魚油は糖尿病患者における心血管イベントを予防しない(Abstract 2317)
オメガ3サプリメントは糖尿病患者の心筋梗塞（MI）または脳卒中を予防しない、とのASCENDトライアルのレイトブレイキング結果がESC Congress 2018 で発表され、New England Journal of Medicine に掲載された。ASCENDトライアルの平均追跡期間7.4年間に、初回の重篤な血管イベントはオメガ3サプリメント群の689人（8.9%）およびプラセボ群の712人（9.2%）において発現し、2群間に有意差がないことが示された（p=0.55）。糖尿病患者において心血管イベント予防目的で魚油を推奨する根拠はない、と筆者らは結論付けている。
Omega 3 supplements do not prevent myocardial infarction (MI) or strokes in patients with diabetes, according to late breaking results from the ASCEND trial presented in a Hot Line Session at ESC Congress 2018 and published in the New England Journal of Medicine.
In observational studies, higher consumption of fish is associated with lower risks of coronary artery disease and stroke. However, previous randomized trials have not been able to show that taking fish oil supplements containing omega-3 fatty acids reduce the risk of having cardiovascular events.
The ASCEND trial (A Study of Cardiovascular Events iN Diabetes) examined whether fish oil supplements reduce the risk of a cardiovascular event in patients with diabetes. Between 2005 and 2011, 15,480 patients with diabetes but no history of cardiovascular disease were randomly assigned to fish oil supplementation (1 g daily) or matching placebo.
The primary efficacy outcome was first serious vascular event, which included non-fatal MIs, non-fatal strokes or transient ischemic attacks or deaths from a cardiovascular cause (but excluding any intracranial hemorrhage).
During an average of 7.4 years of follow-up, a first serious vascular event occurred in 689 (8.9%) participants allocated Omega 3 supplements and 712 (9.2%) participants allocated placebo. There was no significant difference between the two groups: rate ratio of 0.97 (95% confidence interval 0.87–1.08, p=0.55).
Dr. Louise Bowman, principal investigator, Nuffield Department of Population Health, University of Oxford, UK, said: "Our large, long-term randomized trial shows that Omega 3 supplements do not reduce the risk of cardiovascular events in patients with diabetes. This is a disappointing finding, but it is in line with previous randomized trials in other types of patient at increased risk of cardiovascular events which also showed no benefit of fish oil supplements. There is no justification for recommending fish oil supplements to protect against cardiovascular events."
SOURCES OF FUNDING: British Heart Foundation, Medical Research Council Population Health Research Unit (MRC-PHRU), Abbott, Bayer AG, Mylan, Solvay.
DISCLOSURES: The study was designed and run independently of the funders by the Clinical Trial Service Unit & Epidemiological Studies Unit (CTSU) in the Nuffield Department of Population Health (NDPH). The lead investigators abide by the CTSU guidelines not to accept payment or honoraria from drug companies.
