A Randomized, Double-blind, Candesartan-controlled, Parallel Group Comparison Clinical Trial to Evaluate the Antihypertensive Efficacy and Safety of Fimasartan in Patients with Mild to Moderate Essential Hypertension

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• 作者：Jang Hoon Lee ; MD¹ ; Dong Heon Yang ; MD¹ ; Jin Yong Hwang ; MD² ; Seung Ho Hur ; MD³ ; Tae Joon Cha ; MD⁴ ; Ki-Sik Kim ; MD⁵ ; Moo Hyun Kim ; MD⁶ ; Kook Jin Chun ; MD⁷ ; Gwang Soo Cha ; MD⁸ ; Geu Ru Hong ; MD⁹ ; Sang Gon Lee ; MD¹⁰ ; Dong Soo Kim ; MD¹¹ ; Doo Il Kim ; MD¹² ; Shung Chull Chae ; MD¹ ; ^{scchae@knu.ac.kr" class="auth_mail" title="E-mail the corresponding author}
• 关键词：angiotensin receptor blocker ; candesartan ; fimasartan ; hypertension
• 刊名：Clinical Therapeutics
• 出版年：2016
• 出版时间：June 2016
• 年：2016
• 卷：38
• 期：6
• 页码：1485-1497
• 全文大小：389 K

文摘

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.