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Clinical Question
Does long-term blood pressure lowering and lipid lowering prevent cognitive decline in the elderly?
Bottom line
In this randomized trial, after a median of 5.7 years of follow-up, lowering blood pressure with candesartan/hydrochlorothiazide and lowering cholesterol with rosuvastatin had no meaningful effect on cognition or function in the elderly. 1b
Reference
Study design: Randomized controlled trial (double-blinded)
Funding: Industry + govt
Setting: Outpatient (any)
Synopsis
This report presents the long-term follow-up results from a subgroup of the Heart Outcomes Prevention Evaluation-3 (HOPE-3) trial. HOPE-3 included men at least 55 years of age and women at least 65 years of age with at least one additional clinical cardiovascular risk factor (or women at least 60 years of age with 2 additional risk factors). This report focuses on cognitive function in patients who were at least 70 years of age at the time of enrollment. Following a 4-week active treatment run-in period (you know by now that active run-ins can stack the deck in favor of the intervention), the researchers randomized patients to receive candesartan/hydrochlorothiazide 16/12.5 mg daily plus placebo (n = 593), rosuvastatin 10 mg daily plus placebo (n = 594), both active drugs (n = 587), or double placebo (n = 587). After the initial 6-week follow-up, the researchers assessed the patients every 6 months until the completion of HOPE-3 using 3 different standardized tools of cognitive function. Additionally, the researchers assessed the patients' functional status at baseline and at the end of the trial. At the end of the study, they had complete follow-up on only 69% of the enrolled patients, 9% of whom died. Among the remaining patients, after a median of 5.7 years of follow-up, the degree of change from baseline in any of the cognitive or functional measures was comparable in each of the 4 treatment groups. Candesartan/hydrochlorothiazide lowered blood pressure by 6 mm Hg more than placebo, and rosuvastatin lowered low-density lipoprotein cholesterol by 25 mg/dL more than placebo. Although some early case-control studies have suggested an association between statins and the development of dementia, neither cohort studies nor clinical trials, including this one, have found such an association.
Reviewer
Henry C. Barry, MD, MS
Professor
Michigan State University
East Lansing, MI
Comments
small sample
only <1700 pt in all. no indication of bp and cvs status prior to study randomization.
of the 69% reaching final followup its not clear which study arm lost which pt.Given small numbers these losses will affect the outcomes. Not clear about the 9% death number, in which study arm did these occur. Again the small numbers would be skewed by where these deaths occurred