Clinical Question: Does candesartan reduce the rate of stroke mortality and other complications in patients with acutely elevated blood pressure?
Setting: Inpatient (any location)
Study Design: Randomized controlled trial (double-blinded)
Synopsis: Although the use of thrombolytics is controversial in the management of acute ischemic stroke, many other effective interventions can reduce adverse outcomes or improve function. In this study, patients with a presumed acute ischemic stroke were randomly assigned to receive candesartan (4 mg per day, n = 173) or placebo (n = 166) beginning on the first day. Candesartan is an angiotensin-II receptor antagonist. After the first seven days, patients receiving placebo also began receiving candesartan.
Eligible patients had a motor deficit, no signs of hemorrhage on computed tomography, and a mean of at least two blood pressure readings that was higher than 200/110 mm Hg at six to 24 hours after admission or higher than 180/105 mm Hg at 24 to 36 hours after admission. The authors do not disclose whether the allocation process was masked or whether they used an intention-to-treat analysis.
The primary outcomes, rates of case fatality and disability, were determined by evaluators who were masked to treatment. Members of the study's safety committee, who also were blinded to treatment, recommended that the study be stopped because of an excess of poor outcomes in one of the study arms. Fewer patients receiving candesartan died during the 12 months of follow-up, although the differences were not statistically significant (2.9 versus 7.2 percent in the control group). Fewer vascular events occurred in the candesartan group than in the control group (9.8 versus 18.7 percent;P =.026; number needed to treat = 11).
Bottom Line: This study ended early because patients with acute stroke who were receiving candesartan had fewer subsequent vascular events than patients receiving placebo. Because both groups received candesartan after the first week, all of the benefit logically could be attributed to one week of candesartan therapy in the acute poststroke period. Although fewer deaths occurred in the treated group, this number did not reach statistical significance. (Level of Evidence: 2b)