J Clin Neurol.  2021 Jul;17(3):344-353. 10.3988/jcn.2021.17.3.344.

Fimasartan-Based Blood Pressure Control after Acute Cerebral Ischemia: The Fimasartan-Based Blood Pressure Control after Acute Cerebral Ischemia Study

Affiliations
  • 1Department of Neurology, Ilsan Paik Hospital, Inje University, Goyang, Korea
  • 2Department of Neurology, Asan Medical Center, University of Ulsan, Seoul, Korea
  • 3Department of Neurology, Myongji Hospital, Hanyang University College of Medicine, Goyang, Korea
  • 4Department of Neurology, Dong-A University Hospital, Busan, Korea
  • 5Department of Neurology, Korea University Ansan Hospital, Ansan, Korea
  • 6Department of Neurology, Eunpyeong St. Mary’s Hospital, The Catholic University of Korea, Seoul, Korea
  • 7Department of Neurology, Soonchunhyang University Hospital, Seoul, Korea
  • 8Department of Neurology, Keimyung University Dongsan Hospital, Daegu, Korea
  • 9Department of Neurology, Seoul Metropolitan Government-Seoul National University Boramae Medical Center, Seoul, Korea
  • 10Department of Neurology, Inha University Hospital, Incheon, Korea
  • 11Department of Neurology, Ulsan University College of Medicine, Ulsan, Korea
  • 12Department of Neurology, Sanggye Paik Hospital, Inje University College of Medicine, Seoul, Korea
  • 13Department of Neurology, Seoul St. Mary’s Hospital, The Catholic University of Korea, Seoul, Korea
  • 14Department of Neurology, Jeju National University Hospital, Jeju National University School of Medicine, Jeju, Korea
  • 15Department of Neurology, Pusan National University Hospital, Busan, Korea
  • 16Department of Neurology, Daejeon Eulji University Hospital, Eulji University, Daejeon, Korea
  • 17Department of Neurology, Chonnam National University Medical School & Hospital, Gwangju, Korea
  • 18Department of Neurology, Chosun University School of Medicine, Gwangju, Korea
  • 19Department of Neurology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea
  • 20Department of Neurology, Kyungpook National University Hospital, School of Medicine, Kyungpook National University, Daegu, Korea
  • 21Department of Neurology, Yonsei University College of Medicine, Seoul, Korea
  • 22Department of Neurology, Uijeongbu Eulji Medical Center, Eulji University School of Medicine, Uijeongbu, Korea
  • 23Department of Neurology, Cerebrovascular Center, Seoul National University Bundang Hospital, Seongnam, Korea
  • 24Department of Neurology, Inje University Busan Paik Hospital, Busan, Korea
  • 25Department of Neurology, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea
  • 26Department of Neurology, Hallym University Sacred Heart Hospital, Anyang, Korea

Abstract

Background and Purpose
Blood pressure (BP) control is strongly recommended, but BP control rate has not been well studied in patients with stroke. We evaluated the BP control rate with fimasartan-based antihypertensive therapy initiated in patients with recent cerebral ischemia.
Methods
This multicenter, prospective, single-arm trial involved 27 centers in South Korea. Key inclusion criteria were recent cerebral ischemia within 90 days and high BP [systolic blood pressure (SBP) >140 mm Hg or diastolic blood pressure (DBP) >90 mm Hg]. BP lowering was initiated with fimasartan. BP management during the follow-up was at the discretion of the responsible investigators. The primary endpoint was the target BP goal achievement rate (<140/90 mm Hg) at 24 weeks. Key secondary endpoints included achieved BP and BP changes at each visit, and clinical events (ClinicalTrials.gov Identifier: NCT03231293).
Results
Of 1,035 patients enrolled, 1,026 were included in the safety analysis, and 951 in the efficacy analysis. Their mean age was 64.1 years, 33% were female, the median time interval from onset to enrollment was 10 days, and the baseline SBP and DBP were 162.3±16.0 and 92.2±12.4 mm Hg (mean±SD). During the study period, 55.5% of patients were maintained on fimasartan monotherapy, and 44.5% received antihypertensive therapies other than fimasartan monotherapy at at least one visit. The target BP goal achievement rate at 24-week was 67.3% (48.6% at 4-week and 61.4% at 12-week). The mean BP was 139.0/81.8±18.3/11.7, 133.8/79.2±16.4/11.0, and 132.8/78.5±15.6/10.9 mm Hg at 4-, 12-, and 24-week. The treatment-emergent adverse event rate was 5.4%, including one serious adverse event.
Conclusions
Fimasartan-based BP lowering achieved the target BP in two-thirds of patients at 24 weeks, and was generally well tolerated.

Keyword

blood pressure; prevention and control; stroke; fimasartan
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