OBJECTIVE: 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. RESEARCH DESIGN AND METHODS: Surviving ORIGIN participants attended up to two additional visits. The hazard of clinical outcomes during the entire follow-up period from randomization was calculated. RESULTS: Of 12,537 participants randomized, posttrial data were analyzed for 4,718 originally allocated toinsulin 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. CONCLUSIONS: 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.
RCT Entities:
OBJECTIVE: The Outcome Reduction With Initial Glargine Intervention (ORIGIN) trial reported neutral effects of insulinglargine 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. RESEARCH DESIGN AND METHODS: Surviving ORIGIN participants attended up to two additional visits. The hazard of clinical outcomes during the entire follow-up period from randomization was calculated. RESULTS: Of 12,537 participants randomized, posttrial data were analyzed for 4,718 originally allocated to insulinglargine (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. CONCLUSIONS: During >6 years of treatment followed by >2.5 years of observation, insulinglargine had neutral effects on health outcomes and salutary effects on metabolic control, whereas omega-3 fatty acid supplementation had no effect.
Authors: Katsiaryna Bykov; Mengdong He; Jessica M Franklin; Elizabeth M Garry; John D Seeger; Elisabetta Patorno Journal: Diabetes Obes Metab Date: 2019-05-29 Impact factor: 6.577
Authors: Asmaa S Abdelhamid; Tracey J Brown; Julii S Brainard; Priti Biswas; Gabrielle C Thorpe; Helen J Moore; Katherine Ho Deane; Fai K AlAbdulghafoor; Carolyn D Summerbell; Helen V Worthington; Fujian Song; Lee Hooper Journal: Cochrane Database Syst Rev Date: 2018-11-30
Authors: Asmaa S Abdelhamid; Nicole Martin; Charlene Bridges; Julii S Brainard; Xia Wang; Tracey J Brown; Sarah Hanson; Oluseyi F Jimoh; Sarah M Ajabnoor; Katherine Ho Deane; Fujian Song; Lee Hooper Journal: Cochrane Database Syst Rev Date: 2018-11-27
Authors: Asmaa S Abdelhamid; Tracey J Brown; Julii S Brainard; Priti Biswas; Gabrielle C Thorpe; Helen J Moore; Katherine Ho Deane; Fai K AlAbdulghafoor; Carolyn D Summerbell; Helen V Worthington; Fujian Song; Lee Hooper Journal: Cochrane Database Syst Rev Date: 2018-07-18
Authors: Asmaa S Abdelhamid; Nicole Martin; Charlene Bridges; Julii S Brainard; Xia Wang; Tracey J Brown; Sarah Hanson; Oluseyi F Jimoh; Sarah M Ajabnoor; Katherine Ho Deane; Fujian Song; Lee Hooper Journal: Cochrane Database Syst Rev Date: 2018-07-18