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Amias® (candesartan cilexetil), an antihypertensive drug, now shows clear benefits in symptomatic heart failure

August 31, 2003

Amias® (candesartan cilexetil), an antihypertensive drug, now shows clear benefits in symptomatic heart failure

CHARM Study Programme demonstrates that Amias® saves lives and reduces hospitalisation in heart failure, irrespective of background therapy

European Society of Cardiology, Vienna, 31st August 2003 - Exciting results from the largest study of an angiotensin receptor blocker (ARB) in the treatment of heart failure - the CHARM (Candesartan in Heart failure - Assessment of Reduction in Mortality and morbidity) Study Programme - were presented today revealing that Amias (candesartan cilexetil) reduces cardiovascular deaths and hospital admissions, irrespective of background therapy.

The landmark study results also demonstrated that candesartan is the first ARB to increase survival in chronic heart failure patients with left ventricular systolic dysfunction, whether or not they are taking an ACE-inhibitor with or without a beta-blocker. Candesartan, one of the leading ARBs used in the treatment of hypertension, now has evidence of benefits for a broad spectrum of patients with chronic heart failure.

The results of CHARM(1), which involved 7,601 patients, will influence the way that clinicians treat heart failure. Heart failure has an extremely poor prognosis with 40% of patients dying within the first year of diagnosis which is worse than many common cancers(2), and new evidence for a treatment that can improve outcomes will be important to clinicians and patients.

Commenting on the study, Professor John McMurray, a principal investigator in the CHARM Study Programme, Glasgow University and Western Infirmary, Glasgow, Scotland said: "The results of the CHARM programme mean that we can improve the outlook for three groups of patients with heart failure. Around 10% of patients with a reduced LVEF cannot tolerate ACE inhibitors, known to be life-saving in this condition. CHARM-Alternative now provides new hope for these patients. Even with the best available treatment for the majority of patients with CHF and a low LVEF (an ACE inhibitor and beta-blocker) the prognosis remains very poor. CHARM-Added shows that this can now be improved with candesartan. Finally, for the substantial minority of patients with CHF and no major reduction in LVEF, CHARM-Preserved offers the first evidence that any treatment can reduce the risk of hospitalisation with worsening CHF."

His words were echoed by Professor Martin Cowie, Professor of Cardiology at the Brompton Hospital, London: "The recent NICE guidance to the NHS on heart failure correctly anticipated that the CHARM Study results might influence treatment recommendations. For the first time we have robust evidence that candesartan cilexetil, an angiotensin receptor blocker, can be a beneficial alternative for patients who cannot tolerate an ACE inhibitor. Moreover, the CHARM results show the additional benefit of using candesartan in addition to an ACE inhibitor and beta-blocker, when previous studies had suggested this combination had adverse effects. The challenge is now to ensure that this new evidence is translated into practice as rapidly as possible."

Given that candesartan is currently licensed for the treatment of hypertension, the results of the CHARM Study Programme are especially important because heart failure is common among patients with raised blood pressure. The positive outcome of the CHARM Study Programme in heart failure will, therefore, undoubtedly have an impact on the treatment of hypertension because it will provide doctors with reassurance about the use of candesartan in this patient population.

In the CHARM Study Programme, patients with classic symptomatic chronic heart failure - depressed left ventricular (LV) systolic function, defined as a left ventricular ejection fraction (LVEF) less than 40%, were entered into one of two randomised trials - one comprising an ACE-inhibitor intolerant population (CHARM-Alternative), the other a population treated with ACE-inhibitors (CHARM-Added). In addition, a third trial consisted of patients with symptomatic heart failure but preserved LV systolic function, defined as a left ventricular ejection fraction (LVEF) greater than 40% (CHARM-Preserved). All patients received either candesartan or placebo.

CHARM-Alternative
In the CHARM-Alternative trial, candesartan significantly reduced the risk of cardiovascular death or hospitalisation for chronic heart failure. The overall risk reduction was 23% (p=0.0004) - comparable to the benefit seen in heart failure studies using ACE inhibitors.

CHARM-Added
Patients with heart failure who were prescribed candesartan, in addition to conventional therapy, showed a significant risk reduction of 15% (p=0.011) in cardiovascular death or hospitalisation. These results are in contrast to a previous study of another ARB which had suggested a triple combination of an ACE-inhibitor, ARB and beta-blocker may be associated with adverse outcomes. The results from CHARM show that candesartan is effective as part of a triple combination therapy.

CHARM-Preserved
The CHARM Study Programme also included the largest completed study of chronic heart failure patients with preserved LV function, patients for whom little evidence-based guidance regarding treatment exists. In this study the primary endpoint of cardiovascular death or hospitalisation for chronic heart failure showed a trend toward risk reduction of 11% in favour of candesartan.

Pooled Analysis
In the broad spectrum of patients with symptomatic heart failure involved in the CHARM study programme, overall, the pooled analysis from the three trials showed that Amias® demonstrated a positive trend in the reduction of all cause mortality.


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