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.


METHODS
Post-hoc analysis of a prospective, randomized, controlled trial.


METHODS
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.


METHODS
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.


METHODS
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.
Lithell
Hans
H
Department of Public Health and Caring Sciences, Section of Geriatrics, University of Uppsala, Sweden. hans.lithell@pubcare.uu.se
Hansson
Lennart
L
Skoog
Ingmar
I
Elmfeldt
Dag
D
Hofman
Albert
A
Olofsson
Bertil
B
Trenkwalder
Peter
P
Zanchetti
Alberto
A
D000368:Aged; D000959:Antihypertensive Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001562:Benzimidazoles / Q000008:administration & dosage* / Q000009:adverse effects; D001713:Biphenyl Compounds; D001794:Blood Pressure / Q000187:drug effects; D002318:Cardiovascular Diseases / Q000401:mortality; D003071:Cognition; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006973:Hypertension / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D011379:Prognosis; D011446:Prospective Studies; D020379:Risk Adjustment; D013777:Tetrazoles / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
D000959:Antihypertensive Agents; D001562:Benzimidazoles; D001713:Biphenyl Compounds; D013777:Tetrazoles; C081643:candesartan