title: 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: OBJECTIVE
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.affiliation: Division of Cardiology, Severance Cardiovascular Hospital and Cardiovascular Research Institute, Yonsei University College of Medicine, Seoul, South Korea.
authors.forename: Jong-Chan
authors.initials: JC
authors.lastname: Youn
authors.affiliation: Division of Cardiology, Bucheon St. Mary's Hospital, The Catholic University of Korea, Bucheon, South Korea.
authors.forename: Sang-Hyun
authors.initials: SH
authors.lastname: Ihm
authors.affiliation: Division of Cardiology, Heart Center, Konyang University Hospital, Daejon, South Korea.
authors.forename: Jang-Ho
authors.initials: JH
authors.lastname: Bae
authors.affiliation: Division of Cardiology, Anam Hospital, Korea University College of Medicine, Seoul, South Korea.
authors.forename: Seong-Mi
authors.initials: SM
authors.lastname: Park
authors.affiliation: Division of Cardiology, National Health Insurance Corporation Ilsan Hospital, Goyang, South Korea.
authors.forename: Dong Woon
authors.initials: DW
authors.lastname: Jeon
authors.affiliation: Division of Cardiology, Daegu Fatima Hospital, Daegu, Korea.
authors.forename: Byung-Chun
authors.initials: BC
authors.lastname: Jung
authors.affiliation: Department of Cardiology, Dong-A University Hospital, Busan, South Korea.
authors.forename: Tae Ho
authors.initials: TH
authors.lastname: Park
authors.affiliation: Division of Cardiology, Soonchunhyang University Hospital, Bucheon, South Korea.
authors.forename: Nae Hee
authors.initials: NH
authors.lastname: Lee
authors.affiliation: Department of Cardiology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea.
authors.forename: Jong-Min
authors.initials: JM
authors.lastname: Song
authors.affiliation: Division of Cardiology, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea.
authors.forename: Young Won
authors.initials: YW
authors.lastname: Yoon
authors.affiliation: Department of Cardiology, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, South Korea.
authors.forename: Eun Seok
authors.initials: ES
authors.lastname: Shin
authors.affiliation: Division of Cardiology, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, South Korea.
authors.forename: Ki Chul
authors.initials: KC
authors.lastname: Sung
authors.affiliation: Department of Internal Medicine, Sejong General Hospital, Bucheon, South Korea.
authors.forename: In Hyun
authors.initials: IH
authors.lastname: Jung
authors.affiliation: Division of Cardiology, Ewha Womans University Mokdong Hospital, Seoul, South Korea.
authors.forename: Wook Bum
authors.initials: WB
authors.lastname: Pyun
authors.affiliation: Divison of Cardiology, Jeju National University Hospital, University of Jeju School of Medicine, Jeju, South Korea.
authors.forename: Seung-Jae
authors.initials: SJ
authors.lastname: Joo
authors.affiliation: Division of Cardiology, Hallym University Sacred Heart Hospital, Anyang, South Korea.
authors.forename: Woo Jung
authors.initials: WJ
authors.lastname: Park
authors.affiliation: Division of Cardiology, Hanyang University Hospital, Seoul, South Korea.
authors.forename: Jin Ho
authors.initials: JH
authors.lastname: Shin
authors.affiliation: Division of Cardiology, Severance Cardiovascular Hospital and Cardiovascular Research Institute, Yonsei University College of Medicine, Seoul, South Korea. Electronic address: smkang@yuhs.ac.
authors.forename: Seok-Min
authors.initials: SM
authors.lastname: Kang
mesh_terms: D000328:Adult; D047228:Angiotensin II Type 1 Receptor Blockers / Q000009:adverse effects / Q000627:therapeutic use*; D000959:Antihypertensive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001713:Biphenyl Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D001794:Blood Pressure / Q000187:drug effects; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006973:Hypertension / Q000188:drug therapy* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D011743:Pyrimidines / Q000009:adverse effects / Q000627:therapeutic use*; D013777:Tetrazoles / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D000068756:Valsartan / Q000009:adverse effects / Q000627:therapeutic use
chemical_list: D047228:Angiotensin II Type 1 Receptor Blockers; D000959:Antihypertensive Agents; D001713:Biphenyl Compounds; D011743:Pyrimidines; D013777:Tetrazoles; D000068756:Valsartan; C558933:fimasartan
keywords: fimasartan; hypertension; placebo; valsartan