Fimasartan-Based Blood Pressure Control after Acute Cerebral Ischemia: The Fimasartan-Based Blood Pressure Control after Acute Cerebral Ischemia Study
10.3988/jcn.2021.17.3.344
- Author:
Keun-Sik HONG
1
;
Sun Uck KWON
;
Jong-Ho PARK
;
Jae-Kwan CHA
;
Jin-Man JUNG
;
Yong-Jae KIM
;
Kyung Bok LEE
;
Sung Il SOHN
;
Yong-Seok LEE
;
Joung-Ho RHA
;
Jee-Hyun KWON
;
Sang Won HAN
;
Bum Joon KIM
;
Jaseong KOO
;
Jay Chol CHOI
;
Sang Min SUNG
;
Soo Joo LEE
;
Man-Seok PARK
;
Seong Hwan AHN
;
Oh Young BANG
;
Yang-Ha HWANG
;
Hyo Suk NAM
;
Jong-Moo PARK
;
Hee-Joon BAE
;
Eung Gyu KIM
;
Kyung-Yul LEE
;
Mi Sun OH
Author Information
1. Department of Neurology, Ilsan Paik Hospital, Inje University, Goyang, Korea
- Publication Type:ORIGINAL ARTICLE
- From:Journal of Clinical Neurology
2021;17(3):344-353
- CountryRepublic of Korea
- Language:English
-
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.
