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
For more information, please visit www.astrazenecapressoffice.com
Following data presentation, AstraZeneca media materials will be available on www.astrazenecapressoffice.com, where further information on Atacand® can also be found.
Additional data at ACC:
AstraZeneca will be presenting important new data for Exanta, CRESTOR and Atacand during the ACC 2004.
Exanta SPORTIF III and V Studies. Monday 8 March, 16.00 - 17.30, Oral Presentation, MCC Convention Center, Room 265: B Olsson, Efficacy and Safety of Ximelagatran Compared with Well-Controlled Warfarin in Elderly Patients with Nonvalvular Atrial Fibrillation: Observations from the SPORTIF Trials. J Halperin, Efficacy and Safety of Ximelagatran Compared with Well-Controlled Warfarin in Women and Men with Nonvalvular Atrial Fibrillation in the SPORTIF Trials: 53rd Annual Scientific Session of the American College of Cardiology, New Orleans, USA, March 2004.
CRESTOR STELLAR Study, Monday 8th March, 14.00 - 15.00, Oral Presentation, MCC Convention Center, Room 217: P Deedwani, Comparative Effects of Statins on Atherogenic Dyslipidaemia in Patients With the Metabolic Syndrome: 53rd Annual Scientific Session of the American College of Cardiology, New Orleans, USA, March, 2004
Atacand CHARM Programme:
Monday 8 March, Morning Session, Poster Session, MCC Convention Center: Scott Solomon et al., Cause of Death Across Full Spectrum of Ventricular Function in Patients with Heart Failure: The CHARM Study: 53rd Annual Scientific Session of the American College of Cardiology, New Orleans, USA, March 2004.
Monday 8 March, 11.00 - 12.15, Oral Presentation, Session Number 810, MCC Convention Center: Salim Yusuf et al., Impact of the Angiotensin-Receptor Blocker Candesartan in Preventing Diabetes in Patients With Heart Failure: 53rd Annual Scientific Session of the American College of Cardiology, New Orleans, USA, March 2004.
Monday 8 March, 15.00 - 17.00, Poster Session, Session Number 1108, MCC Convention Center: John McMurray et al., Low Hemoglobin is an Independent Predictor of Adverse Fatal and Non Fatal outcomes in Both Reduced and Preserved Systolic Function Chronic Heart Failure: findings from the Candesartanin Heart failure: Assessment of Reduction in Mortality and morbidity Programme (CHARM): 53rd Annual Scientific Session of the American College of Cardiology, New Orleans, USA, March 2004.
Tuesday 9 March, 08.30 - 10.00, Oral Presentation, Session Number 835, MCC Convention Center: John McMurray et al., Candesartan Improves Functional Class Across a Broad Spectrum of Patients With Chronic Heart Failure: Results of the Candesartan in Heart Failure- Assessment of Reduction in Mortality and Morbidity Programme (CHARM): 53rd Annual Scientific Session of the American College of Cardiology, New Orleans, USA, March 2004.
Tuesday 9 March, 12.00 - 14.00, Poster Session, Session Number 1145, MCC Convention Center: Karl Swedberg et al., Prevention of AF in Symptomatic Chronic Heart Failure by Candesartan - Results From CHARM: 53rd Annual Scientific Session of the American College of Cardiology, New Orleans, USA, March 2004
References
1. John J. McMurray, Jan Östergren, Bertil Olofsson, et al. Candesartan improves functional class across a broad spectrum of patients with chronic heart failure: Results of the Candesartan in Heart Failure- Assessment of Reduction in Mortality and Morbidity Programme (CHARM). Presented at the American College of Cardiology annual conference on Tuesday, 9 March 2004; 9:30 AM - 9:45 AM
2. Karl Swedberg, Marc Pfeffer, Alain Cohen-Solal, et al. Prevention of AF in Symptomatic Chronic Heart Failure by Candesartan - Results From CHARM. Presented at the American College of Cardiology annual conference on Tuesday, 9 March 2004; 1.00 PM – 2PM.
3. Salim Yusuf, Jan B. Ostergren, Hertzel Gerstein, et al. Impact of the Angiotensin-Receptor Blocker Candesartan in Preventing Diabetes in Patients With Heart Failure. Presented at the American College of Cardiology annual conference on Monday, 8 March 2004; 11:00 AM -11:15 AM
Notes to editors
Class I: No limitation. Ordinary physical exercise does not cause fatigue, dyspnoea (breathlessness) or palpitations
Class II: Slight limitation of physical activity. Comfortable at rest but ordinary physical activity results in symptoms
Class III: Marked limitation of physical activity. Comfortable at rest but less than ordinary activity results in symptoms
Class IV: Unable to carry out any physical activity without discomfort. Symptoms present even at rest with increased discomfort with any physical activity