong Chol Kang MD PhD Jinho Shin MD PhD Seong Hwan Kim MD PhD Namho Lee MD PhD Jang Won Son MD PhD Joon-Hyung Doh MD PhD Woo-Shik Kim MD PhD Soon Jun Hong MD PhD Moo-Yong Rhee MD PhD Youngkeun Ahn MD PhD Sang-Wook Lim MD PhD Seung Pyo Hong MD PhD So-Yeon Choi MD PhD Min Su Hyon MD PhD Jin-Yong Hwang MD PhD Kihwan Kwon MD PhD Kwang Soo Cha MD PhD Sang-Hyun Ihm MD PhD Jae-Hwan Lee MD PhD Byung-Su Yoo MD PhD Hyo-Soo Kim MD PhD |
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| Affiliation: | 1. Division of Cardiology, Department of Internal Medicine, Yeouido St. Mary's Hospital, Catholic University College of Medicine, Seoul, South Korea;2. Division of Cardiology, Department of Internal Medicine, Dong-A University Hospital, Dong-A University College of Medicine, Busan, South Korea;3. Division of Cardiology, Department of Internal Medicine, Asan Medical Center, University of Ulsan, Seoul, South Korea;4. Division of Cardiology, Department of Internal Medicine, Seoul St. Mary's Hospital, Catholic University College of Medicine, Seoul, South Korea;5. Division of Cardiology, Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, South Korea;6. Division of Cardiology, Department of Internal Medicine, Gil Hospital, Gachon University College of Medicine, Incheon, South Korea;7. Division of Cardiology, Department of Internal Medicine, Hanyang University Hospital, Hanyang University College of Medicine, Seoul, South Korea;8. Division of Cardiology, Department of Internal Medicine, Korea University Ansan Hospital, Korea University College of Medicine, Ansan, South Korea;9. Division of Cardiology, Department of Internal Medicine, Kangnam Sacred Heart Hospital, Hallym University College of Medicine, Seoul, South Korea;10. Division of Cardiology, Department of Internal Medicine, Yeungnam University Hospital, Yeungnam University College of Medicine, Daegu, South Korea;11. Division of Cardiology, Department of Internal Medicine, Inje University Ilsan Paik Hospital, Inje University College of Medicine, Goyang, South Korea;12. Division of Cardiology, Department of Internal Medicine, Kyung Hee University Hospital, Kyung Hee University College of Medicine, Seoul, South Korea;13. Division of Cardiology, Department of Internal Medicine, Korea University Anam Hospital, Korea University College of Medicine, Seoul, South Korea;14. Division of Cardiology, Department of Internal Medicine, Dongguk University Ilsan Hospital, Dongguk University College of Medicine, Goyang, South Korea;15. Division of Cardiology, Department of Internal Medicine, Chonnam National University Hospital, Chonnam National University College of Medicine, Gwangju, South Korea;16. Division of Cardiology, Department of Internal Medicine, CAH Bundang Medical Center, CHA University College of Medicine, Seongnam, South Korea;17. Division of Cardiology, Department of Internal Medicine, Daegu Catholic University Hospital, Daegu Catholic University College of Medicine, Daegu, South Korea;18. Division of Cardiology, Department of Internal Medicine, Ajou University Hospital, Ajou University College of Medicine, Suwon, South Korea;19. Division of Cardiology, Department of Internal Medicine, Soonchunhyang University Seoul Hospital, Soonchunhyang University College of Medicine, Seoul, South Korea;20. Division of Cardiology, Department of Internal Medicine, Gyeongsang National University Hospital, Gyeongsang National University College of Medicine, Jinju, South Korea;21. Division of Cardiology, Department of Internal Medicine, Ewha Womans University Mokdong Hospital, Ewha Womans University College of Medicine, Seoul, South Korea;22. Division of Cardiology, Department of Internal Medicine, Pusan National University Hospital, Pusan National University College of Medicine, Busan, South Korea;23. Division of Cardiology, Department of Internal Medicine, Bucheon St. Mary's Hospital, Catholic University College of Medicine, Bucheon, South Korea;24. Division of Cardiology, Department of Internal Medicine, Chungnam National University Hospital, Chungnam National University College of Medicine, Daejeon, South Korea;25. Division of Cardiology, Department of Internal Medicine, Wonju Severance Christian Hospital, Yonsei University Wonju College of Medicine, Wonju, South Korea;26. Division of Cardiology, Department of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, South Korea |
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| Abstract: | The authors evaluated the efficacy, safety, and characteristics of patients who respond well to standard dose triple combination therapy including chlorthalidone 25 mg with telmisartan 80 mg plus amlodipine 5 mg in hypertensive patients. This is a multicenter, double-blind, active-controlled, phase 3, randomized trial. Patients are randomized to triple combination (telmisartan 40 mg/amlodipine 5 mg/chlorthalidone 12.5 mg, TEL/AML/CHTD group) or dual combination (telmisartan 40 mg/amlodipine 5 mg, TEL/AML group) treatment and then dose up titration to TEL 80/AML5/CHTD25mg and TEL80/AML5, respectively. The primary endpoint is the change of mean sitting systolic blood pressure (MSSBP) at week 8. A Target BP achievement rate, a response rate, and the safety endpoints are also evaluated. Total 374 patients (mean age = 60.9 ± 10.7 years, male = 78.3%) were randomized to the study. The baseline MSSBPs/diastolic BPs were 149.9 ± 12.2/88.5 ± 10.4 mm Hg. After 8 weeks treatment, the change of MSSBPs at week 8 are −19.1 ± 14.9 mm Hg (TEL/AML/CHTD) and −11.4 ± 14.7 mm Hg (TEL/AML) (p < .0001). The achievement rates of target BP (53.8% vs. 37.8%, p = .0017) and responder rate (54.8% vs. 35.6%, p = .0001) at week 8 were significantly higher in TEL/AML/CHTD. There are no serious adverse event and no one discontinued medication due to adverse event. Among the TEL 80/AML5/CHTD25mg treatment group, patients of female or age ≥ 65 years old showed higher rate of target BP achievement than relatively young male. (61.4 vs. 46.8%, p = .042) Our study showed standard dose triple combination of telmisartan 80 mg/amlodipine 5 mg/chlorthalidone 25 mg is efficacious and safe in treatment of primary hypertension. Target BP achievement with triple therapy would be facilitated in female or old age. |
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| Keywords: | amlodipine blood pressure chlorthalidone telmisartan triple combination |
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