N-3 fatty acids and cardiovascular outcomes in patients with dysglycemia

ORIGIN Trial Investigators

Research output: Contribution to journalArticle

497 Citations (Scopus)

Abstract

Background: The use of n-3 fatty acids may prevent cardiovascular events in patients with recent myocardial infarction or heart failure. Their effects in patients with (or at risk for) type 2 diabetes mellitus are unknown. Methods: In this double-blind study with a 2-by-2 factorial design, we randomly assigned 12,536 patients who were at high risk for cardiovascular events and had impaired fasting glucose, impaired glucose tolerance, or diabetes to receive a 1-g capsule containing at least 900 mg (90% or more) of ethyl esters of n-3 fatty acids or placebo daily and to receive either insulin glargine or standard care. The primary outcome was death from cardiovascular causes. The results of the comparison between n-3 fatty acids and placebo are reported here. Results: During a median follow up of 6.2 years, the incidence of the primary outcome was not significantly decreased among patients receiving n-3 fatty acids, as compared with those receiving placebo (574 patients [9.1%] vs. 581 patients [9.3%]; hazard ratio, 0.98; 95% confidence interval [CI], 0.87 to 1.10; P = 0.72). The use of n-3 fatty acids also had no significant effect on the rates of major vascular events (1034 patients [16.5%] vs. 1017 patients [16.3%]; hazard ratio, 1.01; 95% CI, 0.93 to 1.10; P = 0.81), death from any cause (951 [15.1%] vs. 964 [15.4%]; hazard ratio, 0.98; 95% CI, 0.89 to 1.07; P = 0.63), or death from arrhythmia (288 [4.6%] vs. 259 [4.1%]; hazard ratio, 1.10; 95% CI, 0.93 to 1.30; P = 0.26). Triglyceride levels were reduced by 14.5 mg per deciliter (0.16 mmol per liter) more among patients receiving n-3 fatty acids than among those receiving placebo (P<0.001), without a significant effect on other lipids. Adverse effects were similar in the two groups. Conclusions: Daily supplementation with 1 g of n-3 fatty acids did not reduce the rate of cardiovascular events in patients at high risk for cardiovascular events. (Funded by Sanofi; ORIGIN ClinicalTrials.gov number, NCT00069784.).

Original languageEnglish (US)
Pages (from-to)309-318
Number of pages10
JournalNew England Journal of Medicine
Volume367
Issue number4
DOIs
StatePublished - Jul 26 2012
Externally publishedYes

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Omega-3 Fatty Acids
Placebos
Confidence Intervals
Cause of Death
Heart Failure
Glucose Intolerance
Double-Blind Method
Type 2 Diabetes Mellitus
Capsules
Blood Vessels
Cardiac Arrhythmias
Fasting
Esters
Triglycerides
Myocardial Infarction
Lipids
Glucose
Incidence

ASJC Scopus subject areas

  • Medicine(all)

Cite this

N-3 fatty acids and cardiovascular outcomes in patients with dysglycemia. / ORIGIN Trial Investigators.

In: New England Journal of Medicine, Vol. 367, No. 4, 26.07.2012, p. 309-318.

Research output: Contribution to journalArticle

ORIGIN Trial Investigators. / N-3 fatty acids and cardiovascular outcomes in patients with dysglycemia. In: New England Journal of Medicine. 2012 ; Vol. 367, No. 4. pp. 309-318.
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abstract = "Background: The use of n-3 fatty acids may prevent cardiovascular events in patients with recent myocardial infarction or heart failure. Their effects in patients with (or at risk for) type 2 diabetes mellitus are unknown. Methods: In this double-blind study with a 2-by-2 factorial design, we randomly assigned 12,536 patients who were at high risk for cardiovascular events and had impaired fasting glucose, impaired glucose tolerance, or diabetes to receive a 1-g capsule containing at least 900 mg (90{\%} or more) of ethyl esters of n-3 fatty acids or placebo daily and to receive either insulin glargine or standard care. The primary outcome was death from cardiovascular causes. The results of the comparison between n-3 fatty acids and placebo are reported here. Results: During a median follow up of 6.2 years, the incidence of the primary outcome was not significantly decreased among patients receiving n-3 fatty acids, as compared with those receiving placebo (574 patients [9.1{\%}] vs. 581 patients [9.3{\%}]; hazard ratio, 0.98; 95{\%} confidence interval [CI], 0.87 to 1.10; P = 0.72). The use of n-3 fatty acids also had no significant effect on the rates of major vascular events (1034 patients [16.5{\%}] vs. 1017 patients [16.3{\%}]; hazard ratio, 1.01; 95{\%} CI, 0.93 to 1.10; P = 0.81), death from any cause (951 [15.1{\%}] vs. 964 [15.4{\%}]; hazard ratio, 0.98; 95{\%} CI, 0.89 to 1.07; P = 0.63), or death from arrhythmia (288 [4.6{\%}] vs. 259 [4.1{\%}]; hazard ratio, 1.10; 95{\%} CI, 0.93 to 1.30; P = 0.26). Triglyceride levels were reduced by 14.5 mg per deciliter (0.16 mmol per liter) more among patients receiving n-3 fatty acids than among those receiving placebo (P<0.001), without a significant effect on other lipids. Adverse effects were similar in the two groups. Conclusions: Daily supplementation with 1 g of n-3 fatty acids did not reduce the rate of cardiovascular events in patients at high risk for cardiovascular events. (Funded by Sanofi; ORIGIN ClinicalTrials.gov number, NCT00069784.).",
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T1 - N-3 fatty acids and cardiovascular outcomes in patients with dysglycemia

AU - ORIGIN Trial Investigators

AU - Bosch, Jackie

AU - Gerstein, Hertzel C.

AU - Dagenais, Gilles R.

AU - Díaz, Rafael

AU - Dyal, Leanne

AU - Jung, Hyejung

AU - Maggiono, Aldo P.

AU - Probstfield, Jeffrey

AU - Ramachandran, Ambady

AU - Riddle, Matthew C.

AU - Rydén, Lars E.

AU - Yusuf, Salim

AU - Richardson, L.

AU - Diaz, R.

AU - Johnston, P.

AU - Vige, R.

AU - Birkeland, K.

AU - Budaj, A.

AU - Cardona, E.

AU - Chazova, I.

AU - Commerford, P.

AU - Danilova, L.

AU - Davies, M.

AU - Fernando, R.

AU - Fodor, G.

AU - Gilbert, R.

AU - Gomis, R.

AU - Hâncu, N.

AU - Hanefeld, M.

AU - Hildebrandt, P.

AU - Kacerovsky-Bielesz, G.

AU - Keltai, M.

AU - Kim, J. H.

AU - Krum, H.

AU - Kültürsay, H.

AU - Lanas, F.

AU - Lewis, B. S.

AU - Lonn, E.

AU - López-Jaramillo, P.

AU - Marin-Neto, J.

AU - Marre, M.

AU - McKelvie, R.

AU - McQueen, M.

AU - Mendoza, I.

AU - Morillo, C.

AU - Pan, C.

AU - Pīrāgs, V.

AU - Profozic, V.

AU - Ratner, R.

AU - Ahmann, Andrew

PY - 2012/7/26

Y1 - 2012/7/26

N2 - Background: The use of n-3 fatty acids may prevent cardiovascular events in patients with recent myocardial infarction or heart failure. Their effects in patients with (or at risk for) type 2 diabetes mellitus are unknown. Methods: In this double-blind study with a 2-by-2 factorial design, we randomly assigned 12,536 patients who were at high risk for cardiovascular events and had impaired fasting glucose, impaired glucose tolerance, or diabetes to receive a 1-g capsule containing at least 900 mg (90% or more) of ethyl esters of n-3 fatty acids or placebo daily and to receive either insulin glargine or standard care. The primary outcome was death from cardiovascular causes. The results of the comparison between n-3 fatty acids and placebo are reported here. Results: During a median follow up of 6.2 years, the incidence of the primary outcome was not significantly decreased among patients receiving n-3 fatty acids, as compared with those receiving placebo (574 patients [9.1%] vs. 581 patients [9.3%]; hazard ratio, 0.98; 95% confidence interval [CI], 0.87 to 1.10; P = 0.72). The use of n-3 fatty acids also had no significant effect on the rates of major vascular events (1034 patients [16.5%] vs. 1017 patients [16.3%]; hazard ratio, 1.01; 95% CI, 0.93 to 1.10; P = 0.81), death from any cause (951 [15.1%] vs. 964 [15.4%]; hazard ratio, 0.98; 95% CI, 0.89 to 1.07; P = 0.63), or death from arrhythmia (288 [4.6%] vs. 259 [4.1%]; hazard ratio, 1.10; 95% CI, 0.93 to 1.30; P = 0.26). Triglyceride levels were reduced by 14.5 mg per deciliter (0.16 mmol per liter) more among patients receiving n-3 fatty acids than among those receiving placebo (P<0.001), without a significant effect on other lipids. Adverse effects were similar in the two groups. Conclusions: Daily supplementation with 1 g of n-3 fatty acids did not reduce the rate of cardiovascular events in patients at high risk for cardiovascular events. (Funded by Sanofi; ORIGIN ClinicalTrials.gov number, NCT00069784.).

AB - Background: The use of n-3 fatty acids may prevent cardiovascular events in patients with recent myocardial infarction or heart failure. Their effects in patients with (or at risk for) type 2 diabetes mellitus are unknown. Methods: In this double-blind study with a 2-by-2 factorial design, we randomly assigned 12,536 patients who were at high risk for cardiovascular events and had impaired fasting glucose, impaired glucose tolerance, or diabetes to receive a 1-g capsule containing at least 900 mg (90% or more) of ethyl esters of n-3 fatty acids or placebo daily and to receive either insulin glargine or standard care. The primary outcome was death from cardiovascular causes. The results of the comparison between n-3 fatty acids and placebo are reported here. Results: During a median follow up of 6.2 years, the incidence of the primary outcome was not significantly decreased among patients receiving n-3 fatty acids, as compared with those receiving placebo (574 patients [9.1%] vs. 581 patients [9.3%]; hazard ratio, 0.98; 95% confidence interval [CI], 0.87 to 1.10; P = 0.72). The use of n-3 fatty acids also had no significant effect on the rates of major vascular events (1034 patients [16.5%] vs. 1017 patients [16.3%]; hazard ratio, 1.01; 95% CI, 0.93 to 1.10; P = 0.81), death from any cause (951 [15.1%] vs. 964 [15.4%]; hazard ratio, 0.98; 95% CI, 0.89 to 1.07; P = 0.63), or death from arrhythmia (288 [4.6%] vs. 259 [4.1%]; hazard ratio, 1.10; 95% CI, 0.93 to 1.30; P = 0.26). Triglyceride levels were reduced by 14.5 mg per deciliter (0.16 mmol per liter) more among patients receiving n-3 fatty acids than among those receiving placebo (P<0.001), without a significant effect on other lipids. Adverse effects were similar in the two groups. Conclusions: Daily supplementation with 1 g of n-3 fatty acids did not reduce the rate of cardiovascular events in patients at high risk for cardiovascular events. (Funded by Sanofi; ORIGIN ClinicalTrials.gov number, NCT00069784.).

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