Atacand(R) proven to prevent stroke in the elderly
SCOPE study demonstrates benefits in pre-specified analysis in the group of patients with isolated systolic hypertension (ISH)
FOR NON-US MEDIA ONLY: Embargoed 11.15 EST (17.15 CET), 10 November 2003
(Orlando, 10 November 2003) – Data presented today at the American Heart Association (AHA) annual meeting highlight the potential of Atacand® (candesartan cilexetil) in reducing the incidence of stroke in elderly patients with isolated systolic hypertension (ISH).
Data from a pre-specified analysis in the group of patients with ISH, demonstrate a dramatic 42% relative risk reduction (p=0.05) in fatal/non-fatal strokes in the Atacand group compared to the control group, despite little difference in blood pressure lowering.
A total of 4,964 patients aged 70-89 years with systolic blood pressure 160-179 mmHg, or diastolic blood pressure 90-99 mmHg were enrolled in the SCOPE* study. Patients were then randomly assigned to double-blind candesartan or placebo with standard open-label anti-hypertensive therapy added as needed to control blood pressure. 1,518 of these patients had ISH (SBP > 160 and DBP <90 mmHg).
"ISH is the predominant form of hypertension in the elderly, with stroke the most common cardiovascular complication in this age group. These results demonstrate that reducing blood pressure with Atacand offers important clinical benefit by reducing the risk of stroke in this patient group", comments Professor Papademetriou, Professor of Medicine, Department of Cardiology, Georgetown University, Washington, DC.
The study showed that a total of 20 strokes (3 fatal, 17 non-fatal) occurred in the Atacand treatment group, whereas 35 (7 fatal, 28 non-fatal) occurred in the control group. The study revealed similar reductions in blood pressure in the two groups; blood pressure fell by 22/6 mmHg in the Atacand group and 20/5 mmHg in the control group.
Hypertension is reported to affect about 20% of adults around the world and is considerably higher in the elderly (>60 years), with an estimated prevalence of more than 50%1. ISH is the most common form of hypertension in the elderly accounting for approximately two thirds of all cases of hypertension among these individuals2,3,4.
ISH has been shown to increase cardiovascular morbidity and all-cause mortality two-fold or more and can triple cardiovascular mortality5. Hypertension remains the single most important risk factor for stroke6.
"These data show Atacand to offer real benefits to patients at risk of stroke due to ISH and further add to the body of evidence for Atacand in reducing CV mortality and morbidity," comments Anders Svensson, VP Medical Director, Cardiovascular Therapy Area. "We are pleased to have worked with the SCOPE study group on this project."
Atacand has an established track record in blood pressure reduction with proven efficacy and placebo-like tolerability. SCOPE is one of a number of large-scale trials and complements the recent announcement of the CHARM* data at this year's European Society of Cardiology congress. CHARM demonstrates the clear benefits of Atacand in the treatment of symptomatic heart failure, both in patients taking an ACE-inhibitor and/or other conventional therapy, and in those who cannot take an ACE-inhibitor. DIRECT*, a study investigating Atacand in diabetic retinopathy, is due to report in 2006/7.
* Trial Acronyms: SCOPE = Study on COgnition and Prognosis in the Elderly CHARM = Candesartan in Heart failure - Assessment of Reduction in Mortality and morbidity (CHARM) study programme DIRECT = Diabetic Retinopathy Candesartan Trials
Lisa Marriott Ketchum, London office Mobile: 44-7949-412-236 Office: 44-207-611-3691 Email: lisa.marriott@ketchum.com
Notes to editors
The Study on COgnition and Prognosis in the Elderly (SCOPE)
Enrolled 4,937 patients aged 70-89 years from 15 countries
AstraZeneca is the sole sponsor of the SCOPE study. Patients were randomised to either Atacand® or placebo
The primary endpoint of SCOPE assessed the effect of Atacand® on major cardiovascular events. These are defined as cardiovascular death, non-fatal myocardial infarction (MI) and non-fatal stroke.
The secondary endpoints for the study focussed on the effects of Atacand® on cognitive function, dementia, total mortality, cardiovascular mortality, MI stroke, renal function, diabetes, hospitalisation, quality of life and health economics.
Candesartan Cilexetil is marketed by AstraZeneca under trademark Atacand®. Atacand® is manufactured under agreement from Takeda Chemical Industries Ltd
References
1. World Health Organisation. The World Health Report 1997. Geneva, 1997 2. Ostfield, Adrain M, et al. Chapter 10: Epidemiology and treatment of hypertension in older persons, Hypertension: Pathophysiology, Diagnosis and Management, 2nd edition, p. 145-157, Raven Press, Ltd., New York, 1995. 3. Franklin, Stanley S, et al. Predominance of isolated systolic hypertension among middle-aged and elderly US Hypertensives, Hypertension, 37(3):869-878, 2001. 4. Franklin SS, Jacobs MJ, Wong ND, et al. Predominance of isolated systolic hypertension among middle-aged and elderly US hypertensives: analysis based on the National Health and Nutrition Examination Survey (NHANES) III. Hypertension. 2001;37:869-874. 5. Farsang C, et al. European Society of Hypertension Scientific Newsletter: Update on Hypertension Management, 2:6, 2001 6. American Heart Association website. http://www.strokeassociation.org/presenter.jhtml?identifier=1060
