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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)
- Publication Year :
- 2008
-
Abstract
- ims: 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.
- Subjects :
- Blood Glucose
Male
medicine.medical_specialty
International Cooperation
medicine.medical_treatment
MACE diabetes glargin
Insulin Glargine
Severity of Illness Index
Drug Administration Schedule
Impaired glucose tolerance
chemistry.chemical_compound
Reference Values
Internal medicine
Diabetes mellitus
medicine
Humans
Hypoglycemic Agents
Insulin
Aged
Probability
Proportional Hazards Models
Glycemic
Glycated Hemoglobin
Glucose tolerance test
Dose-Response Relationship, Drug
medicine.diagnostic_test
Insulin glargine
business.industry
Patient Selection
Glucose Tolerance Test
Middle Aged
Impaired fasting glucose
medicine.disease
Survival Analysis
origin, glargine
Insulin, Long-Acting
Treatment Outcome
Endocrinology
Diabetes Mellitus, Type 2
chemistry
Cardiovascular Diseases
Research Design
Female
Glycated hemoglobin
Cardiology and Cardiovascular Medicine
business
Follow-Up Studies
medicine.drug
Subjects
Details
- Language :
- English
- Database :
- OpenAIRE
- Accession number :
- edsair.doi.dedup.....06d272c50be25e2996cba24e06ae64e7