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Efficacy and safety of combination therapy with telmisartan, rosuvastatin, and ezetimibe in patients with dyslipidemia and hypertension: A randomized, double-blind, multicenter, therapeutic confirmatory, phase III clinical trial.

Division of Cardiology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea. Department of Cardiology, Gil Hospital, Gachon University, Incheon, South Korea. Division of Cardiology, Department of Internal Medicine, Bucheon St. Mary's Hospital, The Catholic University of Korea, Seoul, South Korea. Department of Cardiology, Kyung Hee University Hospital at Gangdong, Seoul, South Korea. Department of Internal Medicine, Kyung Hee University College of Medicine, Kyung Hee University Medical Center, Seoul, South Korea. Division of Interventional Cardiology, Cardiovascular Center, Korea University Guro Hospital, Seoul, South Korea. Division of Cardiology, Department of Internal Medicine, Korea University Anam Hospital, Seoul, South Korea. Division of Cardiology, Department of Internal Medicine, Pusan National University School of Medicine, Busan, South Korea. Division of Cardiology, Department of Internal Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea. Division of Cardiology, Department of Internal Medicine, Boramae Medical Center, Seoul National University College of Medicine, Seoul, South Korea. Division of Cardiology, Department of Medicine, Inje University Ilsan Paik Hospital, Goyang, South Korea. Division of Cardiology, Department of Internal Medicine, Wonju Severance Christian Hospital, Yonsei University Wonju College of Medicine, Wonju, South Korea. Department of Cardiology in Internal Medicine, Chungnam National University Hospital, School of Medicine, Chungnam National University, Daejeon, South Korea. Division of Cardiology, Department of Internal Medicine, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, South Korea. Division of Cardiology, Chonnam National University Medical School, Chonnam National University Hopital, Gwangju, South Korea. Division of Cardiology, Department of Internal Medicine, Kosin University Gospel Hospital, Busan, South Korea. Division of Cardiology, Department of Internal Medicine, Hanyang University Seoul Hospital, Hanyang University College of Medicine, Seoul, South Korea.

Journal of clinical hypertension (Greenwich, Conn.). 2024;(3):262-273
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Abstract

This study aimed to compare and evaluate the efficacy of the blood pressure (BP) control and cholesterol-lowering effects and safety of combination therapy with telmisartan, rosuvastatin, and ezetimibe versus rosuvastatin and ezetimibe double therapy or telmisartan single therapy in dyslipidemia patients with hypertension. After a wash-out/therapeutic lifestyle change period of ≥4 weeks, a total of 100 eligible patients were randomized and received one of three treatments for 8 weeks: (1) telmisartan 80 mg/rosuvastatin 20 mg/ezetimibe 10 mg (TRE), (2) rosuvastatin 20 mg/ezetimibe 10 mg (RE), or (3) telmisartan 80 mg (T). The primary endpoint was the efficacy evaluation of TRE by comparing changes in mean sitting systolic blood pressure (msSBP) and mean percentage change in low-density lipoprotein-C (LDL-C) from baseline after 8 weeks of treatment. The least square (LS) mean (SE) changes in msSBP at 8 weeks compared with baseline were -23.02 (3.04) versus -7.18 (3.09) mmHg in the TRE and RE groups, respectively (p < .0001), and -25.80 (2.74) versus -14.92 (2.65) mmHg in the TRE and T groups, respectively (p = .0005). The percentage changes in the mean (SD) LDL-C at 8 weeks compared with baseline were -54.97% (3.49%) versus -0.17% (3.23%) in the TRE and T groups, respectively (p < .0001). No serious adverse events occurred, and no statistically significant differences in the incidence of overall AEs and adverse drug reactions occurred among the three groups. TRE therapy significantly decreased msSBP and LDL-C compared to RE or T therapy with comparable safety and tolerability profiles.

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