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

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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 journal › Article › peer-review

BibTeX

@article{83cf908087d94eb6a8e9aa46444dbe15,

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

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 Kim, {J. H.} and V. Pavlova and R. Kumar and Y. Bao and B. Chen and H. Chen and J. Chen and L. Chen and M. Chen and Y. Chen and P. Feng and C. Gao and F. Gao and X. Gao and Z. Gao and Y. Gong and X. Guo and X. Han and M. Li and Q. Li and X. Li and Y. Li and F. Liu and Z. Liu and B. Lu and J. Lu and Y. Peng and Y. Ren and Y. Shao and Y. Shi and H. Sun and L. Sun and X. Sun and C. Wang and F. Wang and L. Wang and Q. Wang and W. Wang and X. Wang and Y. Wang and J. Wen and H. Wu and J. Wu and M. Wu and Y. Xue and H. Yang and W. Yang and Z. Yang and L. Yao and H. Yu and X. Yu and L. Yuan and M. Yuan and W. Yuan and Y. Yuan and J. Zhang and R. Zhang and X. Zhang and L. Zhao and W. Zhou and Y. Zhu and J. Zou and I. Levin and Y. Cho and Y. Choi and D. Kim and I. Kim and Kim, {J. H.} and S. Kim and H. Kwon and J. Lee and S. Oh and J. Woo and M. Romanova and A. Vlad and A. Babenko and I. Bondarenko and I. Egorova and N. Gavrilova and A. Golubev and V. Gurevich and L. Ivanova and M. Kalashnikova and E. Kirillova and K. Krylov and E. Nesterova and V. Orlov and V. Orlova and A. Shubina and S. Shustov and A. Volkova and N. Zhukova and I. Markova and A. Ali and D. Donovan and M. Litvinenko and Y. Lin and Q. Liu and Z. Tan and M. Tang and J. Zhao and Kim, {J. H.} and Y. Kim and Y. Song and E. Timoshina and S. Chan and Y. Du and Y. He and C. Huang and H. Li and S. Liu and X. Luo and Y. Ma and H. Wang and S. Wang and Y. Xie and X. Xu and Y. Xu and M. Zhou and A. Meier and L. Li and J. You and K. Mitchell",

note = "Publisher Copyright: {\textcopyright} 2016 by the American Diabetes Association.",

year = "2016",

month = may,

day = "1",

doi = "10.2337/dc15-1676",

language = "English",

volume = "39",

pages = "709--716",

journal = "Diabetes Care",

issn = "1935-5548",

publisher = "American Diabetes Association Inc.",

number = "5",

}

RIS

TY - JOUR

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

AU - ORIGIN Trial Investigators

AU - Kim, J. H.

AU - Pavlova, V.

AU - Kumar, R.

AU - Bao, Y.

AU - Chen, B.

AU - Chen, H.

AU - Chen, J.

AU - Chen, L.

AU - Chen, M.

AU - Chen, Y.

AU - Feng, P.

AU - Gao, C.

AU - Gao, F.

AU - Gao, X.

AU - Gao, Z.

AU - Gong, Y.

AU - Guo, X.

AU - Han, X.

AU - Li, M.

AU - Li, Q.

AU - Li, X.

AU - Li, Y.

AU - Liu, F.

AU - Liu, Z.

AU - Lu, B.

AU - Lu, J.

AU - Peng, Y.

AU - Ren, Y.

AU - Shao, Y.

AU - Shi, Y.

AU - Sun, H.

AU - Sun, L.

AU - Sun, X.

AU - Wang, C.

AU - Wang, F.

AU - Wang, L.

AU - Wang, Q.

AU - Wang, W.

AU - Wang, X.

AU - Wang, Y.

AU - Wen, J.

AU - Wu, H.

AU - Wu, J.

AU - Wu, M.

AU - Xue, Y.

AU - Yang, H.

AU - Yang, W.

AU - Yang, Z.

AU - Yao, L.

AU - Yu, H.

AU - Yu, X.

AU - Yuan, L.

AU - Yuan, M.

AU - Yuan, W.

AU - Yuan, Y.

AU - Zhang, J.

AU - Zhang, R.

AU - Zhang, X.

AU - Zhao, L.

AU - Zhou, W.

AU - Zhu, Y.

AU - Zou, J.

AU - Levin, I.

AU - Cho, Y.

AU - Choi, Y.

AU - Kim, D.

AU - Kim, I.

AU - Kim, J. H.

AU - Kim, S.

AU - Kwon, H.

AU - Lee, J.

AU - Oh, S.

AU - Woo, J.

AU - Romanova, M.

AU - Vlad, A.

AU - Babenko, A.

AU - Bondarenko, I.

AU - Egorova, I.

AU - Gavrilova, N.

AU - Golubev, A.

AU - Gurevich, V.

AU - Ivanova, L.

AU - Kalashnikova, M.

AU - Kirillova, E.

AU - Krylov, K.

AU - Nesterova, E.

AU - Orlov, V.

AU - Orlova, V.

AU - Shubina, A.

AU - Shustov, S.

AU - Volkova, A.

AU - Zhukova, N.

AU - Markova, I.

AU - Ali, A.

AU - Donovan, D.

AU - Litvinenko, M.

AU - Lin, Y.

AU - Liu, Q.

AU - Tan, Z.

AU - Tang, M.

AU - Zhao, J.

AU - Kim, J. H.

AU - Kim, Y.

AU - Song, Y.

AU - Timoshina, E.

AU - Chan, S.

AU - Du, Y.

AU - He, Y.

AU - Huang, C.

AU - Li, H.

AU - Liu, S.

AU - Luo, X.

AU - Ma, Y.

AU - Wang, H.

AU - Wang, S.

AU - Xie, Y.

AU - Xu, X.

AU - Xu, Y.

AU - Zhou, M.

AU - Meier, A.

AU - Li, L.

AU - You, J.

AU - Mitchell, K.

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

VL - 39

SP - 709

EP - 716

JO - Diabetes Care

JF - Diabetes Care

SN - 1935-5548

IS - 5

ER -

ID: 90685981