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Early Intervention with Atacand (Candesartan) Improves Outcome for Patients with Acute Ischaemic Stroke

LONDON, UK -- July 28, 2003 -- Results of the ACCESS trial show that Atacand® (candesartan cilexetil**) reduced the number of vascular events by 45% during 12 months following acute stroke in patients with elevated blood pressure.

These data revealed that the cumulative 12-month mortality was 2.9% for Atacand versus 7.2% for placebo (P=0.07), while the rate of vascular events post stroke was nearly half with Atacand compared with placebo (9.8% compared with 18.7%, P=0.026). The cumulative 12-month mortality and the number of vascular events differed significantly in favour of the Atacand group (odds ratio, 0.475; 95% CI, 0.252 to 0.895). Crucially, the trial found that a 7 day course of Atacand when initiated no later than 72 hours post stroke significantly improved cardiovascular morbidity and mortality.

"The ACCESS data clearly defined the benefit and safety of early AT1-antagonist intervention with Atacand for patients suffering from acute ischaemic stroke", commented lead investigator Prof Peter Dominiak, Lübeck University, Germany. "These data have great implications for the management of stroke patients in the future."

Atacand demonstrated a tolerability and side effect profile comparable to placebo. Importantly, no cardiovascular or cerebrovascular event occurred as a result of low blood pressure due to Atacand treatment.

Stroke is the third most common cause of death in industrialised countries and a leading cause of adult disability^{(1, 2, 3)} Each year, stroke affects nearly 20 million people worldwide and of these, approximately five million people die. Stroke cost the USA $51.2 billion in direct and indirect costs in 20032 and costs the UK's NHS over £2.3 billion a year.⁽⁴⁾

Atacand is a selective angiotensin II type 1 (AT1) receptor blocker and is the first antihypertensive therapy to show a benefit with early treatment for acute ischaemic stroke in patients with high blood pressure.

Atacand® is a trademark of the AstraZeneca group of companies.

* The ACCESS study (Acute Candesartan Cilexetil Evaluation in Stroke Survivors) is a double-blind, placebo-controlled, randomised, multicentre phase II study with 342 patients (339 valid for statistical evaluation) across Germany, evaluating the use of Atacand® in acute stroke patients with high blood pressure. The study was designed to assess the safety of modest blood pressure reduction 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.

** Candesartan cilexetil is an AT1-receptor blocker which was discovered by Takeda Chemical Industries, Ltd. And has been developed jointly by AstraZeneca and Takeda. The product is now available in most countries under the trade names Atacand® and/or Blopress® by AstraZeneca and Takeda respectively.

References

1 The European Stroke Initiative. Introduction to the management of stroke - How frequent are strokes? 2003 www.eusi-stroke.com

2 American Heart Association, Heart Disease and Stroke Statistics – 2003 Update
www.americanheart.org/presenter.jhtml?identifier=3009972

3 MacMahon S, Neal B, Tzourio C, Rodgers A, Woodward M, Cutler J, et al. (the PROGRESS Collaborative Group). Randomised trial of a perindopril – based blood pressure-lowering regimen among 6105 individuals with previous stroke or transient ischaemic attack. Lancet 2001;358:1033-1041

4 The Stroke Association www.stroke.org.uk


SOURCE: AstraZeneca.

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