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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).
Am Heart J 2008; 155(1):26-32, 32.e1-6AH

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 omega-3 fatty acid supplements may reduce CV death; however, their effect in high-risk dysglycemic individuals is not known.

METHODS

People aged > or = 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 < 150% 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 < or = 5.3 mmol/L (95 mg/dL), or standard glycemic care; and (b) either omega-3-acid ethyl esters 90 (1 g consisting of EPA 465 mg and DHA 375 mg) or identical placebo, according to a 2 x 2 factorial design. The 2 different primary outcomes for the insulin and omega-3 fatty acid arms are CV events and CV death, respectively.

RESULTS

A total of 12,612 (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.

Authors

No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

18082485

Citation

Origin Trial Investigators, et al. "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)." American Heart Journal, vol. 155, no. 1, 2008, pp. 26-32, 32.e1-6.
Origin Trial Investigators, Gerstein H, Yusuf S, et al. 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). Am Heart J. 2008;155(1):26-32, 32.e1-6.
Gerstein, H., Yusuf, S., Riddle, M. C., Ryden, L., & Bosch, J. (2008). 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). American Heart Journal, 155(1), pp. 26-32, 32.e1-6.
Origin Trial Investigators, et al. 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). Am Heart J. 2008;155(1):26-32, 32.e1-6. PubMed PMID: 18082485.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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). AU - ,, AU - Gerstein,Hertzel, AU - Yusuf,Salim, AU - Riddle,Matthew C, AU - Ryden,Lars, AU - Bosch,Jackie, Y1 - 2007/11/26/ PY - 2007/07/04/received PY - 2007/09/21/accepted PY - 2007/12/18/pubmed PY - 2008/1/11/medline PY - 2007/12/18/entrez SP - 26-32, 32.e1-6 JF - American heart journal JO - Am. Heart J. VL - 155 IS - 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 omega-3 fatty acid supplements may reduce CV death; however, their effect in high-risk dysglycemic individuals is not known. METHODS: People aged > or = 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 < 150% 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 < or = 5.3 mmol/L (95 mg/dL), or standard glycemic care; and (b) either omega-3-acid ethyl esters 90 (1 g consisting of EPA 465 mg and DHA 375 mg) or identical placebo, according to a 2 x 2 factorial design. The 2 different primary outcomes for the insulin and omega-3 fatty acid arms are CV events and CV death, respectively. RESULTS: A total of 12,612 (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. SN - 1097-6744 UR - https://www.unboundmedicine.com/medline/citation/18082485/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__ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0002-8703(07)00772-7 DB - PRIME DP - Unbound Medicine ER -