Blood pressure-lowering treatment with candesartan in patients with acute hemorrhagic stroke.

BACKGROUND AND PURPOSE: Early and intensive blood pressure-lowering treatment seems to be beneficial in patients with acute hemorrhagic stroke and high blood pressure. We wanted to see if similar benefits can be shown from a later and more gradual blood pressure lowering, using data from the Scandinavian Candesartan Acute Stroke Trial (SCAST).

METHODS: SCAST was a randomized- and placebo-controlled, double-masked trial of candesartan given for 7 days, in 2029 patients with acute stroke and systolic blood pressure ≥140 mm Hg. We assessed the effects of candesartan in the 274 patients with hemorrhagic stroke, using the trial's 2 coprimary effect variables: the composite vascular end point of vascular death, stroke or myocardial infarction, and functional outcome at 6 months, according to the modified Rankin Scale. We used Cox proportional hazards models and ordinal regression for analysis and adjusted for key, predefined prognostic variables.

RESULTS: There was no association between treatment with candesartan and risk of vascular events (17 of 144 [11.8%] versus 13 of 130 [10.0%]; hazard ratio, 1.36; 95% confidence interval, 0.65-2.83; P=0.41). For functional outcome we found evidence of a negative effect of candesartan (common odds ratio, 1.61; 95% confidence interval, 1.03-2.50; P=0.036).

CONCLUSIONS: There was no evidence that blood pressure-lowering treatment with candesartan is beneficial during the first week of hemorrhagic stroke. Instead, there were signs that such treatment may be harmful, but this needs to be verified in larger studies.

CLINICAL TRIAL REGISTRATION URL: https://www.clinicaltrials.gov. Unique identifier: NCT00120003.