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Comparison of efficacy and safety between third-dose triple and third-dose dual antihypertensive combination therapies in patients with hypertension.

Division of Cardiology, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University College of Medicine, Seoul, Republic of Korea. Department of Cardiology, Cardiovascular Center, Korea University Anam Hospital, Korea University College of Medicine, Seoul, Republic of Korea. Cardiovascular Center, Dongguk University Ilsan Hospital, Goyang-si, Gyeonggi, Republic of Korea. Department of Cardiology, Chonnam National University Hospital, Gwangju, Republic of Korea. Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea. Cardiology Division, Cardiac center, CHA Bundang medical center, CHA University, Seongnam, Republic of Korea. Dong-A University Hospital, Dong-A University College of Medicine, Busan, Republic of Korea. Department of Cardiology, Daegu Catholic University Medical Center, Daegu, Republic of Korea. Department of Cardiology, Seoul Medical Center, Seoul, Republic of Korea. Cardiovascular Center, Kyung Hee University Hospital at Gangdong, Seoul, Republic of Korea. Cardiovascular Center, Seoul National University Bundang Hospital, Seongnam, Republic of Korea. Division of Cardiology, Kosin University Gospel Hospital, Kosin University College of Medicine, Busan, Republic of Korea. Boramae Hospital, Seoul University College of Medicine, Seoul, Republic of Korea. Department of internal medicine, Division of Cardiology, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea. Department of Internal Medicine, Kyung Hee University Medical Center, Kyung Hee University, Seoul, Republic of Korea. Yonsei University College of Medicine and Cardiovascular Center, Yongin Severance Hospital, Yongin, Republic of Korea. Department of Cardiology, Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea. Division of Cardiology, Department of Internal Medicine, Hanyang University College of Medicine, Seoul, Republic of Korea. Division of Cardiology, Department of Internal Medicine, Ewha Womans University Seoul Hospital, Seoul, Republic of Korea. Division of Cardiology, Department of Internal Medicine, Ewha Womans University Mokdong Hospital, Seoul, Republic of Korea. Department of Internal Medicine, Korea University Guro Hospital, Seoul, Republic of Korea. Hanmi Pharm.Co.,Ltd., Songpa-gu, Seoul, Republic of Korea.

Journal of clinical hypertension (Greenwich, Conn.). 2023;(5):429-439
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Abstract

We compared the efficacy and safety of third-standard-dose triple and third-standard-dose dual antihypertensive combination therapies in patients with mild to moderate hypertension. This was a phase II multicenter, randomized, double-blind, parallel-group trial. After a 4-week placebo run-in period, 245 participants were randomized to the third-dose triple combination (ALC group; amlodipine 1.67 mg + losartan potassium 16.67 mg + chlorthalidone 4.17 mg) or third-dose dual combination (AL group; amlodipine 1.67 mg + losartan potassium 16.67 mg, LC group; losartan potassium 16.67 mg + chlorthalidone 4.17 mg, AC group; amlodipine 1.67 mg + chlorthalidone 4.17 mg) therapy groups and followed up for 8 weeks. The mean systolic blood pressure (BP) reduction was -18.3 ± 13.2, -13.0 ± 13.3, -16.3 ± 12.4, and -13.8 ± 13.2 mmHg in the ALC, AL, LC, and AC groups, respectively. The ALC group showed significant systolic BP reduction compared to the AL and AC groups at weeks 4 (P = .010 and P = .018, respectively) and 8 (P = .017 and P = .036, respectively). At week 4, the proportion of systolic BP responders was significantly higher in the ALC group (42.6%) than in the AL (22.0%), LC (23.3%), and AC (27.1%) groups (P = .013, P = .021, and P = .045, respectively). At week 8, the proportion of systolic and diastolic BP responders was significantly higher in the ALC group (59.7%) than in the AL (39.3%) and AC (42.4%) groups (P = .022 and P = .049, respectively) at week 8. Third-standard-dose triple antihypertensive combination therapy demonstrated early effective BP control compared to third-standard-dose dual combination therapies, without increasing adverse drug reactions in patients with mild-to-moderate hypertension.

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