Atacand CHARM Study

AstraZeneca PLC 01 September 2003 NEW DATA DEMONSTRATES CLEAR BENEFITS OF ATACAND(R) IN TREATMENT OF SYMPTOMATIC HEART FAILURE Atacand(R), the only Angiotensin Receptor Blocker to reduce cardiovascular death and hospitalisation in chronic heart failure when given together with conventional therapy AstraZeneca announced today that data presented at the European Society of Cardiology annual meeting demonstrated Atacand(R) (candesartan cilexetil) reduces both cardiovascular deaths as well as hospital admissions for heart failure, across a broad spectrum of patients with chronic heart failure. Atacand is the only Angiotensin Receptor Blocker (ARB) to increase survival in chronic heart failure patients with left ventricular dysfunction, whether or not they are taking an ACE-inhibitor. 'This new data differentiates Atacand from other ARBs and provides AstraZeneca with a unique opportunity to make the benefits of the drug available to a wider population of patients with chronic heart failure' said Gunnar Olsson, AstraZeneca's Vice President Cardiovascular Therapy Area The Candesartan in Heart failure - Assessment of Reduction in Mortality and morbidity (CHARM) Programme, which recruited 7,601 patients, is the largest ever trial programme conducted in heart failure with an AT1-receptor blocker. Patients with classic symptomatic chronic heart failure - depressed left ventricular (LV) systolic function (Left Ventricular Ejection Fraction (LVEF) < 40 per cent), were randomised into one of two studies - either an ACE-inhibitor intolerant population (CHARM-Alternative), or the population treated with ACE-inhibitors (CHARM-Added). In addition, patients with preserved LV systolic function (LVEF> 40 per cent) were also randomised in a third study (CHARM Preserved). All patients received either Atacand or placebo. Atacand showed an overall 23 per cent reduction (p<0.0004) in risk of a cardiovascular(CV) death or hospitalisation for chronic heart failure(CHF) in patients who were not taking ACE inhibitors due to previous intolerance. This is comparable to the benefit seen in heart failure studies using ACE-inhibitors alone. In patients that were prescribed conventional therapy for chronic heart failure including an ACE inhibitor, Atacand demonstrated additional mortality and morbidity benefits. Atacand produced an additional reduction in the risk of cardiovascular death or hospitalisation for chronic heart failure of 15 per cent (p=0.011) when compared to conventional treatment alone. Importantly, Atacand demonstrated this efficacy, along with a high level of tolerability, when taken as part of triple combination therapy that included an ACE-inhibitor and beta-blocker - standard treatments in patients with chronic heart failure. The CHARM Programme also included the largest completed trial in chronic heart failure patients with preserved left ventricular function, patients for whom little evidence based treatment guidance presently exist. The primary endpoint of cardiovascular death or hospitalisations for chronic heart failure showed a trend, 11 per cent risk reduction in favour of Atacand (p=0.118), consistent with the significant findings seen in the other two studies. The total number of hospitalisations for CHF was significantly lower in the Atacand group (402 v 566). There was also a significant 40 per cent reduction in the number of patients diagnosed with new onset diabetes (47 v. 77; p=0.005). Pooled analysis of the three studies showed that Atacand provided a significant reduction in cardiovascular death and also demonstrated a positive trend in the overall reduction in all cause mortality approaching statistical significance (p =0.055). Interestingly, it also demonstrated a significant 22 per cent reduction in onset of new diabetes, with 163 new cases of diabetes on Atacand compared with 202 on placebo. Regulatory filings in the US and Europe based on the outcomes of the CHARM programme are anticipated during Q1 2004. Atacand, currently licensed for the treatment of hypertension, had sales of $569m worldwide in 2002. The CHARM study is due to be published in The Lancet on 6 September 2003. -Ends- September 1, 2003 Media Enquiries: Steve Brown, Tel: +44 (0) 207 304 5033 Chris Major, Tel: +44 (0) 207 304 5028 Investor Relations: Jonathan Hunt, Tel: +44 (0) 207 304 5087 Mina Blair-Robinson, Tel: +44 (0) 207 304 5084 This information is provided by RNS The company news service from the London Stock Exchange

Companies

AstraZeneca (AZN)
UK 100

Latest directors dealings