New data on the effect of Atacand(R) on NYHA class in a broad spectrum of heart failure patients

03/08/04

Mölndal, Sweden, 9 March 2004 – Data presented today at the American College of Cardiology (ACC) annual meeting add weight to the evidence shown in the original publications from the CHARM* Programme of the effects of Atacand (candesartan cilexetil) in chronic heart failure (CHF) patients. The results from further analysis of the data add further support for the CHARM study as a landmark clinical research programme.

Importantly, one analysis1 found that New York Heart Association (NYHA) functional class improved in a broad spectrum of CHF patients treated with Atacand. Of all CHARM patients, 35.4% taking Atacand improved in NYHA functional class, 55.6% remained unchanged and 9% worsened. This compared with 32.5%, 57.5% and 10.3% respectively in the placebo group (p=0.004). These findings were supported by a favourable change in the Overall Treatment Evaluation in the Atacand group compared to the placebo group (p=0.01).

Commenting on this additional analysis, Professor John McMurray, principal investigator in the CHARM-Added study, Glasgow University and Western Infirmary, Glasgow, Scotland, said "Improving symptomatic well-being is a key objective of heart failure treatment. NYHA functional classification is the most widely used and validated measure of symptomatic limitation in CHF. That candesartan has been shown to improve NYHA functional class across the broad spectrum of CHF investigated in the CHARM Programme will have significant implications for clinical practice. These findings are consistent with a reduction in CHF hospitalisations".

A further analysis suggests that the development of atrial fibrillation (AF) in some patients with symptomatic chronic heart failure may also be reduced. Of the 7,601 heart failure patients in CHARM, 72.6% did not have atrial fibrillation (AF) at baseline. This new analysis found that, in the patients randomised to Atacand, new incidence of AF during the trial was 6.5%, compared to 7.9% in the placebo group (p=0.048), indicating that Atacand may prevent the development of AF in some patients with symptomatic chronic heart failure.

A similar analysis3 showed that, during the CHARM Programme, the number of patients who were newly diagnosed as having Type II diabetes mellitus (6.0% on Atacand compared to 7.4% on placebo; p=0.020) was significantly lower in the group treated with Atacand. Commenting on the presentations, CHARM co-chairman, Professor Karl Swedberg, Göteborg University and Sahlgrenska University Hospital/Östra, Göteborg, Sweden, said: "CHARM was a unique programme which found that candesartan reduced both cardiovascular death and hospital admission in a broad spectrum of heart failure patients. These additional findings add further evidence to the clinical effectiveness of candesartan in heart failure."

Based on the results of the CHARM Programme, AstraZeneca expects to submit regulatory application for the use of Atacand in heart failure during the second quarter 2004.

*Candesartan in Heart failure - Assessment of Reduction in Mortality and morbidity (CHARM) study programme

Source: Eurekalert & others

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