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

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

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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.

Original languageEnglish
Pages (from-to)1412-1421
Number of pages10
JournalClinical Therapeutics
Volume36
Issue number10
DOIs
Publication statusPublished - 2014 Nov 10

Bibliographical note

Funding Information:
This research was financially supported by Boryung Pharmaceutical Co Ltd. The sponsor supported the expenses for medicine, laboratory tests, and the clinical research coordinator. The study was initiated by Boryung Pharmaceutical and was designed, conducted, interpreted, and written by the authors under the supervision of Dr. S.-M. Kang. An external monitoring group was involved in the collection and analysis of data. Drs. J.-C. Youn and S.-M. Kang participated in data analysis and interpretation. Drs. J.-C. Youn, S.-H. Ihm, J.-H Bae, S.-M. Park, D.W. Jeon, B.-C. Jung, T.H. Park, N.H. Lee, J.-M. Song, Y.W. Yoon, E.S. Shin, K.C. Sung, I.H. Jung, W.B. Pyun, S.-J. Joo, W.J. Park, J.H. Shin, and S.-M. Kang participated in study design and acquisition of data. All the authors participated in drafting the article or revising it and approved the final version.

Publisher Copyright:
© 2014 Elsevier HS Journals, Inc. All rights reserved.

All Science Journal Classification (ASJC) codes

  • Pharmacology
  • Pharmacology (medical)

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