TY - JOUR
T1 - Cardiovascular and other outcomes postintervention with insulin glargine and omega-3 fatty acids (ORIGINALE)
AU - ORIGIN Trial
AU - Punthakee, Zubin
AU - Mendoza, I.
A2 - Gerstein, H. C.
A2 - Bosch, J.
A2 - Dagenais, G. R.
A2 - Díaz, R.
A2 - Jung, H.
A2 - Maggioni, A. P.
A2 - Pogue, J.
A2 - Probstfield, J.
A2 - Ramachandran, A.
A2 - Riddle, M. C.
A2 - Rydén, L. E.
A2 - Yusuf, S.
A2 - Richardson, L.
A2 - Diaz, R.
A2 - Johnston, P.
A2 - Vige, R.
A2 - Birkeland, K.
A2 - Cardona, E.
A2 - Danilova, L.
A2 - Davies, M.
A2 - Fernando, R.
A2 - Gilbert, R.
A2 - Hanefeld, M.
A2 - Hildebrandt, P.
A2 - Keltai, M.
A2 - Lonn, E.
A2 - Marre, M.
A2 - Morillo, C.
A2 - Pirags, V.
A2 - Lejnieks, A.
A2 - Markova, I.
N1 - Publisher Copyright:
© 2016 by the American Diabetes Association.
PY - 2016/5/1
Y1 - 2016/5/1
N2 - 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 to insulin glargine (2,351) versus standard care (2,367), and 4,771 originally allocatedto 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.
AB - 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 to insulin glargine (2,351) versus standard care (2,367), and 4,771 originally allocatedto 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.
UR - http://www.scopus.com/inward/record.url?scp=84964754284&partnerID=8YFLogxK
U2 - 10.2337/dc15-1676
DO - 10.2337/dc15-1676
M3 - Article
C2 - 26681720
AN - SCOPUS:84964754284
SN - 0149-5992
VL - 39
SP - 709
EP - 716
JO - Diabetes Care
JF - Diabetes Care
IS - 5
ER -
