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.
Key words
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Article info
Publication history
Published online: May 06, 2016
Accepted:
April 9,
2016
Identification
Copyright
© 2016 Elsevier Inc. All rights reserved.
