Cardiovascular and other outcomes postintervention with insulin glargine and omega-3 fatty acids (ORIGINALE)

ORIGIN Trial Investigators

Research output: Contribution to journalArticle

29 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)709-716
Number of pages8
JournalDiabetes care
Volume39
Issue number5
DOIs
StatePublished - May 1 2016

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Omega-3 Fatty Acids
Myocardial Infarction
neutral insulin
Random Allocation
Placebos
Insulin Glargine
Neoplasms
Hospitalization
Research Design
Heart Failure
Observation
Health
Therapeutics

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism
  • Advanced and Specialized Nursing

Cite this

Cardiovascular and other outcomes postintervention with insulin glargine and omega-3 fatty acids (ORIGINALE). / ORIGIN Trial Investigators.

In: Diabetes care, Vol. 39, No. 5, 01.05.2016, p. 709-716.

Research output: Contribution to journalArticle

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abstract = "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.",
author = "{ORIGIN Trial Investigators} and Gerstein, {H. C.} and J. Bosch and Dagenais, {G. R.} and R. D{\'i}az and H. Jung and Maggioni, {A. P.} and J. Pogue and J. Probstfield and A. Ramachandran and Riddle, {M. C.} and Ryd{\'e}n, {L. E.} and S. Yusuf and L. Richardson and R. Diaz and P. Johnston and R. Vige and K. Birkeland and A. Budaj and E. Cardona and I. Chazova and P. Commerford and L. Danilova and M. Davies and R. Fernando and G. Fodor and R. Gilbert and R. Gomis and N. H{\^a}ncu and M. Hanefeld and P. Hildebrandt and G. Kacerovsky-Bielesz and M. Keltai and Kim, {J. H.} and H. Krum and H. K{\"u}lt{\"u}rsay and F. Lanas and Lewis, {B. S.} and E. Lonn and P. L{\'o}pez-Jaramillo and J. Marin-Neto and M. Marre and R. McKelvie and M. McQueen and I. Mendoza and C. Morillo and C. Pan and V. Pīrāgs and {de Lemos}, {James A} and McGuire, {Darren K} and Meneghini, {Luigi F}",
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TY - JOUR

T1 - Cardiovascular and other outcomes postintervention with insulin glargine and omega-3 fatty acids (ORIGINALE)

AU - ORIGIN Trial Investigators

AU - Gerstein, H. C.

AU - Bosch, J.

AU - Dagenais, G. R.

AU - Díaz, R.

AU - Jung, H.

AU - Maggioni, A. P.

AU - Pogue, J.

AU - Probstfield, J.

AU - Ramachandran, A.

AU - Riddle, M. C.

AU - Rydén, L. E.

AU - Yusuf, S.

AU - Richardson, L.

AU - Diaz, R.

AU - Johnston, P.

AU - Vige, R.

AU - Birkeland, K.

AU - Budaj, A.

AU - Cardona, E.

AU - Chazova, I.

AU - Commerford, P.

AU - Danilova, L.

AU - Davies, M.

AU - Fernando, R.

AU - Fodor, G.

AU - Gilbert, R.

AU - Gomis, R.

AU - Hâncu, N.

AU - Hanefeld, M.

AU - Hildebrandt, P.

AU - Kacerovsky-Bielesz, G.

AU - Keltai, M.

AU - Kim, J. H.

AU - Krum, H.

AU - Kültürsay, H.

AU - Lanas, F.

AU - Lewis, B. S.

AU - Lonn, E.

AU - López-Jaramillo, P.

AU - Marin-Neto, J.

AU - Marre, M.

AU - McKelvie, R.

AU - McQueen, M.

AU - Mendoza, I.

AU - Morillo, C.

AU - Pan, C.

AU - Pīrāgs, V.

AU - de Lemos, James A

AU - McGuire, Darren K

AU - Meneghini, Luigi F

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.

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