Effect of Intensive vs Standard Blood Pressure Control on Probable Dementia

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Abstract

There are currently no proven treatments to reduce the risk of mild cognitive impairment and dementia.

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Most cited references 16

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The design and rationale of a multicenter clinical trial comparing two strategies for control of systolic blood pressure: the Systolic Blood Pressure Intervention Trial (SPRINT).

Peter Wright, Paul K. Whelton, Jackie K. Cheung … (2014)

High blood pressure is an important public health concern because it is highly prevalent and a risk factor for adverse health outcomes, including coronary heart disease, stroke, decompensated heart failure, chronic kidney disease, and decline in cognitive function. Observational studies show a progressive increase in risk associated with blood pressure above 115/75 mm Hg. Prior research has shown that reducing elevated systolic blood pressure lowers the risk of subsequent clinical complications from cardiovascular disease. However, the optimal systolic blood pressure to reduce blood pressure-related adverse outcomes is unclear, and the benefit of treating to a level of systolic blood pressure well below 140 mm Hg has not been proven in a large, definitive clinical trial. To describe the design considerations of the Systolic Blood Pressure Intervention Trial (SPRINT) and the baseline characteristics of trial participants. The Systolic Blood Pressure Intervention Trial is a multicenter, randomized, controlled trial that compares two strategies for treating systolic blood pressure: one targets the standard target of <140 mm Hg, and the other targets a more intensive target of <120 mm Hg. Enrollment focused on volunteers of age ≥50 years (no upper limit) with an average baseline systolic blood pressure ≥130 mm Hg and evidence of cardiovascular disease, chronic kidney disease, 10-year Framingham cardiovascular disease risk score ≥15%, or age ≥75 years. The Systolic Blood Pressure Intervention Trial recruitment also targeted three pre-specified subgroups: participants with chronic kidney disease (estimated glomerular filtration rate <60 mL/min/1.73 m(2)), participants with a history of cardiovascular disease, and participants 75 years of age or older. The primary outcome is first the occurrence of a myocardial infarction (MI), acute coronary syndrome, stroke, heart failure, or cardiovascular disease death. Secondary outcomes include all-cause mortality, decline in kidney function or development of end-stage renal disease, incident dementia, decline in cognitive function, and small-vessel cerebral ischemic disease. Between 8 November 2010 and 15 March 2013, Systolic Blood Pressure Intervention Trial recruited and randomized 9361 people at 102 clinics, including 3331 women, 2648 with chronic kidney disease, 1877 with a history of cardiovascular disease, 3962 minorities, and 2636 ≥75 years of age. Although the overall recruitment target was met, the numbers recruited in the high-risk subgroups were lower than planned. The Systolic Blood Pressure Intervention Trial will provide important information on the risks and benefits of intensive blood pressure treatment targets in a diverse sample of high-risk participants, including those with prior cardiovascular disease, chronic kidney disease, and those aged ≥75 years. © The Author(s) 2014.

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Incident dementia and blood pressure lowering in the Hypertension in the Very Elderly Trial cognitive function assessment (HYVET-COG): a double-blind, placebo controlled trial.

S. Ma, , Richard Walton … (2008)

Observational epidemiological studies have shown a positive association between hypertension and risk of incident dementia; however, the effects of antihypertensive therapy on cognitive function in controlled trials have been conflicting, and meta-analyses of the trials have not provided clear evidence of whether antihypertensive treatment reduces dementia incidence. The Hypertension in the Very Elderly trial (HYVET) was designed to assess the risks and benefits of treatment of hypertension in elderly patients and included an assessment of cognitive function. Patients with hypertension (systolic pressure 160-200 mm Hg; diastolic pressure <110 mm Hg) who were aged 80 years or older were enrolled in this double-blind, placebo-controlled trial. Participants were randomly assigned to receive 1.5 mg slow release indapamide, with the option of 2-4 mg perindopril, or placebo. The target systolic blood pressure was 150 mm Hg; the target diastolic blood pressure was 80 mm Hg. Participants had no clinical diagnosis of dementia at baseline, and cognitive function was assessed at baseline and annually with the mini-mental state examination (MMSE). Possible cases of incident dementia (a fall in the MMSE score to <24 points or a drop of three points in 1 year) were assessed by standard diagnostic criteria and expert review. The trial was stopped in 2007 at the second interim analysis after treatment resulted in a reduction in stroke and total mortality. Analysis was by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT00122811. 3336 HYVET participants had at least one follow-up assessment (mean 2.2 years) and were included: 1687 participants were randomly assigned to the treatment group and 1649 to the placebo group. Only five reports of adverse effects were attributed to the medication: three in the placebo group and two in the treatment group. The mean decrease in systolic blood pressure between the treatment and placebo groups at 2 years was systolic -15 mm Hg, p<0.0001; and diastolic -5.9 mm Hg, p<0.0001. There were 263 incident cases of dementia. The rates of incident dementia were 38 per 1000 patient-years in the placebo group and 33 per 1000 patient-years in the treatment group. There was no significant difference between treatment and placebo groups (hazard ratio [HR] 0.86, 95% CI 0.67-1.09); however, when these data were combined in a meta-analysis with other placebo-controlled trials of antihypertensive treatment, the combined risk ratio favoured treatment (HR 0.87, 0.76-1.00, p=0.045). Antihypertensive treatment in elderly patients does not statistically reduce incidence of dementia. This negative finding might have been due to the short follow-up, owing to the early termination of the trial, or the modest effect of treatment. Nevertheless, the HYVET findings, when included in a meta-analysis, might support antihypertensive treatment to reduce incident dementia.

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Midlife vascular risk factors and late-life mild cognitive impairment: A population-based study.

M Kivipelto, E.-L. Helkala, T Hänninen … (2001)

To evaluate the impact of midlife elevated serum cholesterol levels and blood pressure on the subsequent development of mild cognitive impairment (MCI) and to investigate the prevalence of MCI in elderly Finnish population, applying the MCI criteria devised by the Mayo Clinic Alzheimer's Disease Research Center. MCI has been considered as a predictor of AD. Vascular risk factors may be important in the development of cognitive impairment and AD. However, the role of vascular risk factors in MCI and the prevalence of MCI still remain virtually unknown. Subjects were derived from random, population-based samples previously studied in surveys carried out in 1972, 1977, 1982, and 1987. After an average follow-up of 21 years, 1,449 subjects aged 65 to 79 years were reexamined in 1998. Eighty-two subjects, 6.1% of the population (average age, 72 years) met the criteria for MCI. Midlife elevated serum cholesterol level (> or =6.5 mmol/L) was a significant risk factor for MCI (OR, 1.9; 95% CI, 1.2 to 3.0, adjusted for age and body mass index); the effect of systolic blood pressure approached significance. Data point to a role for midlife vascular risk factors in the development of MCI in late life.

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Author and article information

Journal

Title: JAMA

Abbreviated Title: JAMA

Publisher: American Medical Association (AMA)

ISSN (Print): 0098-7484

Publication date (Electronic): January 28 2019

Affiliations

[1 ]Section of Gerontology and Geriatric Medicine, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina

[2 ]Department of Biostatistics and Data Science, Wake Forest School of Medicine, Winston-Salem, North Carolina

[3 ]Department of Neurology, University of Mississippi Medical Center, Jackson

[4 ]Department of Radiology, University of Pennsylvania, Philadelphia

[5 ]Department of Neurology, University of Utah School of Medicine, Salt Lake City

[6 ]Division of Nephrology and Hypertension, University of Utah School of Medicine, Salt Lake City

[7 ]Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Winston-Salem, North Carolina

[8 ]Department of Psychology, University of Alabama at Birmingham

[9 ]Preventive Medicine Section, Veterans Affairs Medical Center, Memphis, Tennessee

[10 ]Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute, Bethesda, Maryland

[11 ]Clinical Applications and Prevention Branch, National Heart, Lung, and Blood Institute, Bethesda, Maryland

[12 ]Department of Preventive Medicine, University of Tennessee Health Science Center, Memphis

[13 ]Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Disorders, Bethesda, Maryland

[14 ]Division of Nephrology, Stanford University School of Medicine; Palo Alto, California

[15 ]Neuroepidemiology Section, Intramural Research Program, National Institute on Aging, Bethesda, Maryland

[16 ]Department of Neurology, Case Western Reserve University School of Medicine, Cleveland, Ohio

[17 ]Department of Epidemiology, University of Alabama at Birmingham

[18 ]National Institute of Neurological Disorders and Stroke, Bethesda, Maryland

[19 ]Department of Medicine, University of Alabama at Birmingham

[20 ]Department of Medicine, Louis Stokes Cleveland Veterans Affairs Medical Center, Case Western Reserve University, Cleveland, Ohio

[21 ]Department of Psychiatry and Behavioral Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina

[22 ]Section of Nephrology, Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina

[23 ]Department of Neurology, Wake Forest School of Medicine, Winston-Salem, North Carolina

[24 ]Frances Payne Bolton School of Nursing, Case Western Reserve University, Cleveland, Ohio

[25 ]Division of Geriatrics, University of Utah School of Medicine, Salt Lake City

[26 ]Division of Nephrology, Tufts Medical Center, Boston, Massachusetts

[27 ]Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana

[28 ]Division of Nephrology and Hypertension, Department of Medicine, Case Western Reserve University, Cleveland, Ohio

Article

DOI: 10.1001/jama.2018.21442

PMC ID: 6439590

PubMed ID: 30688979

SO-VID: 2022e8b3-45df-493f-a8cb-34ffa82299df

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Effect of Intensive vs Standard Blood Pressure Control on Probable Dementia : A Randomized Clinical Trial

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Most cited references 16

The design and rationale of a multicenter clinical trial comparing two strategies for control of systolic blood pressure: the Systolic Blood Pressure Intervention Trial (SPRINT).

Incident dementia and blood pressure lowering in the Hypertension in the Very Elderly Trial cognitive function assessment (HYVET-COG): a double-blind, placebo controlled trial.

Midlife vascular risk factors and late-life mild cognitive impairment: A population-based study.

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