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Atacand reduces risk of cardiovascular death in patients with chronic heart failure: study
Wilmington, Del. | Monday, September 1, 2003, 08:00 Hrs  [IST]

In the most comprehensive trial program to date with an angiotensin receptor blocker (ARB) for heart failure, AstraZeneca's Atacand (candesartan cilexetil), has been shown to improve survival in patients with chronic symptomatic heart failure (CHF), and diminished left ventricle (LV) function (LVEF < or = 40 per cent). The overall program results demonstrate that Atacand (n=1150) reduces cardiovascular (CV) deaths or hospital admissions for heart failure by 16 per cent when compared to placebo (n=1310) (p=<0.0001), across a broad spectrum of patients with symptomatic heart failure, irrespective of other concomitant heart failure therapies, ejection fraction, age or gender. Atacand is approved for the treatment of hypertension, it is not currently indicated for heart failure.

Findings from the clinical program known as CHARM (Candesartan in Heart failure Assessment of Reduction in Mortality and morbidity) were presented today at the annual meeting of the European Society of Cardiology Congress.

"CHARM is one of the most ambitious clinical trial programs in heart failure ever undertaken in terms of its scale and scope," said Marc Pfeffer, CHARM Co-Chairman, Professor of Medicine, Harvard Medical School, and Senior Physician, Brigham & Women's Hospital Boston, MA.

CHARM is an international, multi-center program involving 7,601 patients with classic symptoms of chronic heart failure and is comprised of three independent, parallel, double blind, placebo-controlled studies of Atacand: patients with left ventricular systolic dysfunction (LVEF < or = 40 per cent) in addition to standard therapy including an ACE inhibitor (CHARM Added); patients with LVEF < or = 40 per cent who are intolerant of ACE inhibitors (CHARM Alternative); and patients with preserved left ventricular systolic function (LVEF > 40 per cent) (CHARM Preserved). Patients were randomized to either Atacand or matching placebo initiated at 4 mg or 8 mg and titrated as tolerated to 32 mg once daily. All patients were followed for a minimum of two years.

In the CHARM program Atacand was generally well tolerated but associated with a greater occurrence of discontinuation of study medication compared to placebo due to an increase in serum creatinine (6.2 per cent vs. 3.0 per cent) hypotension (3.5 per cent vs. 1.7 per cent), and hyperkalemia (2.2 per cent vs. 0.6 per cent).

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