Hong, Soon Jun; Jeong, Han Saem; Cho, Jin-Man; Chang, Kiyuk; Pyun, Wook Bum; Ahn, Youngkeun; Hyon, Min Su; Kang, Woong Chol; Lee, Jae-Hwan; Kim, Hyo-Soo
Clinical therapeutics
2019Jan ; 124 ( 2 ) :.
PMID : 30665829
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Hong, Soon Jun - Department of Cardiology, Cardiovascular Center, Korea University Anam Hospital, Seoul, Republic of Korea.
Jeong, Han Saem - Department of Cardiology, Cardiovascular Center, Korea University Anam Hospital, Seoul, Republic of Korea.
Cho, Jin-Man - Division of Cardiology, Kyung Hee University Hospital at Gangdong, Seoul, Republic of Korea.
Chang, Kiyuk - Cardiology Division, Department of Internal Medicine, Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul, Republic of Korea.
Pyun, Wook Bum - Department of Cardiology, Ewha Womans University Mokdong Hospital, Seoul, Republic of Korea.
Ahn, Youngkeun - Department of Cardiology, Soon Chun Hyang University Hospital Seoul, Seoul, Republic of Korea.
Hyon, Min Su - Department of Cardiology, Chonnam National University Hospital, Gwangju, Republic of Korea.
Kang, Woong Chol - Department of Cardiology, Gachon University Gil Medical Center, Incheon, Republic of Korea.
Lee, Jae-Hwan - Department of Cardiology, Chungnam National University Hospital, Daejeon, Republic of Korea.
Kim, Hyo-Soo - Division of Cardiology, Department of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea. Electronic address: usahyosoo@gmail.com.
ABSTRACT
PURPOSE: Fixed-dose combination therapy with telmisartan, amlodipine, and rosuvastatin is needed in patients with hypertension and dyslipidemia for better adherence and cost-effectiveness than free-equivalent combination therapies. This study aimed to compare the efficacy and safety of combination therapy with telmisartan, amlodipine, and rosuvastatin versus telmisartan plus amlodipine or telmisartan plus rosuvastatin in patients with hypertension and dyslipidemia.
METHODS: The Jeil Telmisartan, Amlodipine, and Rosuvastatin Randomized Clinical Trial (J-TAROS-RCT) was an 8-week, multicenter, randomized, double-blind, parallel, Phase III clinical trial conducted at 9 hospitals in Korea. After a run-in period of >4 weeks, patients who fulfilled the criteria of the National Cholesterol Education Program Adult Treatment Panel III guidelines were eligible for randomization to receive 1 of 3 treatments for 8 weeks: (1) telmisartan/amlodipine 80 mg/10?mg plus rosuvastatin 20?mg, (2) telmisartan/amlodipine 80 mg/10?mg, or (3) telmisartan 80?mg plus rosuvastatin 20?mg. The primary end point was efficacy evaluation of combination therapy with telmisartan/amlodipine/rosuvastatin by comparing the change in mean sitting systolic blood pressure (msSBP) and mean percentage change in LDL-C from baseline after 8 weeks of treatment. Adverse events (AEs), clinical laboratory data, and vital signs were assessed in all patients. FINDINGS: Among 148 patients, the changes in msSBP from baseline after 8 weeks of treatment were a mean (SD) of?-24.41 (2.38) versus?-9.31 (2.36) mm Hg in the telmisartan/amlodipine/rosuvastatin and telmisartan/rosuvastatin groups, respectively. Significantly more participants achieved the target BP at week 8 in the telmisartan/amlodipine/rosuvastatin group (41 patients [87.2%]) than in the telmisartan/rosuvastatin group (24 [50.0%], P?
keyword
amlodipine; hypercholesterolemia; rosuvastatin; singe-pill combination; telmisartan
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