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Working Group on Future Clinical Research Directions on Omega-3 Fatty Acids and Cardiovascular DiseaseBethesda Marriott Hotel, Pooks HillJune 2, 2004Full Report of the Working GroupSummary of MeetingA Working Group meeting was held on June 2, 2004 chaired by Dr. Scott Grundy. The main objective of this working group was to review evidence-based reports on the effects of omega-3 fatty acids on CVD and CVD risk factors, recently released by the Agency of Healthcare Quality and Research, and to advise the NHLBI and Office of Dietary Supplements on future directions for research to fill gaps in knowledge on these issues. The working group concluded that the body of evidence supports the hypothesis that ingestion of omega-3 fatty acids reduces CVD risk but that a definitive trial is needed. The evidence comes from cohort studies conducted in a variety of population samples, including U.S. samples, that consisted mostly of individuals without CVD. There have been few clinical trials conducted, which were generally in men who had experienced a heart attack, and mostly conducted in Europe and elsewhere, where background diets and medical care differ from the U.S. Much of the trial evidence is based on one large trial that had an open-label control group rather than a placebo control group. The benefit does not appear to function through effects on CVD risk factors, but seems to work through an independent mechanism, probably on arrhythmias and sudden cardiac death. The body of evidence is highly suggestive but not definitive that omega-3 fatty acids reduce CVD. The working group recommended that a randomized clinical trial be conducted to test the effects of omega-3 fatty acids on CVD events. They recommended the trial be conducted in a high-risk population comprised of both high-risk primary prevention as well as secondary prevention participants using a design testing two dietary supplements (fish-based EPA and DHA as well as plant-based alpha- linolenic acid, the latter because of its high public health applicability) and a placebo control group. They recommended that ancillary studies should be encouraged to evaluate mechanisms by which omega-3 fatty acids may reduce CVD and to examine dose-response relationships. A report of the working group meeting is currently under preparation. Participants ListScott Grundy, M.D., Ph.D. (Chair) Professor The University of Texas Southwestern Medical Center at Dallas Center for Human Nutrition Dallas, TX Christine M. Albert, M.D., M.P.H. Assistant Professor of Medicine Division of Preventive Medicine Harvard Medical School Brigham and Women's Hospital Boston, Massachusetts Lawrence J. Appel, M.D., M.P.H. Professor of Medicine, Epidemiology, and International Health (Human Nutrition) Johns Hopkins Medical Institutions Baltimore, Maryland Ethan Balk, M.D. Tufts-New England Medical Center Boston, Massachusetts Michael A. Blazing, M.D. Assistant Professor of Medicine Cardiology Associates Duke University Medical Center Durham, North Carolina Marianne Geleijnse, Ph.D. Wageningen University Division of Human Nutrition THE NETHERLANDS Abhinav Goyal, M.D. Cardiology Fellow Department for Medicine and Cardiology Duke University Medical Center Durham, North Carolina Eliseo Guallar, M.D. Assistant Professor and Core Faculty Member Welch Center for Prevention, Epidemiology, and Clinical Research Johns Hopkins Medical Institutions Baltimore, Maryland William S. Harris, Ph.D. Co-Director, Lipid and Diabetes Research Center Mid America Heart Institute of St. Luke's Hospital System Kansas City, Missouri Terry A. Jacobson, M.D. Associate Professor of Medicine Director, Office of Health Promotion and Disease Prevention Emory University School of Medicine Atlanta, Georgia Penny M. Kris-Etherton, Ph.D. Distinguished Professor of Nutrition Department of Nutritional Sciences The Pennsylvania State University University Park, Pennsylvania Frank M. Sacks, M.D. Professor Department of Nutrition Harvard School of Public Health Boston, Massachusetts David Siscovick, M.D., M.P.H. Professor of Medicine and Epidemiology Co-Director, Cardiovascular Health Research Unit University of Washington Seattle, Washington NIH Staff National Heart, Lung, and Blood Institute Jeffrey A. Cutler, M.D. Senior Scientific Advisor Division of Epidemiology and Clinical Applications National Heart, Lung, and Blood Institute National Institutes of Health Bethesda, Maryland Paula T. Einhorn, M.D. Medical Officer Division of Epidemiology and Clinical Applications National Heart, Lung, and Blood Institute National Institutes of Health Bethesda, Maryland Nancy L. Geller, Ph.D. Director, Office of Biostatistics Research National Heart, Lung, and Blood Institute National Institutes of Health Bethesda, Maryland David A. Lathrop, Ph.D. Leader, Ischemia, Arrhythmia, and Sudden Cardiac Death Scientific Research Group Division of Heart and Vascular Disease National Heart, Lung, and Blood Institute National Institutes of Health Bethesda, Maryland Catherine (Cay) M. Loria, Ph.D., M.S., M.A. Epidemiologist Division of Epidemiology and Clinical Applications National Heart, Lung, and Blood Institute National Institutes of Health Bethesda, Maryland Eva Obarzanek, Ph.D., M.P.H., R.D. Acting Leader, Prevention Scientific Research Group Division of Epidemiology and Clinical Applications National Heart, Lung, and Blood Institute National Institutes of Health Bethesda, Maryland Charlotte A. Pratt, Ph.D. Research Nutritionist Division of Epidemiology and Clinical Applications National Heart, Lung, and Blood Institute National Institutes of Health Bethesda, Maryland Yves Rosenberg, M.D. Medical Officer Division of Epidemiology and Clinical Applications National Heart, Lung, and Blood Institute National Institutes of Health Bethesda, Maryland Denise G. Simons-Morton, M.D., Ph.D. Director, Clinical Applications and Prevention Program Division of Epidemiology and Clinical Applications National Heart, Lung, and Blood Institute National Institutes of Health Bethesda, Maryland Office of Dietary Supplements Paul M. Coates, Ph.D. Director, Office of Dietary Supplements National Institutes of Health Bethesda, Maryland Anne Thurn, Ph.D. Director, Evidence-Based Review Program Office of Dietary Supplements National Institutes of Health Bethesda, Maryland |