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)

The ORIGIN Trial Investigators Hamilton, Ontario, Canada, H. C. Gerstein, S. Yusuf, M. Riddle, L. Ryden, J. Bosch, L. Richardson, G. Dagenais, R. Diaz, P. Johnston, A. Maggioni, J. Probstfield, A. Ramachandran, K. Birkeland, A. Budaj, E. Cardona, I. Chazova, P. Commerford, L. Danilova, M. Davies & 31 others R. Fernando, G. Fodor, J. Gamiz, R. Gilbert, R. Gomis, N. Hancu, M. Hanefeld, P. Hildebrandt, G. Kacerovsky-Bielesz, M. Keltai, J. Kim, H. Krum, H. Kultursay, F. Lanas, B. Lewis, E. Lonn, P. Lopez-Jaramillo, J. Marin-Neto, M. Marre, R. McKelvie, M. McQueen, I. Mendoza, C. Morillo, C. Pan, V. Pirags, V. Profozic, R. Ratner, J. Rosenstock, J. Rouleau, G. Spinas, Anne Taylor

Research output: Contribution to journalArticle

117 Citations (Scopus)

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.

LanguageEnglish
Pages26.e1-26.e13
JournalAmerican Heart Journal
Volume155
Issue number1
DOIs
Publication statusPublished - 1 Jan 2008

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

@article{1ee87688f04b4a20a5a9502e1504c7f3,
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 L. Richardson and G. Dagenais and R. Diaz and P. Johnston and A. Maggioni and J. Probstfield and A. Ramachandran and K. Birkeland and A. Budaj and E. Cardona and I. Chazova and P. Commerford and L. Danilova and M. Davies 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 Anne Taylor",
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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). / The ORIGIN Trial Investigators Hamilton, Ontario, Canada.

In: American Heart Journal, Vol. 155, No. 1, 01.01.2008, p. 26.e1-26.e13.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Rationale, design, and baseline characteristics for a large international trial of cardiovascular disease prevention in people with dysglycemia

T2 - American Heart Journal

AU - The ORIGIN Trial Investigators Hamilton, Ontario, Canada

AU - Gerstein, H. C.

AU - Yusuf, S.

AU - Riddle, M.

AU - Ryden, L.

AU - Bosch, J.

AU - Richardson, L.

AU - Dagenais, G.

AU - Diaz, R.

AU - Johnston, P.

AU - Maggioni, A.

AU - Probstfield, J.

AU - Ramachandran, A.

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 - Gamiz, J.

AU - Gilbert, R.

AU - Gomis, R.

AU - Hancu, N.

AU - Hanefeld, M.

AU - Hildebrandt, P.

AU - Kacerovsky-Bielesz, G.

AU - Keltai, M.

AU - Kim, J.

AU - Krum, H.

AU - Kultursay, H.

AU - Lanas, F.

AU - Lewis, B.

AU - Lonn, E.

AU - Lopez-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 - Pirags, V.

AU - Profozic, V.

AU - Ratner, R.

AU - Rosenstock, J.

AU - Rouleau, J.

AU - Spinas, G.

AU - Taylor, Anne

PY - 2008/1/1

Y1 - 2008/1/1

N2 - 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.

AB - 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.

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U2 - 10.1016/j.ahj.2007.09.009

DO - 10.1016/j.ahj.2007.09.009

M3 - Article

VL - 155

SP - 26.e1-26.e13

JO - American Heart Journal

JF - American Heart Journal

SN - 0002-8703

IS - 1

ER -