TY - JOUR
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 - Rosenstock, J.
AU - Spinas, G. A.
AU - Sreenan, S.
AU - Stoel, I.
AU - Syvänne, M.
AU - Yale, J. F.
AU - Avezum, A.
AU - Bahit, M. C.
AU - Bogaty, P.
AU - Bordeleau, L.
AU - Chacόn, C.
AU - Corson, M.
AU - Harper, W. L.
AU - Halon, D.
AU - Magloire, P.
AU - Mann, J.
AU - Pavlova, V.
AU - Punthakee, Z.
AU - Silva, J.
AU - Tsang, B.
AU - Yakubovich, N.
AU - Abdallah, A.
AU - Ahmad, S.
AU - Chandra, J.
AU - Chandra, R.
AU - Cukierman-Yaffee, T.
AU - Joldersma, L.
AU - MacRae, L.
AU - MacRae, S.
AU - Malik, S.
AU - Mead, A.
AU - Pasha, F.
AU - Pazmino-Canizares, J.
AU - Pohl, K.
AU - Sakalas, A.
AU - Tyrwhitt, J.
AU - Ahuad Guerrero, R.
AU - Alebuena, A.
AU - Alvarez, N.
AU - Alzogaray, M.
AU - Amuchastegui, M.
AU - Andres, M.
AU - Angos, M.
AU - Baglivo, H.
AU - Barbieri, M.
AU - Bassi, F.
AU - Bello, F.
AU - Bono, J.
AU - Bustamante Labarta, M.
AU - Bustos, B.
AU - Caccavo, A.
AU - Calveira, M.
AU - Camino, A.
AU - Cantero, M.
AU - Capozzi, M.
AU - Cardone, M.
AU - Cartasegna, L.
AU - Cassetari, A.
AU - Castellanos, R.
AU - Chavez Caballero, R.
AU - Cipullo, M.
AU - Contreras, A.
AU - Coria, J.
AU - Corinaldesi, F.
AU - Costa, G.
AU - Crespo, C.
AU - Cruz, M.
AU - Cuello, J.
AU - Cuneo, C.
AU - Del Corro, I.
AU - Diez, R.
AU - Dituro, C.
AU - Dominguez, A.
AU - Facta, A.
AU - Faingold, C.
AU - Farah, M.
AU - Fares Taie, A.
AU - Fernandez, A.
AU - Ferrari, A.
AU - Ferrari, N.
AU - Garcia Monteverde, C.
AU - Garrido, M.
AU - Giachello, C.
AU - Gonzalez, M.
AU - Gutierrez, N.
AU - Guzman, L.
AU - Guzman, P.
AU - Hasbani, E.
AU - Henquin, R.
AU - Hershon, A.
AU - Hirschon Alvarez Prado, A.
AU - Hominal, M.
AU - Hrabar, A.
AU - Imposti, H.
AU - La Grutta, M.
AU - Lanchiotti, P.
AU - Lobo Marquez, L.
AU - Lopez Santi, R.
AU - Lowenstein, J.
AU - Lugo, M.
AU - Luqueci, M.
AU - Mainini, S.
AU - Majul, C.
AU - Manzano, R.
AU - Manzur, S.
AU - Marcucci, G.
AU - Marino, M.
AU - Massari, F.
AU - Mendez, N.
AU - Molina, M.
AU - Montaña, O.
AU - Mulazzi, M.
AU - Nardone, L.
AU - Odetto, I.
AU - Orlandini, A.
AU - Oviedo, A.
AU - Paez, O.
AU - Parnas, A.
AU - Patron, F. R.
AU - Pedernera, C.
AU - Pelagagge, M.
AU - Plastino, M.
AU - Polari, P.
AU - Pomposiello, J.
AU - Porta, A.
AU - Prado, A.
AU - Quiroz, M.
AU - Ramirez, A.
AU - Rodriguez, C.
AU - Rodriguez, M.
AU - Ronderos, R.
AU - Sago, L.
AU - Sanchez, A.
AU - Sanchez, R.
AU - Sandrin, A.
AU - Schygiel, P.
AU - Sernia, V.
AU - Sinay, I.
AU - Smith Casabella, T.
AU - Sosa Liprandi, A.
AU - Sosa Liprandi, M.
AU - Soso, L.
AU - Sposetti, G.
AU - Stisman, D.
AU - Streitenberger, P.
AU - Suarez, G.
AU - Tonin, H.
AU - Ulla, M.
AU - Valdez, J.
AU - Vico, M.
AU - Villamil, A.
AU - Villarino, A.
AU - Viscaya Castro, A.
AU - Visco, V.
AU - Vogel, D.
AU - Waisman, F.
AU - Zaidman, C.
AU - Amerena, J.
AU - Applebe, A.
AU - Aylward, P.
AU - Binnekamp, M.
AU - Bruce, I.
AU - Burdeniuk, C.
AU - Burnet, R.
AU - Colman, P.
AU - Colquhoun, D.
AU - Davis, S.
AU - De Looze, F.
AU - De Pasquale, C.
AU - D'Emden, M.
AU - Eaton, H.
AU - Farshid, A.
AU - Foulanos, S.
AU - Galanos, J.
AU - Gordon, G.
AU - Guhu, M.
AU - Ho, J.
AU - Jeffery, I.
AU - Jerums, G.
AU - Kwan, M.
AU - Lefkovits, J.
AU - Luu, S.
AU - MacIsaac, R.
AU - Marjason, J.
AU - Mohabbati, V.
AU - Nankervis, A.
AU - O'Neal, D.
AU - Perera, N.
AU - Poynten, A.
AU - Rahman, A.
AU - Razak, S.
AU - Roberts, T.
AU - Sebastian, M.
AU - Simpson, R.
AU - Soldatos, G.
AU - Sullivan, D.
AU - Teede, H.
AU - Tiong, F.
AU - Topliss, D.
AU - Torpy, D.
AU - Shah, P.
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 -