Issledovanie ORIGIN (Outcome Reduction with Initial Glargine INtervention) 2 goda spustya: chto novogo?


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Abstract

The article considers outcomes of the ORIGIN study, the main results of which were first presented in 2012. The main purpose of this study was to evaluate the effects of therapy with insulin glargine (IG) compared with standard glucose-lowering therapy (in combination with ω-3 polyunsaturated fatty acids or placebo) in relation to the reducing the risk of cardiovascular diseases (CVD) and / or mortality in patients with prediabetes or «early» type 2 diabetes mellitus (DM) and high cardiovascular risk. Subsequently, ORIGIN study was expanded through several additional studies and a subanalyses, the results of which are discussed in this review. It has been shown that treatment with IG provides a stable, long-term glycemic control, with neutral impact on the cardiovascular outcomes, relatively low risk of hypoglycemia and small weight gain. Achievement of the fasting normoglycemia as a result of therapy with IG allows to reduce the risk of microvascular complications. Compared with standard therapy, severe hypoglycemia during therapy with the IG is less associated with the cardiovascular outcomes. Therapy with IG slows the progression of atherosclerosis, but has no effect on the progression of cognitive dysfunction. The presence of long-term effects of the therapy applied in the ORIGIN study will be known after the analysis of the results of ORIGINALE study (follow-up over participants of the ORIGIN study).

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I. V Glinkina

References

  1. The ORIGIN Trial Investigators. Basal insulin and cardiovascular and other outcomes in dysglycemia. N. Engl. J. Med. 2012; 367(4): 319-28.
  2. The ORIGIN Trial Investigators. n-3 Fatty acids and cardiovascular outcomes in patients with dysglycemia. N. Engl. J. Med. 2012; 367(4): 309-18.
  3. The ORIGIN Trial Investigators. Supplementary appendix for: Basal insulin and cardiovascular and other outcomes in dysglycemia. N. Engl. J. Med. 2012; 367(4): 319-328 (onlineappendix).
  4. The ORIGIN Trial Investigators. Basal insulin glargine and microvascular outcomes in dysglycaemic individuals: results of the Outcome Reduction with an Initial Glargine Intervention (ORIGIN) trial Diabetologia.
  5. The ORIGIN Trial Investigators. Does hypoglycaemia increase the risk of cardiovascular events? A report from the ORIGIN trial. Eur. Heart J. doi: 10.1093/eurheartj/eht332
  6. Lonn E.M., Bosch J., Diaz R., et al. Effect of insulin glargine and n-3FA on carotid intima-media thickness in people with dysglycemia at high risk for cardiovascular events: the Glucose Reduction and Atherosclerosis Continuing Evaluation Study (ORIGIN-GRACE). Diabetes Care. 2013; Early access.
  7. The ORIGIN Trial Investigators. Effects of basal insulin glargine and omega-3 fatty acid on cognitive decline and probable cognitive impairment in people with dysglycaemia: a substudy of the ORIGIN trial. www.thelancet.com/diabetes-endo-crinology Published online June 2, 2014. http: //dx.doi.org/10.1016/S2213-8587(14)70062-2
  8. Gerstein H., Yusuf S., Punthakee Z. The ORIGINALE Study (ORIGIN and Legacy Effects). Available at: http://origintrial.org
  9. Stratton I.M., Adler A.I., Neil H.A., et al. Association of glycaemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. BMJ. 2000; 321: 405-12.
  10. Diabetes Control and Complications Trial Research Group. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N. Engl. J. Med. 1993; 329: 977-86.
  11. UK Prospective Diabetes Study (UKPDS) Group. Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Lancet. 1998; 352: 837-53.
  12. Patel A., MacMahon S., Chalmers J., et al. Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes. N. Engl. J. Med. 2008; 358: 2560-72.
  13. Desouza C., Salazar H., Cheong B., Murgo J., Fonseca V. Associationofhypoglycemia and cardiac ischemia: a study based on continuous monitoring. Diabetes Care. 2003; 26: 1485-89.
  14. Heller S.R. Cardiac arrhythmias in hypoglycaemia. Diabetes Nutr. Metab. 2002; 15: 461-65.
  15. Frier B.M., Schernthaner G., Heller S.R. Hypoglycemia and cardiovascular risks. Diabetes Care. 2011; 34: S132-37.
  16. Yakubovich N., Gerstein H.C. Serious cardiovascular outcomes in diabetes: the role of hypoglycemia. Circulation. 2011; 123: 342-48.
  17. Zoungas S., Patel A., Chalmers J., et al. Severe hypoglycemia and risks of vascular events and death. N. Engl. J. Med. 2010; 363: 1410-18.
  18. Duckworth W., Abraira C., Moritz T., et al. Glucose control and vascular complications in veterans with type 2 diabetes. N. Engl. J. Med. 2009; 360: 129-29.
  19. Genuth S., Ismail-Beigi F., Grimm R.H. Jr, et al. Effects of intensive glucose lowering in type 2 diabetes. N. Engl. J. Med. 2008; 358: 2545-59.
  20. Patel A., MacMahon S., Chalmers J., et al. Intensive blood glucose control and vascular outcomes in patients with type 2 diabetes. N. Engl. J. Med. 2008; 358: 2560-72.
  21. Mellbin L.G., Malmberg K., Waldenstrom A., Wedel H., Ryden L. Prognostic implications of hypoglycaemic episodes during hospitalisation for myocardial infarction in patients with type 2 diabetes: a report from the DIGAMI 2 trial. Heart. 2009; 95: 721-27.
  22. Riveline J.P., Danchin N., Ledru F., et al. Sulfonylureas and cardiovascular effects: from experimental data to clinical use. Available data in humans and clinical applications. Diabetes Metab. 2003; 29: 207-222.
  23. Vehkavaara S., Yki-Jarvinen H. 3.5 years of insulin therapy with insulin glargine improves in vivo endothelial function in type 2 diabetes. Arterioscler. Thromb. Vasc. Biol. 2004; 24: 325-30.
  24. Taskinen M.R., Kuusi T., Helve E., et al. Insulin therapy induces antiatherogenic changes of serum lipoproteins in noninsulin-dependent diabetes. Arteriosclerosis. 1988; 8: 168-77.
  25. Nathan D.M., Cleary P.A., Backlund J.Y., et al.; Diabetes Control and Complications Trial / Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Study Research Group. Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes. N. Engl. J. Med. 2005; 353: 2643-53.
  26. Bornfeldt K.E., Tabas I. Insulin resistance, hyperglycemia, and atherosclerosis. Cell Metab. 2011; 14: 575-85.
  27. Muntoni S., Muntoni S., Draznin B. Effects of chronic hyperinsulinemia in insulin-resistant patients. Curr. Diab. Rep. 2008; 8: 233-38.
  28. Nandish S., Bailon O., Wyatt J., et al. Vasculotoxic effects of insulin and its role in atherosclerosis: what is the evidence? Curr. Atheroscler. Rep. 2011; 13: 123-28.
  29. Nathan D.M., Cleary P.A., Backlund J.Y., et al. Diabetes Control and Complications Trial/ Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) Study Research Group. Intensive diabetes treatment and cardiovascular disease in patients with type 1 diabetes. N. Engl. J. Med. 2005; 353: 2643-53.
  30. Holman R.R., Paul S.K., Bethel M.A., et al. 10-year follow-up of intensive glucose control in type 2 diabetes. N. Engl. J. Med. 2008; 359: 1577-80.
  31. Boussageon R., Bejan-Angoulvant T., Saadatian-Elahi M., et al. Effect of intensive glucose lowering treatment on all cause mortality, cardiovascular death, and microvascular events in type 2 diabetes: metaanalysis of randomised controlled trials. BMJ. 2011; 343: d4169.
  32. U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER). Guidance for Industry: Diabetes Mellitus - Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes [Internet], December 2008. Available from www.fda.gov/down-loads/
  33. Sydenham E., Dangour A.D., Lim W.S. Omega-3-fatty acid for the prevention of cognitive decline and dementia. Cochrane Database Syst. Rev. 2012; 6: CD005379.
  34. Reijmer Y.D., van den B.E., Ruis C., et al. Cognitive dysfunction in patients with type 2 diabetes. Diabetes Metab. Res. Rev. 2010; 26: 507-19.
  35. Luchsinger J.A., Reitz C., Patel B., et al. Relation of diabetes to mild cognitive impairment. Arch Neurol 2007; 64: 570-75.
  36. Cukierman T., Gerstein H.C., Williamson J.D. Cognitive decline and dementia in diabetes - systematic overview of prospective observational studies. Diabetologia. 2005; 48: 2460-69.
  37. Yaffe K., Blackwell T., Whitmer R.A., et al. Glycosylated hemoglobin level and development of mild cognitive impairment or dementia in older women. J. Nutr. Health Aging. 2006; 10: 293-95.
  38. Craft S., Baker L.D., Montine T.J., et al. Intranasal insulin therapy for Alzheimer disease and amnestic mild cognitive impairment: a pilot clinical trial. Arch. Neurol. 2012; 69: 29-38.
  39. Shemesh E., Rudich A., Harman-Boehm I., Cukierman-Yaffe T. Effect of intranasal insulin on cognitive function: a systematic review. J. Clin. Endocrinol. Metab. 2012; 97: 366-76.
  40. Feart C., Samieri C., Rondeau V., et al. Adherence to a Mediterranean diet, cognitive decline, and risk of dementia. JAMA. 2009; 302: 638-48.
  41. Folstein M.F., Folstein S.E., McHugh P.R. «Mini-mental state». A practical method for grading the cognitive state of patients for the clinician. J. Psychiatr. Res. 1975; 12: 189-98.
  42. Wechsler D. Manual for the Wechsler Adult Intelligence scale. New York: The Psychological Corporation, 1955.
  43. Wechsler D. The Wechsler Adult Intelligence Scale-Revised. New York: The Psychological Corporation, 1981.
  44. ACCORD Study Group, et al. Effects of intensive glucose lowering in type 2 diabetes. N. Engl. J. Med. 2008; 358: 2545-59.
  45. White W.B., et al. Examination of cArdiovascular outcoMes with alogliptIN versus standard of carE in patients with type 2 diabetes mellitus and acute coronary syndrome (EXAMINE): a cardiovascular safety study of the dipeptidyl peptidase 4 inhibitor alogliptin in patients with type 2 diabetes with acute coronary syndrome. Am. Heart J. 2011; 162: 620-26.
  46. Mosenzon O., et al. Baseline characteristics of patient population in the Saxagliptin Assessment of Vascular Outcomes Recorded in patients with diabetes mellitus (SAVOR) - TIMI 53 Trial. Diabetes Metab. Res. Rev. 2013 Apr 6. doi: 10.1002/dmrr.2413. [Epub ahead of print].

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