Kim, Tae-Seok; Rha, Seung-Woon; Kim, Seok-Yeon; Park, Dae-Gyun; Sung, Ki-Chul; Yoon, Myung-Ho; Kim, Kye-Hoon; Lee, Han-Cheol; Kim, Woo-Sik; Kim, Yong-Jin; Ahn, Jeong-Cheon; Rhee, Moo-Yong; Cha, Dong-Hun; Yoo, Byung-Su; Park, Sang-Ho; Yoo, Ki-Dong; Jeon, Dong-Woon; Yoon, Young-Won; Cho, Sang-Kyoon; Oh, Yong-Seog
Clinical therapeutics
2019Mar ; 9 ( 3 ) :.
PMID : 30904178
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Kim, Tae-Seok -
Rha, Seung-Woon -
Kim, Seok-Yeon -
Park, Dae-Gyun -
Sung, Ki-Chul -
Yoon, Myung-Ho -
Kim, Kye-Hoon -
Lee, Han-Cheol -
Kim, Woo-Sik -
Kim, Yong-Jin -
Ahn, Jeong-Cheon -
Rhee, Moo-Yong -
Cha, Dong-Hun -
Yoo, Byung-Su -
Park, Sang-Ho -
Yoo, Ki-Dong -
Jeon, Dong-Woon -
Yoon, Young-Won -
Cho, Sang-Kyoon -
Oh, Yong-Seog -
ABSTRACT
PURPOSE: Dyslipidemia and hypertension increase the risk for cardiovascular disease. Combination therapy improves patient compliance. This study was conducted to compare the efficacy and tolerability of the combination therapies telmisartan/amlodipine?+ rosuvastatin, telmisartan/amlodipine, and telmisartan + rosuvastatin in patients with hypercholesterolemia and hypertension.
METHODS: In this Phase III, multicenter, 8-week randomized, double-blind study, participants with hypertension and dyslipidemia (defined as a sitting systolic blood pressure [sitSBP] of ??40?mm Hg, a low-density lipoprotein-cholesterol [LDL-C] level of ??50?mg/dL, and a triglyceride level of ??00?mg/dL) were screened. After a 4-week washout/run-in period involving therapeutic lifestyle changes and telmisartan 80?mg once a day, eligible patients had a sitSBP of ??40?mm Hg and met the LDL-C level criteria according to the National Cholesterol Education Program Adult Treatment Panel III cardiovascular disease risk category. Patients were randomly assigned to 1 of 3 groups: (1) telmisartan/amlodipine 80/10?mg?+?rosuvastatin 20?mg (TAR group); (2) telmisartan/amlodipine 80/10?mg?(TA group); or (3) telmisartan 80?mg?+?rosuvastatin 20?mg?(TR group). The primary efficacy end points were the percentage changes from baseline in LDL-C in the TAR and TA groups and the mean changes in sitSBP in the TAR and TR groups at week 8 compared to baseline. Continuous variables were compared using the unpaired t test or the Wilcoxon rank sum model, and categorical variables were compared using the ?(2) or Fisher exact test. Tolerability was assessed based on adverse events found on physical examination including vital sign measurements, laboratory evaluations, and 12-lead ECG. FINDINGS: A total of 134 patients were enrolled. The least squares mean percentage changes in LDL-C at 8 weeks after administration of the drug compared to baseline were?-51.9% (3.0%) in the TAR group and?-3.2% (2.9%) in the TA group (P?
keyword
amlodipine; dyslipidemia; hypertension; rosuvastatin; telmisartan; triple combination
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