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Terapia con insuline: “l’evoluzione della specie”

Terapia con insuline: “l’evoluzione della specie”. Limiti e rischi. Terapia insulinica: limiti. Insulin treatment and special populations. Insulin analogues are currently used for treating diabetic patients

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Terapia con insuline: “l’evoluzione della specie”

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  1. Terapia con insuline: “l’evoluzione della specie” Limiti e rischi

  2. Terapia insulinica: limiti

  3. Insulin treatment and special populations • Insulin analogues are currently used for treating diabetic patients • PK/PD profiles for specific insulin analogues may be altered in special patients populations such as elderly patients or children but also in special conditions such as pregnancy • Specific efficacy and safety data about the use of insulin analogues across the spectrum of special populations, although limited, should be considered when designing treatment regimens for special patient group

  4. Cura del diabete in popolazioni specifiche Standard Italiani per la cura del diabete mellito SID/AMD 2010.

  5. Terapia insulinica: indicazioni terapeutiche in sottogruppi di pazienti o condizioni patologiche specifiche Steatment sugli analoghi rapidi SID, AMD, SIEDP Giugno 2012

  6. Terapia insulinica: indicazioni terapeutiche in sottogruppi di pazienti o condizioni patologiche specifiche Riassunto della caratteristiche di prodotto Insulina Aspart, Insulina Glulisine, Insulina Lispro

  7. Terapia insulinica: indicazioni terapeutiche in sottogruppi di pazienti o condizioni patologiche specifiche Riassunto della caratteristiche di prodotto Insulina Detemir, Insulina Glargine

  8. Terapia insulinica: indicazioni terapeutiche in sottogruppi di pazienti o condizioni patologiche specifiche Riassunto della caratteristiche di prodotto Insulina Aspart, Insulina Glulisine, Insulina Lispro, Insulina Detemir, Insulina Glargine

  9. Diabetes in pregnancy and risk of complications Dunne et al. Diabetes Care 2009;32:1205–6

  10. Blood glucose control is linked with outcomes in diabetic pregnancy Diabetes Control and Complications Trial. Am J Obstet Gynecol 1996;174(4):1343–53

  11. Major Hypoglycemia in type 1 diabetic pregnancy

  12. Fetal and perinatal outcomes in type 1 diabetes pregnancy

  13. Major hypoglycaemia during pregnancy was similar with insulin detemir and NPH insulin NPH, neutral protamine Hagedorn Mathiesen et al. Diabetes Care 2012

  14. Composite fetal endpoint CI, confidence interval; GW, gestational week; IDet, insulin detemir; NPH, neutral protamine Hagedorn Hod et al. Diabetes 2011:Abstract 62-LB and and ADA 2011 poster presentation

  15. Farmaci in gravidanza: classificazione FDA Aspart Detemir Lispro Insulina umana Glargine Glulisine

  16. Terapia insulinica: indicazioni terapeutiche in sottogruppi di pazienti o condizioni patologiche specifiche Riassunto della caratteristiche di prodotto Insulina Aspart, Insulina Glulisine, Insulina Lispro, Insulina Detemir, Insulina Glargine

  17. Aspart in children aged 2–6 years Danne et al, Diabetes Care. 2003 Aug;26(8):2359-64

  18. Terapia insulinica: indicazioni terapeutiche in sottogruppi di pazienti o condizioni patologiche specifiche Riassunto della caratteristiche di prodotto Insulina Aspart, Insulina Glulisine, Insulina Lispro, Insulina Detemir, Insulina Glargine

  19. Preserved pharmacokinetic profile of insulin aspart vs. human insulin in the elderly IAsp RHI 800 * 700 600 NS 500 Exogenous serum insulin (pmol/l) 400 300 200 100 0 60 120 180 240 300 360 420 480 540 Nominal time (min) *= AUCINS(0-300 min) was greater with IAsp than RHI (p<0.0001) Krones et al. Diabetes Obes Metab 2009;11(1):41-4.

  20. Insulina detemir nei soggetti anziani con diabete tipo 2

  21. Terapia insulinica: indicazioni terapeutiche in sottogruppi di pazienti o condizioni patologiche specifiche Riassunto della caratteristiche di prodotto Insulina Aspart, Insulina Glulisine, Insulina Lispro, Insulina Detemir, Insulina Glargine

  22. Mean plasma concentration vs. time for insulin aspart by degree of renal impairment 60 Normal Mild Moderate Severe 50 concentration (mU/L) 40 Mean insulin aspart 30 20 10 0 0 200 400 600 800 1000 1200 14001600 Time (mins) • Regression analyses showed no significant difference in PK endpoints between normal and variable degrees of renal impairment • Ln(Cmax), ln(AUC0-360) and t1/2(mins): p=0.92, p=0.78 and p=0.65, respectively. Holmes et al. Br J Clin Pharmacol 2005;60(5):469-76

  23. Pharmacokinetics of Insulin Detemir in Subjects with Renal Impairment L.V. Jacobsen1, G. Popescu2, A. Plum3 1Copenhagen, Denmark; 2Munich, Germany; and 3Copenhagen, Denmark

  24. Terapia insulinica: indicazioni terapeutiche in sottogruppi di pazienti o condizioni patologiche specifiche Riassunto della caratteristiche di prodotto Insulina Aspart, Insulina Glulisine, Insulina Lispro, Insulina Detemir, Insulina Glargine

  25. Terapia insulinica: rischi

  26. 1,3 eventi / anno / paziente • Il 36,7% con almeno un episodio, il 21,3% con due o più episodi • Il 5% giustifica il 54% degli episodi, il 10% il 69% • 0,44 eventi / anno / paziente • 16,5% con almeno un episodio Pedersen-Bjergaard U. et al, Diabetes Metab Res Rev (2004) 20: 479-86 Akram K. et al, Diabet Med (2006) 23: 750-6

  27. Epidemiology of hypoglycaemia in UK SU, sulphonylurea UK Hypoglycaemia Study Group. Diabetologia 2007;50:1140–7

  28. Impaired awareness of hypoglycaemia is associated with higher rate of severe hypoglycaemia (type 1 or type 2) Incidence of severe hypoglycaemia in individuals with impaired awareness of hypoglycaemia Graveling & Frier. Diabetes Metab 2010;36(Suppl. 3):S64–74

  29. Patient fear of hypoglycaemia increases with increased severity of hypoglycaemia HFS: Hypoglycaemia Fear Survey Marrett et al. Diabetes 2008;57(suppl. 1):A174

  30. Patients rank fear of severe hypoglycaemia as high as fear of developing chronic complications *Based on patient (n=411, type 1 diabetes) attitudes to hypoglycaemia using a visual analogue scale Pramming et al. Diabetes Med 1991;8:217–22

  31. Hypoglycaemia represents a psychological barrier to effective glycaemic control • Physicians and patients express fear of hypoglycaemia, which may impede effective diabetes management1 • To avoid hypoglycaemia, some patients intentionally maintain a state of hyperglycaemia2 • Fear of hypoglycaemia extends to family members2 • Hypoglycaemia are associated with significantly lower treatment satisfaction and barriers to adherence3 1. Nakar et al. J Diabetes Complications 2007;21:220–6; 2. Frier. Diabetes Metab Res Rev 2008;24:87–92; 3. Alvarez Guisasola et al. Diabetes Obes Metab 2008;10(Suppl. 1):25–32

  32. Higher rate of severe hypoglycaemia with intensive glycaemic control* *Intensive glycaemic control was defined differently in these trials †Hypoglycaemia requiring any assistance in glucose-lowering trials Conv, conventional therapy; gly, glibenclamide; HR, hazard ratio; ins, insulin; int, intensive therapy; std, standard therapy 1. UKPDS Group. Lancet 1998;352:837–53; 2. Patel et al; ADVANCE Collaborative Group. N Engl J Med 2008;358:2560–72; 3. Gerstein et al; ACCORD Group. N Engl J Med 2008;358:2545–59; 4. Duckworth et al. N Engl J Med 2009;360:129–39

  33. Int. Diab. Monitor, 2009;21(6):210-218

  34. Adverse outcomes among patients with type 2 diabetes experiencing severe hypoglycaemia Zoungas. N Engl J Med 2010;363:1410–8, for the ADVANCE Collaborative Group

  35. Link between hypoglycaemia and acute cardiovascular events in type 2 diabetes • Retrospective, observational study (n=860,845) assessing association between hypoglycaemic events and acute cardiovascular events • 3.1% patients had a hypoglycaemic event during the evaluation period (1 year) • Patients with hypoglycaemic events had 79% higher odds of acute cardiovascular events than patients without hypoglycaemic events Johnston et al. Diabetes Care 2011;34:1164–70

  36. Pathophysiological cardiovascular consequences of hypoglycaemia CRP, C-reactive protein; IL-6, interleukin 6 VEGF, vascular endothelial growth factor Desouza et al.Diabetes Care 2010;33:1389–94

  37. Abnormalities in: • atrioventricular conduction • ventricular depolarisation • ventricular repolarisation • R-wave amplification associated with norepinephrine counter-regulatory response • T-wave flattening associated with epinephrine counter-regulatory response Int. Diab. Monitor, 2009;21(6):210-218 Laitinen et al. Ann Noninvasive Electrocardiol 2008;13:97–105

  38. Cardiovascular mortality In trials in which the reduction of HbA1c was obtained with a higher incidence of hypoglycaemia, CV MORTALITY is increased

  39. Multiple logistic regression of acute CV events as a function of hypoglycaemic events Johnston et al. Diabetes Care 2011;34:1164–70

  40. Hypoglycemia Rates with Basal Insulin Analogs Little et al., Diab Tech & Ther 2011, Volume 13, Supplement 1, S53

  41. Relationship of hypoglycaemia rate and HbA1c target NPH Basal Insulin Analogues Target Profile Basal Insulin Analogues Basal Insulin Analogues Adapted from Kolendorf et al. Diabetes 2005; 54 (Suppl 2): P489

  42. Conclusion Hypoglycaemia is: • a common side effect of diabetes treatment in both type 1 and type 2 diabetes • feared by both physicians and patients • linked with cardiovascular and neurological pathophysiology • a barrier to effective glycaemic management

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