Fimasartan-Based Blood Pressure Control after Acute Cerebral Ischemia: The Fimasartan-Based Blood Pressure Control
Keun Sik Hong1, Sun Uck Kwon2, Jong Ho Park3
1Department of Neurology, Ilsan Paik Hospital, Inje University, Goyang, Korea. nrhks455@gmail.com.
Insights
Fimasartan-based therapy effectively controlled high blood pressure (BP) in two-thirds of recent cerebral ischemia patients within 24 weeks. This antihypertensive approach demonstrated good tolerability in the study population.
Area of Science:
- Cardiology
- Neurology
- Pharmacology
Background:
- Blood pressure (BP) control is crucial, especially post-stroke, but control rates are understudied.
- This study focuses on BP control in patients with recent cerebral ischemia.
Purpose of the Study:
- To evaluate the BP control rate using fimasartan-based antihypertensive therapy.
- To assess the efficacy and tolerability of fimasartan in managing hypertension in patients with recent cerebral ischemia.
Main Methods:
- A multicenter, prospective, single-arm trial involving 27 South Korean centers.
- Inclusion criteria: recent cerebral ischemia (within 90 days) and high BP (SBP >140 mm Hg or DBP >90 mm Hg).
- Primary endpoint: Target BP goal achievement rate (<140/90 mm Hg) at 24 weeks.
Main Results:
- The target BP goal achievement rate at 24 weeks was 67.3%.
- Mean BP decreased significantly from baseline (162.3/92.2 mm Hg) to 132.8/78.5 mm Hg at 24 weeks.
- The treatment-emergent adverse event rate was low at 5.4%.
Conclusions:
- Fimasartan-based therapy effectively achieved target BP in approximately two-thirds of patients with recent cerebral ischemia.
- The antihypertensive regimen was generally well-tolerated, indicating its potential utility in this patient group.
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.
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