Youn, Jong-Chan; Ihm, Sang-Hyun; Bae, Jang-Ho; Park, Seong-Mi; Jeon, Dong Woon; Jung, Byung-Chun; Park, Tae Ho; Lee, Nae Hee; Song, Jong-Min; Yoon, Young Won; Shin, Eun Seok; Sung, Ki Chul; Jung, In Hyun; Pyun, Wook Bum; Joo, Seung-Jae; Park, Woo Jung; Shin, Jin Ho; Kang, Seok-Min
Clinical therapeutics
2014Oct ; 36 ( 10 ) :1412-21.
PMID : 25092393
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Youn, Jong-Chan - Division of Cardiology, Severance Cardiovascular Hospital and Cardiovascular Research Institute, Yonsei University College of Medicine, Seoul, South Korea.
Ihm, Sang-Hyun - Division of Cardiology, Bucheon St. Mary's Hospital, The Catholic University of Korea, Bucheon, South Korea.
Bae, Jang-Ho - Division of Cardiology, Heart Center, Konyang University Hospital, Daejon, South Korea.
Park, Seong-Mi - Division of Cardiology, Anam Hospital, Korea University College of Medicine, Seoul, South Korea.
Jeon, Dong Woon - Division of Cardiology, National Health Insurance Corporation Ilsan Hospital, Goyang, South Korea.
Jung, Byung-Chun - Division of Cardiology, Daegu Fatima Hospital, Daegu, Korea.
Park, Tae Ho - Department of Cardiology, Dong-A University Hospital, Busan, South Korea.
Lee, Nae Hee - Division of Cardiology, Soonchunhyang University Hospital, Bucheon, South Korea.
Song, Jong-Min - Department of Cardiology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea.
Yoon, Young Won - Division of Cardiology, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea.
Shin, Eun Seok - Department of Cardiology, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, South Korea.
Sung, Ki Chul - Division of Cardiology, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, South Korea.
Jung, In Hyun - Department of Internal Medicine, Sejong General Hospital, Bucheon, South Korea.
Pyun, Wook Bum - Division of Cardiology, Ewha Womans University Mokdong Hospital, Seoul, South Korea.
Joo, Seung-Jae - Divison of Cardiology, Jeju National University Hospital, University of Jeju School of Medicine, Jeju, South Korea.
Park, Woo Jung - Division of Cardiology, Hallym University Sacred Heart Hospital, Anyang, South Korea.
Shin, Jin Ho - Division of Cardiology, Hanyang University Hospital, Seoul, South Korea.
Kang, Seok-Min - Division of Cardiology, Severance Cardiovascular Hospital and Cardiovascular Research Institute, Yonsei University College of Medicine, Seoul, South Korea. Electronic address smkang@yuhs.ac.
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. CI - Copyright ??2014 Elsevier HS Journals, Inc. All rights reserved.
keyword
fimasartan; hypertension; placebo; valsartan
MESH
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
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