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

Research output: Contribution to journalArticleResearchpeer-review

116 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.

Original languageEnglish
Pages (from-to)26.e1-26.e13
JournalAmerican Heart Journal
Volume155
Issue number1
DOIs
StatePublished - 1 Jan 2008

Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Cite this

@article{4a3a8344726f461e8fe3d5f80f655343,
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 J. Kim and Y. Bao and B. Chen and H. Chen and J. Chen and X. Chen and Y. Chen and Z. Chen and Z. Gao and X. Han and Z. Hu and J. Li and M. Li and X. Li and X. Li and X. Li and Y. Li and Y. Li and Y. Lin and F. Liu and J. Liu and L. Liu and Lu, {J. M.} and Peng, {Y. D.} and C. Wang and L. Wang and W. Wang and X. Wang and Wang, {Y. Z.} and Xue, {Y. M.} and Yang, {W. Y.} and L. Yuan and J. Zhang and X. Zhang and X. Zhang and L. Zhao and X. Zhou and Y. Zhou and I. Levin and J. Kim and J. Kim and J. Kim and Kim, {S. J.} and Kim, {Y. K.} and Woo, {J. T.} and M. Romanova and A. Vlad and I. Bondarenko and Egorova, {I. A.} and N. Gavrilova and Golubev, {A. V.} and Gurevich, {V. S.} and L. Ivanova and V. Kalashnikov and M. Kalashnikova and E. Kirillova and E. Nesterova and V. Orlov and V. Orlova and E. Solovieva and A. Volkova and I. Markova and V. Pavlova and C. Xie and P. Li and Y. Ma and M. Litvinenko and Y. Gao and X. Liu and Y. Ma and H. Wang and H. Wang and S. Wang and S. Wang and X. Wang and Y. Xu",
year = "2008",
month = "1",
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 = "Mosby Inc.",
number = "1",

}

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 journalArticleResearchpeer-review

TY - JOUR

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

T2 - The ORIGIN Trial (Outcome Reduction with an Initial Glargine Intervention)

AU - The ORIGIN Trial Investigators Hamilton, Ontario, Canada

AU - Kim, J.

AU - Bao, Y.

AU - Chen, B.

AU - Chen, H.

AU - Chen, J.

AU - Chen, X.

AU - Chen, Y.

AU - Chen, Z.

AU - Gao, Z.

AU - Han, X.

AU - Hu, Z.

AU - Li, J.

AU - Li, M.

AU - Li, X.

AU - Li, X.

AU - Li, X.

AU - Li, Y.

AU - Li, Y.

AU - Lin, Y.

AU - Liu, F.

AU - Liu, J.

AU - Liu, L.

AU - Lu, J. M.

AU - Peng, Y. D.

AU - Wang, C.

AU - Wang, L.

AU - Wang, W.

AU - Wang, X.

AU - Wang, Y. Z.

AU - Xue, Y. M.

AU - Yang, W. Y.

AU - Yuan, L.

AU - Zhang, J.

AU - Zhang, X.

AU - Zhang, X.

AU - Zhao, L.

AU - Zhou, X.

AU - Zhou, Y.

AU - Levin, I.

AU - Kim, J.

AU - Kim, J.

AU - Kim, J.

AU - Kim, S. J.

AU - Kim, Y. K.

AU - Woo, J. T.

AU - Romanova, M.

AU - Vlad, A.

AU - Bondarenko, I.

AU - Egorova, I. A.

AU - Gavrilova, N.

AU - Golubev, A. V.

AU - Gurevich, V. S.

AU - Ivanova, L.

AU - Kalashnikov, V.

AU - Kalashnikova, M.

AU - Kirillova, E.

AU - Nesterova, E.

AU - Orlov, V.

AU - Orlova, V.

AU - Solovieva, E.

AU - Volkova, A.

AU - Markova, I.

AU - Pavlova, V.

AU - Xie, C.

AU - Li, P.

AU - Ma, Y.

AU - Litvinenko, M.

AU - Gao, Y.

AU - Liu, X.

AU - Ma, Y.

AU - Wang, H.

AU - Wang, H.

AU - Wang, S.

AU - Wang, S.

AU - Wang, X.

AU - Xu, Y.

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 -