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Cardiovascular and Other Outcomes Postintervention With Insulin Glargine and Omega-3 Fatty Acids (ORIGINALE).
- Source :
-
Diabetes Care . May2016, Vol. 39 Issue 5, p709-716. 8p. 5 Charts. - Publication Year :
- 2016
-
Abstract
- <bold>Objective: </bold>The Outcome Reduction With Initial Glargine Intervention (ORIGIN) trial reported neutral effects of insulin glargine on cardiovascular outcomes and cancers and reduced incident diabetes in high-cardiovascular risk adults with dysglycemia after 6.2 years of active treatment. Omega-3 fatty acids had neutral effects on cardiovascular outcomes. The ORIGIN and Legacy Effects (ORIGINALE) study measured posttrial effects of these interventions during an additional 2.7 years.<bold>Research Design and Methods: </bold>Surviving ORIGIN participants attended up to two additional visits. The hazard of clinical outcomes during the entire follow-up period from randomization was calculated.<bold>Results: </bold>Of 12,537 participants randomized, posttrial data were analyzed for 4,718 originally allocated to insulin glargine (2,351) versus standard care (2,367), and 4,771 originally allocated to omega-3 fatty acid supplements (2,368) versus placebo (2,403). Posttrial, small differences in median HbA1c persisted (glargine 6.6% [49 mmol/mol], standard care 6.7% [50 mmol/mol], P = 0.025). From randomization to the end of posttrial follow-up, no differences were found between the glargine and standard care groups in myocardial infarction, stroke, or cardiovascular death (1,185 vs. 1,165 events; hazard ratio 1.01 [95% CI 0.94-1.10]; P = 0.72); myocardial infarction, stroke, cardiovascular death, revascularization, or hospitalization for heart failure (1,958 vs. 1,910 events; 1.03 [0.97-1.10]; P = 0.38); or any cancer (524 vs. 529 events; 0.99 [0.88-1.12]; P = 0.91) or between omega-3 and placebo groups in cardiovascular death (688 vs. 700; 0.98 [0.88-1.09]; P = 0.68) or other outcomes.<bold>Conclusions: </bold>During >6 years of treatment followed by >2.5 years of observation, insulin glargine had neutral effects on health outcomes and salutary effects on metabolic control, whereas omega-3 fatty acid supplementation had no effect. [ABSTRACT FROM AUTHOR]
- Subjects :
- *OMEGA-3 fatty acids
*INSULIN
*DIABETIC cardiomyopathy
*CANCER
*PLACEBOS
*CARDIOVASCULAR disease prevention
*TYPE 2 diabetes complications
*CARDIOVASCULAR diseases
*COMPARATIVE studies
*DIETARY supplements
*GLYCOSYLATED hemoglobin
*HYPOGLYCEMIC agents
*LONGITUDINAL method
*RESEARCH methodology
*MEDICAL cooperation
*TYPE 2 diabetes
*RESEARCH
*EVALUATION research
*RANDOMIZED controlled trials
*TREATMENT effectiveness
*SULFONYLUREAS
*METFORMIN
*PROPORTIONAL hazards models
*DISEASE complications
Subjects
Details
- Language :
- English
- ISSN :
- 01495992
- Volume :
- 39
- Issue :
- 5
- Database :
- Academic Search Index
- Journal :
- Diabetes Care
- Publication Type :
- Academic Journal
- Accession number :
- 114742978
- Full Text :
- https://doi.org/10.2337/dc15-1676