Efficacy and safety of 30-mg fimasartan for the treatment of patients with mild to moderate hypertension: an 8-week, multicenter, randomized, double-blind, phase III clinical study.

Abstract

PURPOSE:

The standard 60-mg dose of fimasartan, a newly developed selective angiotensin II receptor blocker, is effective and safe for use in patients with mild to moderate hypertension. This study aimed to compare the efficacy and safety of low-dose (30 mg) fimasartan and placebo or valsartan (80 mg) for 8 weeks in patients with mild to moderate hypertension.

METHODS:

In this randomized trial, 293 patients (219 men; mean age, 54.24 [9.77] years) with mild to moderate hypertension were enrolled. After randomization to receive 30-mg fimasartan (n = 115), placebo (n = 117), or 80-mg valsartan (n = 61), the treatment dose was kept constant without dose escalation for 8 weeks. The primary end point was improvement in sitting diastolic blood pressure (SiDBP) from baseline to 8 weeks that was compared between treatments with low-dose fimasartan and placebo. The secondary end point was the overall efficacy and safety of low-dose fimasartan compared with that of placebo or valsartan.

FINDINGS:

At week 8, SiDBP changed by -9.93 (8.86) mm Hg in the fimasartan group and by -2.08 (9.47) mm Hg in the placebo group, which indicated significant antihypertensive efficacy (P < 0.0001). Efficacy was shown at week 4 as measured by SiDBP (-9.96 [7.73] vs -2.27 [7.85] mm Hg; P < 0.0001) or sitting systolic blood pressure (SiSBP) (-16.18 [14.44] vs -1.95 [13.48] mmHg; P < 0.0001) and at week 8 as determined by SiSBP (-15.35 [16.63] vs -2.30 [14.91] mm Hg; P < 0.0001). The fimasartan group exhibited more potent antihypertensive efficacy than the valsartan group both at week 4 (SiDBP, -9.96 [7.73] vs -6.53 [9.58] mm Hg [P = 0.0123]; SiSBP, -16.18 [14.4] vs -7.65 [12.89] mm Hg [P = 0.0002]) and at week 8 (SiDBP, -9.93 [8.86] vs -5.47 [8.96] mm Hg [P = 0.0021]; SiSBP, -15.35 [16.63] vs -7.49 [13.68] mm Hg [P = 0.0021]). Most treatment-emergent adverse events (TEAEs) were mild (89 of 95), and there were no serious TEAEs. The incidence of TEAEs was 19.1% in the fimasartan group, 22.6% in the placebo group, and 13.6% in the valsartan group, with no significant differences.

IMPLICATIONS:

Low-dose fimasartan (30 mg) was well tolerated during the study period with no significant TEAEs. Low-dose fimasartan had an effective blood pressure-lowering effect that was greater than that of 80-mg valsartan in patients with mild to moderate hypertension. ClinicalTrials.gov identifier: NCT01672476.

• Authors: Jong-Chan Youn, Sang-Hyun Ihm, Jang-Ho Bae, Seong-Mi Park, Dong Woon Jeon, Byung-Chun Jung, Tae Ho Park, Nae Hee Lee, Jong-Min Song, Young Won Yoon, Eun Seok Shin, Ki Chul Sung, In Hyun Jung, Wook Bum Pyun, Seung-Jae Joo, Woo Jung Park, Jin Ho Shin, Seok-Min Kang
• Journal: Clinical therapeutics (Clin Ther) Vol. 36 Issue 10 Pg. 1412-21 (Oct 01 2014) ISSN: 1879-114X [Electronic] United States
• PMID: 25092393 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2014 Elsevier HS Journals, Inc. All rights reserved.

Chemical References

• Angiotensin II Type 1 Receptor Blockers
• Antihypertensive Agents
• Biphenyl Compounds
• Pyrimidines
• Tetrazoles
• Valsartan
• fimasartan

Topics

• Adult
• Angiotensin II Type 1 Receptor Blockers (adverse effects, therapeutic use)
• Antihypertensive Agents (adverse effects, therapeutic use)
• Biphenyl Compounds (adverse effects, therapeutic use)
• Blood Pressure (drug effects)
• Double-Blind Method
• Female
• Humans
• Hypertension (drug therapy, physiopathology)
• Male
• Middle Aged
• Pyrimidines (adverse effects, therapeutic use)
• Tetrazoles (adverse effects, therapeutic use)
• Treatment Outcome
• Valsartan (adverse effects, therapeutic use)