New CHARM* analysis adds further weight to effectiveness of Atacand® in treating heart failure

08/27/04

Atacand® is proven to reduce deaths and hospitalisation in patients with heart failure and reduced left ventricular ejection fraction

Embargoed until 08.30 CET, Munich, Germany, 31 August 2004: Data presented today at the European Society of Cardiology (ESC) Congress reinforces the benefits of Atacand® (candesartan cilexetil) in patients with chronic heart failure (CHF) and reduced left ventricular ejection fraction (LVEF). The data demonstrated a significant reduction in deaths and CHF hospital admissions in favour of Atacand®, adding further support to the previously presented results from the entire CHARM Programme1 on the effects of Atacand® in a broad spectrum of CHF patients.

A pre-specified analysis2 in the group of CHARM patients with heart failure and reduced LVEF (n=4576; LVEF = 40%), the higher risk population most frequently studied in previous heart failure clinical trials, demonstrated a 12% relative risk reduction in all cause deaths (p=0.018) and a 16% relative risk reduction in cardiovascular deaths (p=0.005) when Atacand® was added to standard treatment. With 29 deaths avoided per 1,000 treated patients investigators concluded that Atacand® should be considered in all patients with CHF and a low LVEF. This new analysis also shows a 24% relative risk reduction in CHF hospital admissions (p<0.001). The effect of treatment with Atacand® was similar irrespective of background treatment with ACE-inhibitors, beta blockers or spironolactone.

"This data clearly shows the benefits of treatment with Atacand® irrespective of other background life-saving therapies for these very sick patients" comments CHARM co-chairman, Professor Karl Swedberg, Göteborg University and Sahlgrenska University Hospital/Östra, Göteborg, Sweden. "Patients with heart failure and reduced left ventricular ejection fraction - the 'classic' heart failure population studied in major clinical trials - have a high risk of cardiovascular death and hospitalisation. The CHARM data shows that Atacand® can offer these patients a significant improvement by reducing mortality and improving symptoms, resulting in fewer hospital admissions".

The CHARM Programme consisted of three component trials comparing the angiotensin II type 1 (AT1) receptor blocker Atacand® to placebo. Two trials randomised patients with LVEF = 40%; the CHARM Alternative Trial3 (ACE – inhibitor intolerant patients) and the CHARM Added Trial4 (all patients on ACE-inhibitors) comprising a total of 4,576 patients with an average age of 65 years and a mean LVEF of 29%.

CHF is the only major cardiovascular disease with increasing incidence and prevalence and is a major public health problem. CHF continues to place a significant burden on patients and healthcare systems worldwide. As a major cause of death, hospital admissions and poor quality of life, CHF is believed to affect in the region of 1-2% of the general population5,6, rising to 8% in people over the age of 75 years7.

Atacand® is an angiotensin II type 1 (AT1) receptor blocker indicated for the treatment of high blood pressure. As a proven and leading antihypertensive therapy, Atacand® was first licensed in 1997 and has been shown to lower blood pressure more effectively than losartan, the first marketed member of the class8,9,10,11. Recent clinical outcome studies with SCOPE and CHARM, have demonstrated the clinical value of Atacand® in treating hypertension and heart failure. In April, AstraZeneca filed a regulatory application in the European Union (EU), as part of the Mutual Recognition Variation Procedure to obtain a new indication for Atacand® (candesartan cilexetil) for use in the treatment of heart failure. An application was filed in the US on June 30 and further filings in other markets are expected in the near future.

Source: Eurekalert & others

Last reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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