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Am J Clin Nutr. 2017 Jul;106(1):35-43. doi: 10.3945/ajcn.117.153270. Epub 2017 May 17.

Low-fat dietary pattern and cardiovascular disease: results from the Women's Health Initiative randomized controlled trial.

Author information

Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA;
Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA.
Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL.
Health Promotion Sciences, Mel and Enid Zuckerman College of Public Health, University of Arizona, Tucson, AZ.
Department of Epidemiology, School of Public Health, University of Washington, Seattle, WA.
Department of Epidemiology, University of Iowa, Iowa City, IA.
Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.
Department of Family Medicine and Public Health, University of California, San Diego, La Jolla, CA.
National Heart, Lung, and Blood Institute, Bethesda, MD; and.
MedStar Health Research Institute and Georgetown/Howard Universities Center for Clinical and Translational Research, Washington, DC.


Background: The influence of a low-fat dietary pattern on the cardiovascular health of postmenopausal women continues to be of public health interest.Objective: This report evaluates low-fat dietary pattern influences on cardiovascular disease (CVD) incidence and mortality during the intervention and postintervention phases of the Women's Health Initiative Dietary Modification Trial.Design: Participants comprised 48,835 postmenopausal women aged 50-79 y; 40% were randomly assigned to a low-fat dietary pattern intervention (target of 20% of energy from fat), and 60% were randomly assigned to a usual diet comparison group. The 8.3-y intervention period ended in March 2005, after which >80% of surviving participants consented to additional active follow-up through September 2010; all participants were followed for mortality through 2013. Breast and colorectal cancer were the primary trial outcomes, and coronary heart disease (CHD) and overall CVD were additional designated outcomes.Results: Incidence rates for CHD and total CVD did not differ between the intervention and comparison groups in either the intervention or postintervention period. However, CHD HRs comparing these groups varied strongly with baseline CVD and hypertension status. Participants without prior CVD had an intervention period CHD HR of 0.70 (95% CI: 0.56, 0.87) or 1.04 (95% CI: 0.90, 1.19) if they were normotensive or hypertensive, respectively (P-interaction = 0.003). The CHD benefit among healthy normotensive women was partially offset by an increase in ischemic stroke risk. Corresponding HRs in the postintervention period were close to null. Participants with CVD at baseline (3.4%) had CHD HRs of 1.47 (95% CI: 1.12, 1.93) and 1.61 (95% CI: 1.02, 2.55) in the intervention and postintervention periods, respectively. However, various lines of evidence suggest that results in women with CVD or hypertension at baseline are confounded by postrandomization use of cholesterol-lowering medications.Conclusions: CVD risk in postmenopausal women appears to be sensitive to a change to a low-fat dietary pattern and, among healthy women, includes both CHD benefit and stroke risk. This trial was registered at as NCT00000611.


LDL cholesterol; cardiovascular disease; cholesterol-lowering medications; coronary heart disease; low-fat dietary pattern; nutritional behavioral intervention; postrandomization confounding; randomized controlled trial; stroke

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