TY - JOUR
T1 - N-3 fatty acids and cardiovascular outcomes in patients with dysglycemia
AU - ORIGIN Trial
A2 - Bosch, Jackie
A2 - Gerstein, Hertzel C.
A2 - Dagenais, Gilles R.
A2 - Díaz, Rafael
A2 - Dyal, Leanne
A2 - Jung, Hyejung
A2 - Maggiono, Aldo P.
A2 - Probstfield, Jeffrey
A2 - Ramachandran, Ambady
A2 - Riddle, Matthew C.
A2 - Rydén, Lars E.
A2 - Yusuf, Salim
A2 - Richardson, L.
A2 - Diaz, R.
A2 - Johnston, P.
A2 - Vige, R.
A2 - Birkeland, K.
A2 - Budaj, A.
A2 - Cardona, E.
A2 - Chazova, I.
A2 - Commerford, P.
A2 - Danilova, L.
A2 - Davies, M.
A2 - Fernando, R.
A2 - Fodor, G.
A2 - Gilbert, R.
A2 - Gomis, R.
A2 - Hâncu, N.
A2 - Hanefeld, M.
A2 - Hildebrandt, P.
A2 - Kacerovsky-Bielesz, G.
A2 - Keltai, M.
A2 - Kim, J. H.
A2 - Krum, H.
A2 - Kültürsay, H.
A2 - Lanas, F.
A2 - Lewis, B. S.
A2 - Lonn, E.
A2 - López-Jaramillo, P.
A2 - Marin-Neto, J.
A2 - Marre, M.
A2 - McKelvie, R.
A2 - McQueen, M.
A2 - Mendoza, I.
A2 - Morillo, C.
A2 - Pan, C.
A2 - Pirags, V.
A2 - Lejnieks, A.
A2 - Markova, I.
N1 - Publisher Copyright:
Copyright © 2012 Massachusetts Medical Society.
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.).
UR - http://www.scopus.com/inward/record.url?scp=84864219466&partnerID=8YFLogxK
U2 - 10.1056/NEJMoa1203859
DO - 10.1056/NEJMoa1203859
M3 - Article
C2 - 22686415
AN - SCOPUS:84864219466
SN - 0028-4793
VL - 367
SP - 309
EP - 318
JO - New England Journal of Medicine
JF - New England Journal of Medicine
IS - 4
ER -
