@article{09aa0d32450a419484b3b172109b4e71,
title = "Rationale, design, and baseline characteristics for a large international trial of cardiovascular disease prevention in people with dysglycemia: The ORIGIN Trial (Outcome Reduction with an Initial Glargine Intervention)",
abstract = "Aims Impaired fasting glucose (IFG), impaired glucose tolerance (IGT), and diabetes arise due to insufficient insulin secretion and are risk factors for cardiovascular (CV) events. Thus, targeting normal fasting glucose levels with insulin may reduce CV events. Previous studies suggest that ω-3 fatty acid supplements may reduce CV death; however, their effect in high-risk dysglycemic individuals is not known. Methods People aged ≥50 years with evidence of CV disease and with IFG, IGT, newly detected or established diabetes (on 0 or 1 oral agent), and a local glycated hemoglobin b150% of the upper limit of normal for that assay were recruited and allocated to (a) either 1 daily injection of insulin glargine with the dose titrated to achieve a fasting plasma glucose ω5.3 mmol/L (95 mg/dL), or standard glycemic care; and (b) either ω-3 Cacid ethyl esters 90 (1 g consisting of EPA 465 mg and DHA 375 mg) or identical placebo, according to a 2 × 2 factorial design. The 2 different primary outcomes for the insulin and ω-3 fatty acid arms are CV events and CV death, respectively. Results A total of 12612 (mean age 64, 35% women) people in 40 countries were randomized during a 2-year period ending December 2005. Eighty-two percent had established diabetes, 6% had new diabetes, and 12% had IGT or IFG; the mean fasting plasma glucose was 7.3 mmol/L (131 mg/dL). Conclusions The ORIGIN trial will determine whether or not either or both of these interventions can reduce CV events.",
author = "{The ORIGIN Trial Investigators Hamilton, Ontario, Canada} and Gerstein, {H. C.} and S. Yusuf and M. Riddle and L. Ryden and J. Bosch and S. Yusuf and L. Ryden and J. Bosch and L. Richardson and G. Dagenais and R. Diaz and P. Johnston and A. Maggioni and J. Probstfield and A. Ramachandran and M. Riddle and K. Birkeland and A. Budaj and E. Cardona and I. Chazova and P. Commerford and L. Danilova and R. Fernando and G. Fodor and J. Gamiz and R. Gilbert and R. Gomis and N. Hancu and M. Hanefeld and P. Hildebrandt and G. Kacerovsky-Bielesz and M. Keltai and J. Kim and H. Krum and H. Kultursay and F. Lanas and B. Lewis and E. Lonn and P. Lopez-Jaramillo and J. Marin-Neto and M. Marre and R. McKelvie and M. McQueen and I. Mendoza and C. Morillo and C. Pan and V. Pirags and V. Profozic and R. Ratner and J. Rosenstock and J. Rouleau and G. Spinas and S. Sreenan and I. Stoel and M. Syvanne and R. Vige and Yale, {J. F.} and R. Diaz and A. Accatoli and {Ahuad Guerrero}, {R. A.} and C. Alvarez and A. Alvarisqueta and M. Amuchastegui and M. Angos and V. Ankudowikz and P. Arias and H. Baglivo and R. Bagur and A. Baigorria and P. Baselga and F. Bello and B. Bertrand and J. Bono and S. Brito and {Bustamante Labarta}, M. and B. Bustos and R. Buzeki and Cabut, {A. M.} and A. Caccavo and H. Cantalupi and Canteros, {M. C.} and Capozzi, {M. N.} and M. Cardone and L. Cartasegna and A. Cassetari and P. Castano and R. Castellanos and Cerdan, {M. A.} and Cismondi, {M. T.} and A. Contreras and G. Coria and F. Corinaldesi and G. Costa and {Costa Vitali}, A. and C. Crespo and M. Cruz and Cuneo, {C. A.} and Cuello, {J. L.} and {De Loredo}, L. and {De Maria}, M. and R. Denaro and C. Devoto and C. Faingold and R. Falu and M. Farah and {Fares Taie}, A. and A. Fernandez and N. Ferrari and E. Forte and Y. Francisco and A. Gambarte and M. Garrido and F. Giachello and A. Gimenez and M. Gonzalez and Gonzalez, {M. A.} and V. Gorosito and Grosso, {K. A.} and N. Gutierrez and P. Guzman and L. Guzman and E. Hasbani and R. Henquin and A. Hershon and A. Hirschson and Hominal, {M. A.} and A. Hrabar and F. Krinsky and P. Kuschnir and {La Grutta}, M. and A. Liberman and Linari, {M. A.} and {Lobo Marquez}, L. and Lopez, {M. O.} and {Lopez Santi}, R. and J. Lowenstein and Luaces, {M. C.} and M. Luna and M. Luqueci and C. Luquez and I. Mackinnon and L. Mainini and C. Majul and N. Maldonado and R. Manzano and S. Manzur and L. Marani and E. Marco and G. Marcucci and D. Martinez and F. Martinez and Marzetti, {E. M.} and F. Massari and F. Meich and N. Migzilovsky and Molina, {M. P.} and O. Montana and S. Morales and H. Nanni and L. Nardone and Onofri, {L. V.} and Orlandini, {A. D.} and A. Oviedo and S. Pablo and Paez, {O. B.} and C. Pedernera and Pelagagge, {M. J.} and P. Perazzo and J. Plasentin and Plastino, {M. L.} and P. Polari and Pomposiello, {J. C.} and A. Prado and V. Prener and A. Ramirez and F. Reissig and G. Reyes and A. Rigourd and C. Rodriguez and M. Rodriguez and F. Rojas and A. Romeo and R. Ronderos and S. Saavedra and L. Sago and Sanchez, {J. M.} and Sanchez, {M. E.} and A. Sanchez and R. Sanchez and A. Sandrin and G. Saredo and J. Secchi and Sernia, {V. L.} and I. Sinay and {Sosa Liprandi}, A. and L. Soso and G. Sposetti and P. Streitenberger and G. Suarez and H. Tonin and F. Triguero and Ulla, {M. R.} and J. Valdez and Verdinelli, {C. A.} and Vico, {M. L.} and C. Videla and A. Villamil and E. Viola and {Viscaya Castro}, A. and V. Visco and D. Vogel and F. Waisman and J. Zaidman and J. Zilberman and R. Gilbert and H. Krum and R. Allan and C. Allen and J. Amerena and L. Arnolda and D. Ashby and S. Baker and M. Binnekamp and I. Bruce and R. Burnet and B. Champion and C. Chang and Chen, {K. K.L.} and S. Clarke and S. Colagiuri and P. Colman and D. Colquhoun and S. Davis and D. Day and M. D'Emden and H. Eaton and {El Kassi}, S. and M. Erickson and A. Farshid and G. Gordon and M. Guhu and J. Harmer and V. Heazlewood and R. Hendriks and J. Ho and V. Jayadev and I. Jeffery and B. Yeap",
year = "2008",
month = jan,
day = "1",
doi = "10.1016/j.ahj.2007.09.009",
language = "English",
volume = "155",
pages = "26.e1--26.e13",
journal = "American Heart Journal",
issn = "0002-8703",
publisher = "Elsevier - Mosby",
number = "1",
}