The Korean journal of internal medicine

The Korean Association of Internal Medicine (대한내과학회)
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24-Hour blood pressure response to lower dose (30 mg) fimasartan in Korean patients with mild to moderate essential hypertension

  • Lee, Hae-Young (Department of Internal Medicine, Seoul National University Hospital) ;
  • Kim, Cheol-Ho (Seoul National University Bundang Hospital) ;
  • Song, Jae-Kwan (Asan Medical Center, University of Ulsan College of Medicine) ;
  • Chae, Shung Chull (Kyungpook National University Hospital) ;
  • Jeong, Myung Ho (The Heart Center of Chonnam National University Hospital) ;
  • Kim, Dong-Soo (Inje University Busan Paik Hospital) ;
  • Oh, Byung-Hee (Department of Internal Medicine, Seoul National University Hospital)
  • Received : 2016.03.20
  • Accepted : 2016.08.23
  • Published : 2017.11.01
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Abstract

Background/Aims: Fimasartan is an angiotensin type 1 receptor blocker (ARB) which has comparable efficacy and tolerability with other ARBs. The aim of this study was to evaluate 24-hour blood pressure (BP) lowering efficacy and the tolerability of the low dose fimasartan compared with valsartan in patients with mild to moderate hypertension. Methods: This study was a phase II, prospective, multicenter, randomized, double-blind, parallel-grouped trial. A total of 75 hypertensive patients, whose mean ambulatory BP monitoring values were ${\geq}135/85mmHg$, were randomized to either fimasartan 30 mg or valsartan 80 mg daily. The primary efficacy endpoint was the change in the mean 24-hour systolic BP (SBP) values from the baseline and at the week 8. Secondary endpoints included the change in the mean 24-hour diastolic BP values, the daytime and the nighttime mean BP values at week 8, the trough-to-peak (T/P) ratio and the smoothness index. Results: At week 8, the mean 24-hour SBP values significantly decreased in both groups; $-10.5{\pm}11.9mmHg$ (p < 0.0001) in the fimasartan group and $-5.5{\pm}11.6mmHg$ (p = 0.0307) in the valsartan group. The difference between two groups was $4.3{\pm}2.9mmHg$ but there was no statistical significance (p = 0.1392). The global T/P ratio in the fimasartan 30 mg groups were 0.48 and 0.40 in the valsartan 80 mg group, respectively (p = 0.3411). The most frequent adverse events (AEs) were acute pharyngitis and there were no cases of severe AEs. Conclusions: In mild-to-moderate hypertensive patients, low dose (30 mg) fimasartan showed comparable 24-hour BP lowering efficacy compared with valsartan (80 mg). There was no difference in tolerability between two groups.

Keywords

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