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Ueda2015 fasting diabetics is it a real challenge-dr.lobna el-toony

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Ueda2015 fasting diabetics is it a real challenge-dr.lobna el-toony

  1. 1. Moving Beyond Glycaemia Fasting Diabetics .... Is It A Real Challenge !?! Prof. Lobna ElToony Head of Internal Medicine & Diabetes Assuit University
  2. 2. ‫اليسر‬ ‫دين‬ ‫االسالم‬. . . ‫ر‬َ‫ف‬َ‫س‬ ‫ى‬َ‫ل‬َ‫ع‬ ْ‫و‬َ‫أ‬ ‫ا‬ً‫ض‬‫ي‬ ِ‫ر‬َ‫م‬ َ‫ان‬َ‫ك‬ ‫ن‬َ‫م‬َ‫و‬َّ‫ي‬َ‫أ‬ ْ‫ن‬ِ‫م‬ ٌ‫ة‬َّ‫د‬ِ‫ع‬َ‫ف‬‫ام‬ َ‫ر‬ْ‫س‬ُ‫ي‬ْ‫ال‬ ُ‫م‬ُ‫ك‬ِ‫ب‬ ُ‫اّلل‬ ُ‫د‬‫ي‬ ِ‫ُر‬‫ي‬ َ‫ر‬َ‫خ‬ُ‫أ‬ْ‫س‬ُ‫ع‬ْ‫ال‬ ُ‫م‬ُ‫ك‬ِ‫ب‬ ُ‫د‬‫ي‬ ِ‫ُر‬‫ي‬ َ‫ال‬َ‫و‬َ‫ر‬
  3. 3. Ramadan Between Diabetes and Fasting  Although the Koran exempts sick people from the duty of fasting, many Muslims with diabetes may not perceive themselves as sick and are keen to fast.  43% of patients with type 1 and 86% of those with type 2 diabetes fasted during Ramadan. EPIDIAR* study 1-IBRAHIM SALTI, et al . Diabetes Care 27:2306–2311, 2004 2-E Hui et al , BMJ, 26 june 2010 , Volume 340
  4. 4. Frequently asked questions during Ramadan  Can a diabetic patient fast?  What about diet and exercise?  How to adjust drugs?  Can a patient monitor blood sugar while fasting?
  5. 5. Can a diabetic patient fast during Ramadan?
  6. 6. The Risks of Fasting Include: Hypoglycemia Hyperglycemia Diabetic ketoacidosis Dehydration and thrombosis M. al-Arouj et al, “Recommendations for management of diabetes during Ramadan,” Diabetes Care, 28(2005), 2305-2311.
  7. 7. Ramadan Fasting and Diabetes Mellitus The bulk of literature indicates that fasting in Ramadan is safe for the majority of diabetic patients, but…
  8. 8. Patient needs- 1. Pre-Ramadan assessment 2. Proper education 3. Management
  9. 9. Pre- Ramadan Medical Assessment Management of Diabetic Patients During Ramadan Safer Fasting
  10. 10. High Moderate Low risk of adverse events •Poor glycemic control, Severe and recurrent episodes of hypoglycemia. • Experience ketoacidosis three months before Ramadan. • Elderly and Pregnant women • Advanced complications • Well controlled patients treated with short acting insulin secretogogue, sulphonylurea, insulin, or taking combination oral or oral plus insulin • Well controlled patients treated with Metformin, Dipeptidyl peptidase-4 inhibitors, or thiazolidinediones who are otherwise healthy Pre-Ramadan Medical Assessment E Hui et al , BMJ 2010;340:c3053; Al-Arouj M. et al, Recommendations for management of diabetes during Ramadan. Diabetes Care. 2010;33: 1895-1902. Patients classed as high risk are advised not to fast Before Ramadan they must make necessary changes to their diabetes treatment Those at low risk can fast without healthcare advice.
  11. 11. Salti E, et al. Diabetes Care 27:2306–2311, 2004
  12. 12. T2DM fasting during Ramadan are exposed to !?! 5 folds Increase in sever hyperglycemia with Ketoacidosis that required hospital admission 7.5 Folds Increase in the risk of sever hypoglycemia during Ramadan 2% Of fasting patients experienced at least one episode of sever hypoglycemia requiring hospitalization Salti E, et al. Diabetes Care 27:2306–2311, 2004
  13. 13. (4.7 fold) (7.5 fold)
  14. 14. Potential Complications and Effects of Severe Hypoglycemia 15 Plasma glucose level 10 20 30 40 50 60 70 80 90 100 110 1 2 3 4 5 6 mg/dL mmol/L 1. Landstedt-Hallin L et al. J Intern Med. 1999;246:299–307. 2. Cryer PE. J Clin Invest. 2007;117:868–870. Arrythmia1 Neuroglycopenia2  Abnormal prolonged cardiac repolarization — ↑ QTc and QT dispersion  Sudden death  Cognitive impairment  Unusual behavior  Seizure  Coma  Brain death
  15. 15. Severe Hypoglycemia Causes QT Prolongation P=NS P=0.0003 Landstedt-Hallin L et al. J Intern Med. 1999;246:299–307. Euglycemic clamp (n=8) Hypoglycemic clamp 2 weeks after glibenclamide withdrawal (n=13) 0 360 370 380 390 400 410 420 430 440 450 MeanQTinterval,ms Baseline (t=0) End of clamp (t=150 min) Significant QT prolongation During hypoglycemic attacks
  16. 16. Summary of Hypoglycemia Results From Major Clinical Trials: ACCORD, ADVANCE, and VADT1–3 No benefit of intensive vs standard glycemic control on macrovascular outcomes at the end of the prospective study Higher incidences of severe hypoglycemia in the intensive therapy arms Role of hypoglycemia in study outcomes is uncertain 17 1. ACCORD Study Group. N Engl J Med. 2008;358:2545–2559. 2. Duckworth W et al. N Engl J Med. 2009;360:129–139. 3. ADVANCE Collaborative Group et al. N Engl J Med. 2008;358:2560–2572.
  17. 17. The Occurrence of Hypoglycemia Was Associated With Negative Consequences Decreased adherence1 Increased worry/fear of hypoglycemia2,3 Lower quality of life4 Lower health-related quality of life5 Decreased work productivity6 1. Álvarez Guisasola FA et al. Diab Obes Metab. 2008;10 (suppl 1):25–32. 2. Mohamed M. Curr Med Res Opin. 2008;24:507–514. 3. Leiter LA et al. Can J Diabetes. 2005;29:186–192. 4. Pettersson B et al. Diabetes Res Clin Pract. 2011;92:19-25. 5. Álvarez Guisasola F et al. Health Qual Life Outcomes 2010;8:86–93. 6. Brod M et al. Value Health. 2011;14:665–671. 18
  18. 18. Dehydration and Thrombosis Limitation of fluid intake Hot and humid climates Hard physical labor Excessive perspiration. Hyperglycemia •Osmotic diuresis & •Volume and electrolyte depletion. Adapted from : M. al-Arouj et al, “Recommendations for management of diabetes during Ramadan,” Diabetes Care, 28(2005), 2305-2311.
  19. 19. Dehydration and Thrombosis • Patients with diabetes exhibit a hypercoagulable state due to an increase in clotting factors, a decrease in endogenous anticoagulants, and impaired fibrinolysis. • Increased blood viscosity secondary to dehydration may enhance the risk of thrombosis. • A report from Saudi Arabia suggested an increased incidence of retinal vein occlusion in patients who fasted during Ramadan M. al-Arouj et al, “Recommendations for management of diabetes during Ramadan,” Diabetes Care, 28(2005), 2305-2311.
  20. 20. DIABETES CARE, VOLUME 33, NUMBER 8, AUGUST 2010
  21. 21. Management of Diabetic Patients During Ramadan Patients Education T2DM Pharmaceutical Management in Ramadan
  22. 22. Four key areas in Ramadan focused education 1-Meal planning and dietary advice 2-Exercise 3-Blood glucose monitoring 4-Recognizing and managing complications E Hui et al , BMJ 2010;340:c3053;
  23. 23. Special precautions are recommended to avoid hypoglycemic events  To take Suhur close to Suhur time  To change in the schedule, amount and composition of meals  To reduce physical activity during the day time. However physical exercise can be performed about one hour after Iftar  To keep the same calorie during Ramadan as before
  24. 24. Management of diabetes during Ramadan 1. All patients should understand that they will need to break the fast if blood glucose is <3.3 mmol/L (59.4mg/dL) or exceeds 16.7 mmol/L (300mg/dL). They should be advised to break the fast if blood glucose is <3.9mmol/L in the morning if the patient is taking sulfonylurea or insulin 2. Nutrition: In terms of calori and composition diet should remain same healthy and balanced as before Ramadan. 3. Ingestion of large amount of foods rich in carbohydrate , fried food and fats during ifter should be avoided.
  25. 25. Nutrition At IFTARI. ,a date or water is the first thing to be eaten . A complex carbohydrate that delays in digestion and absorption is good choice for sheuri and while food with more simple carbohydrate may be taken during ifter. Eat fibre rich foods including whole grain carbohydrates , fruits and vegetables with skins. .
  26. 26. Exercise Avoid any physical activity that requires effort during the fasting hours especially the last few hours before “Iftar” because that could lead to hypoglycemia. Praying 5 times a day and the additional special night prayers (Taraweeh , which can last anything from 1-2 hours each night) is physical activity. It is advised that you test before and after prayers.
  27. 27. Benefits of Education & Counseling according to the READ study
  28. 28. REA D
  29. 29. Adjustment of Drugs
  30. 30. Before Ramadan During Ramadan Patients on “diet and exercise” - No change is needed - Modify time & intensity of exercise - Ensure adequate fluid intake Treatment Recommendations
  31. 31. Before Ramadan During Ramadan Sulfonylurea Once Daily: Morning dose. e.g., Gliclazide MR Glimepiride Iftar: Full Morning Dose Sulfonylurea Twice Daily: Morning & Evening dose. e.g., Gliclazide Glibenclamide Iftar: Full Morning Dose Suhur: ½ Evening Dose Treatment Recommendations Majority of our type 2 diabetic patients are treated with Sulfonylurea & Metformin
  32. 32. Before Ramadan During Ramadan Metformin 500 mg thrice daily Iftar: 1,000 mg, Suhur: 500 mg Treatment Recommendations
  33. 33. Before Ramadan During Ramadan DPP4 inhibitor As usual at night Glitazone As usual at night Glinide As usual at night Treatment Recommendations
  34. 34. Before Ramadan During Ramadan Premixed insulin 30 Morning: (30 U) Dinner: (20 U) Iftar: Full Morning Dose (30 U) Suhur: ½ Dinner Dose (10 U) Basal Analogue At the same time 20-30% dose reduction Split Mixed (R+N) R+0+R N+0+N R+0+50%of R N+0+50%of N R+R+R 0+0+N R+R+50% of R 0+0+50% of N Treatment Recommendations
  35. 35. Oral hypoglycemic agents Short acting insulin SUs Take twice daily at suhur and iftar TZDs No treatment adjustment required 2–4 weeks to exert substantial antihyperglycemic effects DPP4 inhibitors The best tolerated drugs, Consider DPP4i as an alternative to SUs if the risk of hypoglycemia is high SUs Unsuitable for use during fasting because of the inherent risk of Hypoglycemia, use with caution. Consider dose adjustment. Metformin Modify timing of doses: Two thirds of dose at iftar • One third at suhur. E Hui et al , BMJ, 26 june 2010 , Volume 340; Al-Arouj M. et al, Recommendations for management of diabetes during Ramadan. Diabetes Care.2010;33: 1895-1902. ADA Recomedndation for T2DM Pharmaceutical Management in Ramadan
  36. 36. Recommended changes to treatment regimen in patients with type 2 diabetes who fast during Ramadan (MONIRA AL-AROUJ, MD. RADHIA BOUGUERRA, MD. JOHN BUSE, MD, PHD. SHERIF HAFEZ, MD, FACP. MOHAMED HASSANEIN, FRCP. MAHMOUD ASHRAF IBRAHIM, MD. FARAMARZ ISMAIL-BEIGI, MD, PHD. IMAD EL-KEBBI, MD. OUSSAMA KHATIB, MD, PHD. SUHAIL KISHAWI, MD. ABDULRAZZAQ AL-MADANI, MD. ALY A. MISHAL, MD, FACP. MASOUD AL-MASKARI, MD, PHD. ABDALLA BEN NAKHI, MD. KHALED AL-RUBEAN, MD) Recommendations for Management of Diabetes During Ramadan; Reviews / Commentaries / ADA Statements ADA WORK GROUP REPORT; DIABETES CARE, VOLUME 28, NUMBER 9: 2305-2311, SEPTEMBER 2005
  37. 37. DPP-4 Inhibitors: Smart Mode of Action
  38. 38. DPP4 I Enhances Active Incretin Levels Through Inhibition of DPP-41–4 By increasing and prolonging active incretin levels, sitagliptin increases insulin release and decreases glucagon levels in the circulation in a glucose- dependent manner. Release of active incretins GLP-1 and GIPa  Blood glucose in fasting and postprandial states Ingesti on of food  Glucagon from alpha cells (GLP-1)  Hepatic glucose production GI tract DPP-4 enzym e Inactive GLP-1 XVildagliptin (DPP-4 inhibitor)  Insulin from beta cells (GLP-1 and GIP) Glucose- dependent Glucose- dependent Pancreas Inactive GIP Beta cells Alpha cells  Peripheral glucose uptake DPP-4=dipeptidyl peptidase 4; GI=gastrointestinal; GIP=glucose-dependent insulinotropic peptide; GLP-1=glucagon-like peptide-1. aIncretin hormones GLP-1 and GIP are released by the intestine throughout the day, and their levels increase in response to a meal. 1. Kieffer TJ et al. Endocr Rev. 1999;20(6):876–913. 2. Ahrén B. Curr Diab Rep. 2003;3(5):365–372. 3. Drucker DJ. Diabetes Care. 2003;26(10):2929–2940, 4. Holst JJ. Diabetes Metab Res Rev. 2002;18(6):430–441.
  39. 39. The goal remains......but The is glycaemic control “how?” and “whether we reach or not” is the question?
  40. 40. The challenge of blood glucose control in diabetes mellitus Hypoglycaemia/ weight gain HbA1c Jacob AN, et al. Diabetes Obes Metab 2007;9:386–93; Kahn SE, et al. N Engl J Med 2006;355:2427–43; Wright AD, et al. J Diabetes Complications 2006;20:395–401
  41. 41. Moving beyond glycaemia Challenges to reach target HbA1c goals
  42. 42. Targeting beyond glycaemia: challenges Sustainability Hypoglycaemia Confused Shaking Sweating Feels hungry Feels weak Adherence to therapy Helping patients stick to their therapy! Weight gain/obesity Diabesity: The new epidemic
  43. 43. Vildagliptin in Ramanda Does it add any benefits over Sulphonylurea !?!
  44. 44. A multinational non-interventional study to assess the effects of vildagliptin relative to sulphonylurea as dual therapy with metformin (or as monotherapy*) in Muslim patients with type 2 diabetes fasting during Ramadan *in countries with approved monotherapy Al-Arouj M, et al. Int J Clin Pract. 2013 Oct;67(10):957-63. Epub 2013 Sep 3 The VIRTUE study VildagliptIn expeRience compared wiTh sulfonylUreas obsErved during Ramadan
  45. 45. Egypt Bangladesh Pakistan Oman Lebanon Saudi Arabia Indonesia India Kuwait T2DM = Type 2 diabetes mellitus Al-Arouj M, et al. Int J Clin Pract. 2013 Oct;67(10):957-63. Epub 2013 Sep 3
  46. 46. †single pill combination allowed when available *if applicable, as per local approved prescribing information SU=sulphonylurea vildagliptin plus metformin† or vildagliptin monotherapy* SU plus metformin† or SU monotherapy* End of fasting period Start of fasting period 6 weeks before fasting 6 weeks after fasting Data collection opportunity 1 -6 weeks to day prior to start of fasting Data collection opportunity 2 End of studyFasting period approx. 4 weeks Observational period of approximately 16 weeks Two patient cohorts: Patients on stable diabetes treatment (1:1) Al-Arouj M, et al. Int J Clin Pract. 2013 Oct;67(10):957-63. Epub 2013 Sep 3
  47. 47. 0 20 40 60 80 100 120 140 Patients(n)with≥1 hypoglycaemicevent Vildagliptin (n=669†) SU (n=621†) ~3.5 -fold P<0.001‡ †Number of patients with a post baseline assessment of hypoglycaemic events. Hypoglycaemia defined as grade 1 (mild): reported symptoms by the patient and/or blood glucose measurement of <3.9 mmol/L (70 mg/dL) or grade 2 (severe): need for third party assistance ‡Fisher’s exact test Patients with ≥1 hypoglycaemic event Patients with grade 2 hypoglycaemic events SU = sulphonylurea 123 (19.8%) 36 (5.4%) Patients(n)withgrade2 hypoglycaemicevent 0 20 40 4 P=0.053‡ 0 Al-Arouj M, et al. Int J Clin Pract. 2013 Oct;67(10):957-63. Epub 2013 Sep 3
  48. 48. †The within and between treatment differences were based only on patients with HbA1c levels assessed at both baseline and end of study. ‡Two-sample t test –1 MeanchangeinHbA1c frombaseline(%) SUs (n=417†)Vildagliptin (n=485†) Between-treatment difference –0.24 0.02 –0.26 P<0.001‡ Mean change in HbA1c (%) pre- to post-Ramadan SU = sulphonylurea; HbA1c = haemoglobin A1c –0.5 0 0.5 Al-Arouj M, et al. Int J Clin Pract. 2013 Oct;67(10):957-63. Epub 2013 Sep 3
  49. 49. M. Hassanein, et al. Curr Med Res Opin 2011; 27:1367–74
  50. 50. Metformin 2000 + Gliclazide 80 mg* per daily n 36 Ramadan Metformin 2000 + Vildagliptin 50 mg bid daily n23 • Observational, two-cohort study, Conducted in the UK. • Primary objectives: The incidence of hypoglycemic events. • Secondary objectives: The change in HbA1c levels; The change in weight; and The treatment adherence during Ramadan. • The average duration of fasting in this study was 16 hours 6 weeks post Ramadan6weeks pre Ramadan *Different formulations were used for gliclazide therefore the following conversion factor was used: 80 mg standard formulation 30 mg modified release formulation. M. Hassanein, et al. Curr Med Res Opin 2011; 27:1367–74
  51. 51. 0 34 Number of Hypoglycemic Events Vildagliptin SU 0 1 Number of Severe Hypoglycemic Events Vildagliptin SU N=23 N=36 M. Hassanein, et al. Curr Med Res Opin 2011; 27:1367–74
  52. 52. MeanchangeinHbA1c pre-topost-Ramadan –0.5; P=0.0262 –0.4 (NS) 0.2 0.0 –0.2 –0.4 –0.6 0.1 (NS) Vildagliptin (n=20) SU‡ (n=32) Between-group difference HbA1c reduction for vildagliptin vs. gliclazide pre- to post Ramadan; between-group difference −0.5% (P=0.0262) Prospective observational study of up to 16 weeks duration in 72 fasting Muslim patients with T2DM observed in UK clinical practice, receiving vildagliptin or SU as an add-on treatment to metformin; per protocol set with pre- and post Ramadan HbA1c assessments, HbA1c; safety set, AEs and SAEs. ‡ SU = Sulfonylurea (gliclazide); VECTOR= Vildagliptin Experience Compared To gliclazide Observed during Ramadan; AE = adverse event; SAE = severe adverse event; NS = non-significant difference pre- to post Ramadan Hassanein M et al. Curr Med Res Opin 2011;27:1367–74 • Mean number of missed doses was lower with vildagliptin (mean between-group difference –7.4; P=0.0204) • Body weight remained unchanged in both groups
  53. 53. 1 Patient with vildagliptin 10 Patient with SU Significant difference in treatment adherence during Ramadan between the 2 groups (Number of patients missed at least one dose) Vs M. Hassanein, et al. Curr Med Res Opin 2011; 27:1367–74
  54. 54. Safety of Vildagliptin is Well Established • In meta – analysis of 38 clinical trials include more than 14.000 patients vildagliptin shows no increased risk of: • Pancreatitis-related AEs • ALT / AST or Bilirubin elevation • Renal AEs and SAEs in patients with normal renal function and mild renal impairment patients • Infection and skin related adverse events vs. comparators (placebo, insulin and other OAD) Ligueros-Saylan et al. DIABETES, OBESITY AND METABOLISM Volume 12 No. 6 June 2010
  55. 55. Today's Conclusion: Regardless The Stage of Diabetes, or Medical Condition, Vildagliptin Is Favorite Option For Better Glycemic Control
  56. 56. Last but not least... ADA considers DPP4 inhibitors as the best tolerated drugs in Ramadan Vildagliptin is well studied in Muslim patients during Ramadan supported by huge evidence for its efficacy and safety making it a very good option during fasting
  57. 57. Knowing is not enough We must APPLY! Willing is not enough We must DO!
  58. 58. Safe Fast LOBNA
  • MohammedAbuDayya1

    May. 16, 2018

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