Rationale, design and methods of the OSCAR study: observational study on cognitive function and systolic blood pressure reduction in hypertensive patients

Abstract

Data from several recent clinical trials have suggested a beneficial effect of antihypertensive medications on preservation of cognitive function. Eprosartan, an angiotensin type-1 receptor antagonist (ARA) with dual action on both pre- and postsynaptic angiotensin type 1 receptors, may be effective in the control of SBP and the prevention of cognitive decline. The OSCAR (Observational Study on Cognitive function And SBP Reduction) study is an international longitudinal observational study with a duration of 6 months intended to examine the impact of the ARA eprosartan on cognitive function (assessed using the Mini-Mental State Examination [MMSE]) and control of systolic blood pressure (SBP) in a large international population of hypertensive patients managed in a standard primary care setting. A total of 100,000 hypertensive patients, aged >or=50 years and with SBP of >140 mmHg will be recruited by more than 20 000 primary care physicians in 27 countries. These patients will receive eprosartan 600 mg once a day for 6 months. The MMSE, a globally validated cognitive screening test, will be performed at baseline, and after 6 months of treatment. After the first month of monotherapy, eprosartan treatment may, at the absolute discretion of individual investigators, be supplemented with other antihypertensive medications for the remainder of the study. The primary outcome indices are the mean relative change in MMSE score and the absolute change from baseline in SBP in the study population as a whole and in subsets of patients according to various factors among them: ethnicity, comorbidities (i.e. target organ damage, diabetes), baseline cognitive level and baseline blood pressure level. The secondary objectives are to identify factors influencing SBP and MMSE changes. The OSCAR trial is the first international observational study focusing on MMSE in a wide international cohort of hypertensive patients. The results are expected in 2007.