Stroke. 2003;34:1699-1703
Published online before print June 19, 2003, doi: 10.1161/01.STR.0000075777.18006.89
Published online before print June 19, 2003, doi: 10.1161/01.STR.0000075777.18006.89
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(Stroke. 2003;34:1699.)
© 2003 American Heart Association, Inc.
Original Contributions |
The ACCESS Study
Evaluation of Acute Candesartan Cilexetil Therapy in Stroke Survivors
From the Department of Internal Medicine, St Josefs Hospital Cloppenburg (J.S., S.L., A.K.); Institute for Mathematics and Medical Statistics, University Hamburg-Eppendorf (J.B.); Department of Nephrology, Klinikum Benjamin Franklin, Freie Universität Berlin (W.Z.); Department of Neurology, Westpfalz Klinikum Kaiserslautern (J.T.); Department of Neurology, Charité, Humbold University Berlin (K.E.); Department of Neurology, University of Essen (H.C.D.); and Department of Pharmacology and Toxicology, University of Lübeck (P.D.), Germany.
Correspondence to Dr Joachim Schrader, St Josefs Hospital, Krankenhausstrasse 13, D-49661 Cloppenburg, Germany. E-mail j.schrader{at}kh-clp.de
Background and Purpose— The Acute Candesartan Cilexetil Therapy in Stroke Survivors (ACCESS) study was designed to assess the safety of modest blood pressure reduction by candesartan cilexetil in the early treatment of stroke. The study was also designed to provide an estimate of the number of cases required to perform a larger phase III efficacy study.
Methods— Five hundred patients were recruited in a prospective, double-blind, placebo-controlled, randomized, multicenter phase II study.
Results— This safety trial was stopped prematurely when 342 patients (339 valid) had been randomized because of an imbalance in end points. Demographic data, cardiovascular risk factors, and blood pressure on admission, on study onset, and within the whole study period were not significantly different between the 2 groups. However, the cumulative 12-month mortality and the number of vascular events differed significantly in favor of the candesartan cilexetil group (odds ratio, 0.475; 95% CI, 0.252 to 0.895). There were no significant differences in concomitant medication and in number or type of side effects.
Conclusions— Although the mechanisms by which angiotensin type 1 (AT1) receptor blockade affects cardiovascular morbidity and mortality are still unresolved, the present study shows that early neurohumoral inhibition has similar beneficial effects in cerebral and in myocardial ischemia. The fact that no cardiovascular or cerebrovascular event occurred as a result of hypotension is of significant clinical importance. When there is need for or no contraindication against early antihypertensive therapy, candesartan cilexetil is a safe therapeutic option according to the ACCESS results.
Key Words: antihypertensive therapy • benzimidazoles • blood pressure • stroke, acute
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