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The Study on Cognition and Prognosis in the Elderly (SCOPE): principal results of a randomized double-blind
Hans Lithell1, Lennart Hansson, Ingmar Skoog
1Department of Public Health and Caring Sciences, Sections of Geriatrics Clinical Hypertension Research and Family Medicine, University of Uppsala, Uppsala, Sweden. hans.lithell@pubcare.uu.se
Insights
Candesartan-based treatment in elderly patients with mild to moderate hypertension showed a non-significant reduction in major cardiovascular events but a significant decrease in non-fatal strokes. Cognitive function remained stable in both groups.
Area of Science:
- Cardiology
- Geriatrics
- Neurology
Background:
- Prognostic benefits of blood pressure lowering treatment in elderly hypertensive patients are established, but less clear for mild to moderate elevations.
- Elderly individuals with mild to moderate hypertension require further investigation regarding cardiovascular event reduction and cognitive health.
- Assessing the impact of specific antihypertensive therapies on cardiovascular outcomes and cognitive decline in older adults is crucial.
Purpose of the Study:
- To evaluate the efficacy of candesartan-based antihypertensive treatment in reducing cardiovascular events in elderly patients with mild to moderate hypertension.
- To determine if candesartan treatment impacts cognitive decline and the incidence of dementia in this population.
- To compare the effects of candesartan versus placebo on major cardiovascular events and cognitive function in older adults.
Main Methods:
- Prospective, double-blind, randomized, parallel-group study involving 4964 patients aged 70-89 years.
- Participants had mild to moderate hypertension (systolic 160-179 mmHg and/or diastolic 90-99 mmHg) and MMSE score ≥ 24.
- Patients received candesartan or placebo, with open-label active therapy added as needed; mean follow-up was 3.7 years.
Main Results:
- Candesartan led to a greater blood pressure reduction (21.7/10.8 mmHg) compared to control (18.5/9.2 mmHg).
- A non-significant 10.9% reduction in major cardiovascular events was observed with candesartan (P=0.19).
- Candesartan significantly reduced non-fatal stroke by 27.8% (P=0.04) and showed a trend for reducing all strokes (P=0.056); no differences in myocardial infarction or cardiovascular mortality were found.
- Cognitive function, assessed by MMSE, and dementia incidence were similar between groups.
Conclusions:
- Candesartan-based therapy in elderly hypertensive patients achieved slightly better blood pressure control, associated with a non-significant reduction in major cardiovascular events and a significant reduction in non-fatal stroke.
- Cognitive function was well-maintained in both treatment groups despite substantial blood pressure reductions.
- The study suggests that candesartan-based treatment is well-tolerated and beneficial for stroke prevention in elderly individuals with mild to moderate hypertension.
Background:
The prognostic benefits of blood pressure lowering treatment in elderly hypertensive patients were established more than a decade ago, but are less clear in those with mildly to moderately elevated blood pressure.
Objective:
To assess whether candesartan-based antihypertensive treatment in elderly patients with mildly to moderately elevated blood pressure confers a reduction in cardiovascular events, cognitive decline and dementia.
Design:
Prospective, double-blind, randomized, parallel-group study conducted in 1997-2002.
Setting And Participants:
The study was of 4964 patients aged 70-89 years, with systolic blood pressure 160-179 mmHg, and/or diastolic blood pressure 90-99 mmHg, and a Mini Mental State Examination (MMSE) test score >or= 24. A total of 527 centres in 15 countries participated in the study.
Intervention:
Patients were assigned randomly to receive the angiotensin receptor blocker candesartan or placebo, with open-label active antihypertensive therapy added as needed. As a consequence, active antihypertensive therapy was extensively used in the control group (84% of patients). Mean follow-up was 3.7 years.
Main Outcome Measures:
The primary outcome measure was major cardiovascular events, a composite of cardiovascular death, non-fatal stroke and non-fatal myocardial infarction. Secondary outcome measures included cardiovascular death, non-fatal and fatal stroke and myocardial infarction, cognitive function measured by the MMSE and dementia.
Results:
Blood pressure fell by 21.7/10.8 mmHg in the candesartan group and by 18.5/9.2 mmHg in the control group. A first major cardiovascular event occurred in 242 candesartan patients and in 268 control patients; risk reduction with candesartan was 10.9% [95% confidence interval (CI), -6.0 to 25.1, P = 0.19]. Candesartan-based treatment reduced non-fatal stroke by 27.8% (95% CI, 1.3 to 47.2, P = 0.04), and all stroke by 23.6% (95% CI, -0.7 to 42.1, P = 0.056). There were no significant differences in myocardial infarction and cardiovascular mortality. Mean MMSE score fell from 28.5 to 28.0 in the candesartan group and from 28.5 to 27.9 in the control group (P = 0.20). The proportions of patients who had a significant cognitive decline or developed dementia were not different in the two treatment groups.
Conclusions:
In elderly hypertensive patients, a slightly more effective blood pressure reduction during candesartan-based therapy, compared with control therapy, was associated with a modest, statistically non-significant, reduction in major cardiovascular events and with a marked reduction in non-fatal stroke. Cognitive function was well maintained in both treatment groups in the presence of substantial blood pressure reductions. Both treatment regimens were generally well tolerated.