Korean J Intern Med. 2017;32(6):1025-1036.

24-Hour blood pressure response to lower dose (30 mg) fimasartan in Korean patients with mild to moderate essential hypertension.

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제1저자 이해영 · 교신저자 오병희

PMID 29032666 PMC5668394 DOI 10.3904/kjim.2016.094 IF 2.2 순환기내과

소속 (6)

Department of Internal Medicine, Seoul National University Hospital, Seoul, Korea.
Department of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, Korea.
Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
Department of Internal Medicine, Kyungpook National University Hospital, Daegu, Korea.
Department of Internal Medicine, The Heart Center of Chonnam National University Hospital, Gwangju, Korea.
Department of Internal Medicine, Inje University Busan Paik Hospital, Busan, Korea.

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 ≥ 135/85 mmHg, 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 ± 11.9 mmHg (p < 0.0001) in the fimasartan group and -5.5 ± 11.6 mmHg (p = 0.0307) in the valsartan group. The difference between two groups was 4.3 ± 2.9 mmHg 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

Angiotensin II type 1 receptor blockersBlood pressure monitoring, ambulatoryHypertension

Figures

**Figure 1.** Study design. ABPM, ambulatory blood pressure monitor. ^a Previous anti-hypertensive medication users only.

**Figure 2.** Patients recruitment and flow.

**Figure 3.** 24-Hour systolic blood pressure (SBP) profiles and change from the baseline at week 8. 24-Hour SBP profiles of (A) fimasartan 30 mg and (B) valsartan 30 mg by time after dosing. (C) Change from the baseline at week 8 in 24-hour SBP. Data were analyzed on full analysis set. CI, confidence C interval.

**Figure 4.** The changes of the mean (A) 24-hour, (B) the daytime, and (C) the nighttime blood pressures (BPs) from the baseline at week 8. SBP, systolic blood pressure; DBP, diastolic blood pressure.

그림 출처: PubMed Central 공개 논문 (PMC5668394)

Conflict of interest statement

This study was sponsored by Boryung pharmaceutical, Seoul, Korea. The sponsor supported the supply of the investigational products, laboratory test, and clinical research coordinator expenses.

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