The ACCESS Study: evaluation of Acute Candesartan Cilexetil Therapy in Stroke Survivors.
OBJECTIVE
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.
Schrader
Joachim
J
Department of Internal Medicine, St Josefs Hospital Cloppenburg, Germany. j.schrader@kh-clp.de
Lüders
Stephan
S
Kulschewski
Anke
A
Berger
Jürgen
J
Zidek
Walter
W
Treib
Johannes
J
Einhäupl
Karl
K
Diener
Hans Christoph
HC
Dominiak
Peter
P
D000208:Acute Disease; D000368:Aged; D057911:Angiotensin Receptor Antagonists; D000959:Antihypertensive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001562:Benzimidazoles / Q000009:adverse effects / Q000627:therapeutic use*; D001713:Biphenyl Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D001794:Blood Pressure / Q000187:drug effects; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D016017:Odds Ratio; D011446:Prospective Studies; D044140:Receptor, Angiotensin, Type 1; D012449:Safety; D020521:Stroke / Q000175:diagnosis / Q000188:drug therapy*; D016019:Survival Analysis; D017741:Survivors / Q000706:statistics & numerical data; D013777:Tetrazoles; D013995:Time; D016896:Treatment Outcome
D057911:Angiotensin Receptor Antagonists; D000959:Antihypertensive Agents; D001562:Benzimidazoles; D001713:Biphenyl Compounds; D044140:Receptor, Angiotensin, Type 1; D013777:Tetrazoles; C077793:candesartan cilexetil