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CLINICAL RESEARCH: CLINICAL TRIALS

Stroke prevention with the angiotensin II type 1-receptor blocker candesartan in elderly patients with isolated systolic hypertension

The study on cognition and prognosis in the elderly (SCOPE)

Vasilios Papademetriou, MD^*,*, Csaba Farsang, MD, Dag Elmfeldt, MD^,, Albert Hofman, MD^||, Hans Lithell, MD, Bertil Olofsson, MD, Ingmar Skoog, MD^¶, Peter Trenkwalder, MD^#, Alberto Zanchetti, MD^** for the SCOPE Study Group

^* Hypertension and Cardiovascular Research, Veterans Administration Medical Center, Washington, DC, USA
First Department of Internal Medicine St. Emeric Teaching Hospital, Budapest, Hungary
Department of Public Health and Caring Sciences, Sections of Geriatrics, Clinical Hypertension Research and Family Medicine, University of Uppsala, Uppsala, Sweden
^|| Departments of Epidemiology and Biostatistics, Erasmus University Medical School, Rotterdam, the Netherlands
Clinical Science, Medicine and Biostatistics, AstraZeneca R&D, Mölndal, Sweden
^¶ Institute of Clinical Neurosciences, Neuropsychiatric Epidemiology Unit, Sahlgrenska Academy, Göteborg University, Göteborg, Sweden
^# Department of Internal Medicine, Starnberg Hospital, Ludwig Maximilian University Munich, Starnberg, Germany
^** Centro di Fisiologia Clinica e Ipertensione, University of Milan and Istituto Auxologico Italiano, Milan, Italy

Manuscript received February 15, 2004; revised manuscript received June 3, 2004, accepted June 7, 2004.

^* Reprint requests and correspondence: Dr. Vasilios Papademetriou, Director, Hypertension & Cardiovascular Research, Co-Director, Cardiac Catheterization Laboratory, Veterans Administration Medical Center, 50 Irving Street NW 151E, Washington, DC 20422 (Email: papavip{at}aol.com).

OBJECTIVES: The aim of this study was to test the hypothesis that the angiotensin II type 1 receptor blocker (ARB) candesartan can reduce the risk of stroke in elderly patients with isolated systolic hypertension (ISH).

BACKGROUND: Isolated systolic hypertension is the predominant form of hypertension in the elderly, and stroke is the most common cardiovascular (CV) complication.

METHODS: In the Study on Cognition and Prognosis in the Elderly (SCOPE), 4,964 patients age 70 to 89 years were randomly assigned to double-blind candesartan or placebo with open-label antihypertensive therapy (mostly thiazide diuretics) added as needed to control blood pressure. Of the 4,964 patients, 1,518 had ISH (systolic blood pressure >160 mm Hg and diastolic blood pressure <90 mm Hg). The present study is a predefined subgroup analysis of outcome results in the ISH patients.

RESULTS: Of the ISH patients, 754 were randomized to the candesartan group and 764 to the control group. Over the study period, blood pressure was reduced by 22/6 mm Hg in the candesartan group and by 20/5 mm Hg in the control group (difference between treatments 2/1 mm Hg; p = 0.101 and 0.064). A total of 20 fatal/non-fatal strokes occurred in the candesartan group (7.2/1,000 patient-years) and 35 in the control group (12.5/1,000 patient-years); relative risk (RR) was 0.58 (95% confidence interval 0.33 to 1.00), that is, a RR reduction of 42% (p = 0.050 unadjusted, p = 0.049 adjusted for baseline risk). There were no marked or statistically significant differences between the treatment groups in other CV end points or all-cause mortality.

CONCLUSIONS: In elderly patients with ISH, antihypertensive treatment based on the ARB candesartan resulted in a significant 42% RR reduction in stroke in comparison with other antihypertensive treatment, despite little difference in blood pressure reduction.

Abbreviations and Acronyms   ARB = angiotensin II type 1 receptor blocker   AT1 = angiotensin II type 1   CI = confidence interval   CV = cardiovascular   DBP = diastolic blood pressure   HCTZ = hydrochlorothiazide   ISH = isolated systolic hypertension   LIFE = Losartan Intervention For Endpoint reduction study   MMSE = Mini Mental State Examination   RR = relative risk   SBP = systolic blood pressure   SCOPE = Study on Cognition and Prognosis in the Elderly

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