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

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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). / ORIGIN Trial Investigators.

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

Research output: Contribution to journal › Article › peer-review

BibTeX

@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 = "{ORIGIN Trial Investigators} 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 = 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 = "Mosby Inc.",

number = "1",

}

RIS

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 - ORIGIN Trial Investigators

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, 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 - Zhao, L.

AU - Zhou, X.

AU - Zhou, Y.

AU - Levin, I.

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, 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.

UR - http://www.scopus.com/inward/record.url?scp=36749121985&partnerID=8YFLogxK

U2 - 10.1016/j.ahj.2007.09.009

DO - 10.1016/j.ahj.2007.09.009

M3 - Article

AN - SCOPUS:36749121985

VL - 155

SP - 26.e1-26.e13

JO - American Heart Journal

JF - American Heart Journal

SN - 0002-8703

IS - 1

ER -

ID: 38740101

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)

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