The Study on COgnition and Prognosis in the Elderly (SCOPE); outcomes in patients not receiving add-on therapy after randomization

Objective: To assess clinical outcomes in the Study on COgnition and Prognosis in the Elderly (SCOPE) in patients who did not receive add-on antihypertensive therapy after randomization, i.e. in patients that best reflect the original intention of a placebo-controlled trial. Design: Post-hoc analysis of a prospective, randomized, controlled trial. Settings and participants: Five hundred and twenty-seven centres in 15 countries participated in SCOPE. Patients aged 70-89 years, with systolic blood pressure 160-179 mmHg and/or diastolic blood pressure 90-99 mmHg, and preserved cognitive function were eligible. Out of 4937 patients in SCOPE, 2098 did not receive add-on therapy. Intervention: The number of patients who received candesartan 8-16 mg once daily was 1253, and 845 received placebo. Mean follow-up was 3.7 and 3.5 years, respectively. Main outcome measures: Primary: major cardiovascular events (cardiovascular mortality, non-fatal stroke or non-fatal myocardial infarction). Secondary: total mortality, cardiovascular mortality, fatal and non-fatal myocardial infarction, fatal and non-fatal stroke, cognitive function, and dementia. Results: The treatment groups were generally well balanced for baseline characteristics. Blood pressure fell by 21.8/11.0 mmHg in the candesartan group and by 17.2/ 8.4 mmHg in the placebo group. There were significant relative risk reductions with candesartan in major cardiovascular events (32%, P = 0.013), cardiovascular mortality (29%, P = 0.049), and total mortality (27%, P = 0.018). There were no significant differences between the treatment groups in cognitive outcomes. Both treatments were generally well tolerated. Conclusions: Treatment of elderly patients with mild hypertension is beneficial and supports current recommendations. Candesartan appears an appropriate therapy in such patients, in view of its favourable tolerability profile and ability to reduce major cardiovascular events.