Rick Frieden, MD
Does candesartan improve clinical or functional outcomes in patients with acute stroke and elevated blood pressure (BP)?
Randomized placebo-controlled trial (Scandinavian Candesartan Acute Stroke Trial [SCAST]). ClinicalTrials.gov NCT00120003, Current Controlled Trials ISRCTN13643354, EudraCT 2004-002187-22.
Blinded (patients, clinicians, outcome assessors, and event adjudicators).*
146 centers in 9 North European countries.
2029 patients ≥ 18 years of age (mean age 71 y, 58% men, 85% ischemic stroke, mean BP 171/90 mm Hg) who had a clinical diagnosis of stroke (ischemic or hemorrhagic), symptom onset ≤ 30 hours before presentation, and systolic BP > 140 mm Hg. Exclusion criteria included life expectancy ≤ 12 months, Scandinavian Stroke Scale consciousness score ≤ 2, premorbid modified Rankin Scale (mRS) score ≥ 4, current use of or indication for an angiotensin-receptor blocker, and indication for antihypertensive treatment during acute stroke.
Candesartan, 4 mg on day 1, 8 mg on day 2, and 16 mg on days 3 to 7 (n = 1017); or placebo (n = 1012).
Primary outcomes were functional status (mRS score) and a composite vascular endpoint (nonfatal myocardial infarction [MI] or stroke, or vascular death). 2500 patients were needed to detect a 6% absolute risk reduction in death or major disability from 60% at 6 months (80% power, α = 0.05) and account for loss to follow-up and use of 2 coprimary endpoints.
Mean BP was lower with candesartan than placebo at 7 days (147/82 vs 152/84 mm Hg, P < 0.001) but not at 6 months (143/81 mm Hg in both groups). At 6 months, groups did not differ for the composite vascular endpoint or functional status (Table).
Candesartan did not improve clinical or functional outcomes in patients with acute stroke and elevated blood pressure.
Candesartan vs placebo in patients with acute stroke and elevated blood pressure†
†mRS = modified Rankin Scale; other abbreviations defined in Glossary. RRI and CI calculated from data in article.
‡Adjusted for age, cause of stroke (ischemic vs other), systolic blood pressure, and baseline Scandinavian Stroke Scale score.
§Nonfatal myocardial infarction (0.8% vs 0.6%), nonfatal stroke (4.8% vs 4.4%), vascular death (6.2% vs 5.9%).
Frieden R. Candesartan did not improve clinical or functional outcomes in patients with acute stroke and elevated BP. Ann Intern Med. ;154:JC6–5. doi: 10.7326/0003-4819-154-12-201106210-02005
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Published: Ann Intern Med. 2011;154(12):JC6-5.
Cardiology, Coronary Risk Factors, Hypertension, Nephrology, Neurology.
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