Lee, Jang Hoon; Yang, Dong Heon; Hwang, Jin Yong; Hur, Seung Ho; Cha, Tae Joon; Kim, Ki-Sik; Kim, Moo Hyun; Chun, Kook Jin; Cha, Gwang Soo; Hong, Geu Ru; Lee, Sang Gon; Kim, Dong Soo; Kim, Doo Il; Chae, Shung Chull
Clinical therapeutics
2016May ; 11 ( 9 ) :.
PMID : 27161546
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Lee, Jang Hoon - Kyungpook National University School of Medicine, Daegu, Republic of Korea.
Yang, Dong Heon - Kyungpook National University School of Medicine, Daegu, Republic of Korea.
Hwang, Jin Yong - Gyeongsang National University School of Medicine, Jinju, Republic of Korea.
Hur, Seung Ho - Keimyung University Dongsan Medical Center, Daegu, Republic of Korea.
Cha, Tae Joon - Kosin University Gospel Hospital, Busan, Republic of Korea.
Kim, Ki-Sik - Daegu Catholic University Hospital, Daegu, Republic of Korea.
Kim, Moo Hyun - Donga University Hospital, Busan, Republic of Korea.
Chun, Kook Jin - Pusan National University Yangsan Hospital, Yangsan, Republic of Korea.
Cha, Gwang Soo - Pusan University Hospital, Busan, Republic of Korea.
Hong, Geu Ru - Yeungnam University Medical Center, Daegu, Republic of Korea.
Lee, Sang Gon - Ulsan University Hospital, Ulsan, Republic of Korea.
Kim, Dong Soo - Inje University Pusan Paik Hospital, Busan, Republic of Korea.
Kim, Doo Il - Inje University Haeundae Baik Hospital, Busan, Republic of Korea.
Chae, Shung Chull - Kyungpook National University School of Medicine, Daegu, Republic of Korea. Electronic address scchae@knu.ac.kr.
ABSTRACT
PURPOSE: A new antihypertensive drug that selectively blocks angiotensin II receptor type 1, fimasartan, has a potent and rapidly acting antihypertensive effect. We investigated the antihypertensive effects of fimasartan 60 and 120 mg and its safety in comparison to 8 mg of candesartan.
METHODS: This clinical trial is a multicenter, randomized, double-blind, active comparator, and parallel group study. Three hundred sixty-two individuals were screened, and 290 patients aged 19 to 75 years with mild to moderate hypertension (diastolic blood pressure [DBP], 90-110 mm Hg) were randomly assigned to 60 to 120 mg/d of fimasartan or 8 mg/d of candesartan after a 2-week placebo run-in period. Treatments were administered for 12 weeks without dosage adjustment. The primary end point was the differences in DBP changes at week 12. FINDINGS: After 12 weeks of treatment, DBP and systolic blood pressure (SBP) decreased significantly in all 3 groups. The decrease in DBP at week 12 was larger but not statistically significant in the fimasartan 60 mg compared with the candesartan 8 mg group with a mean (SD) difference of 1.72 (8.32) mm Hg (95% CI, -0.71 to 4.15 mm Hg; P = 0.17). The lower margin of the CI (-0.71 mm Hg) exceeded the noninferiority margin (-3.5 mm Hg). The DBP-lowering effect of fimasartan 120 mg was also nonsignificantly larger than candesartan 8 mg (difference, 1.58 [8.27] mm Hg; P = 0.20). The decrease in SBP was also nonsignificantly larger in the fimasartan 60 mg group compared with the candesartan 8 mg group (difference, 3.50 [12.63] mm Hg; P = .06). The SBP-lowering effect of fimasartan 120 mg was statistically larger than candesartan 8 mg (difference, 4.98 [13.99] mm Hg; P = .02). Response rate (DBP <90 mm Hg or DBP lowering >10 mm Hg at week 12) was also nonsignificantly greater in both fimasartan groups (Fimasartan 60 mg, 81%; fimasartan 120 mg, 72%; candesartan 8 mg, 71%). The safety profile of the fimasartan 60 mg and 120 mg was similar to candesartan 8 mg, with a slightly higher, but statistically not significant, incidence of hepatic enzyme elevation in fimasartan 120 mg. IMPLICATIONS: The antihypertensive effect of fimasartan, a newly available angiotensin II receptor type 1 blocker, is comparable, although not superior, to candesartan with a good safety profile. ClinicalTrials.gov identifier: NCT01135212. CI - Copyright ??2016 Elsevier HS Journals, Inc. All rights reserved.
keyword
angiotensin receptor blocker; candesartan; fimasartan; hypertension
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