Diabetes and ramadan. K. Abdallah (Egypt)

Transcription

1 Diabetes and ramadan K. Abdallah (Egypt)

2 Diabetes and Ramadan Khalifa Abdallah Professor of Internal Medicine Unit of Diabetes & Metabolic Diseases Alexandria Faculty of Medicine Istanbul 9 MAY 2015

3 Disclosure I have received honoraria for lectures and Advisory Boards with Eli-Lilly, Novartis Pharmaceuticals, Astra Zeneca, GSK, Novo Nordisk, Servier, Boehringer Ingelheim, Pfizer, Merk Sorono, Merck Sharp & Dohme Limited, Sanofi-Aventis and Abbott

4 Presentation overview Introduction Pre-Ramadan preparation Management of patients with type 1 diabetes Management of patients with type 2 diabetes - OADs - Insulin Conclusions

5 Islam: Fasting in Ramadan Fasting the holy month of Ramadan is one of the five pillars of Islam. Fasting hours may range from just 9 in Argentina up to 20 in Sweden during which no food or drink may be consumed between dawn and sunset

6 Fasting & Type 2 Diabetes Major risks Hypoglycaemia Hyperglycaemia Dehydration (including thromboembolism)

7 EPIDIAR study: fasting during Ramadan increases the risk of severe hypoglycaemia and hyperglycaemia in patients with T2DM 11,173 patients with T2DM; 78.7% chose to fast for at least 15 days during Ramadan 1 Higher risk of severe hypoglycaemic events Higher risk of severe hyperglycaemic events in overall population during Ramadan 1,2 in overall population during Ramadan 1,2 P< P< Incidence (events/100 patients/month) 7.5-fold increase* 5-fold increase Pre-Ramadan During Ramadan Events requiring hospitalization in overall population with T2DM; Compared with previous months *There was a 7.5 fold difference of hypoglycaemia in overall population fasting during Ramadan. For patients who fasted for > 15 days difference was 6.7 fold EPIDIAR = EPIdemiology of DIAbetes and Ramadan; T2DM = type 2 diabetes mellitus 1 Salti I et al. Diabetes Care 2004;27: ; 2 Al-Arouj M et al. Diabetes Care 2010;33:

8 The majority of Muslim diabetics insist to fast According to the Islamic law, when fasting may significantly affect health of faster or when one is sick, Islam exempts him/her from fasting In spite of the permission of religious authorities and the advice from the treating doctors, the majority of adult Muslims insist to fast during Ramadan creating a medical challenge for them and their health care providers. DIABETES CARE, VOLUME 27, NUMBER 10, OCTOBER 2004

9 The Dilemma for Physicians and Muslim Scholars is whether or not Muslim Diabetic Patients: Would be allowed to fast if they decide to Can be guided to fast safely if they insist to

10 DIABETES CARE, VOL 33, No 8, AUG 2010 Ind J Endocrin & Metab 2014;16(4): Ind J Endocrin & Metab 2014;18(6):794 99

11 Presentation overview Introduction Pre-Ramadan Preparation Management of patients with type 1 diabetes Management of patients with type 2 diabetes - OADs - Insulin Conclusions

12 Pre-Ramadan preparation for diabetic patients Pre-Ramadan medical individualized assessment: Risk stratification Experience from previous Ramadan Structured education for patients willing to fast: Diet and exercise Urine testing for ketones Symptoms of hypoglycemia and dehydration SMBG Breaking the fast Ind J Endocrin & Metab 2014;18(6):794 99

13 Recommendations for Management of Diabetes During Ramadan Categories of risk in diabetic patients who fast during Ramadan Very high risk Type 1 diabetes Severe hypoglycemia within the 3 months prior to Ramadan A history of recurrent hypoglycemia Hypoglycemia unawareness Ketoacidosis within the 3 months prior to Ramadan Hyperosmolar hyperglycemic coma within the previous 3 months Sustained poor glycemic control Acute illness Performing intense physical labor Pregnancy Chronic dialysis DIABETES CARE, VOLUME 33, NUMBER 8, AUGUST 2010

14 Recommendations for Management of Diabetes During Ramadan Categories of risk in diabetic patients who fast during Ramadan High risk Moderate hyperglycemia (average blood glucose mg/dl or A1c ( 7.5-9%) Renal insufficiency Advanced macrovascular complications Living alone and treated with insulin or sulfonylureas Patients with comorbid conditions that present additional risk factors Old age with ill health Treatment with drugs that may affect mentation Moderate risk Well-controlled diabetes treated with short-acting insulin secretagogues Low risk Well-controlled diabetes treated with lifestyle therapy, metformin, acarbose, thiazolidinediones, and/or incretin-based therapies in otherwise healthy patients DIABETES CARE, VOLUME 33, NUMBER 8, AUGUST 2010

15 SMBG during Ramadan for patients on insulin therapy Low/moderate-risk High-risk group group Pre-Suhur Midday 2 hours post-suhur Pre-Iftar Midday Whenever Pre-Iftar symptoms of hypoglycaemia 2 hours post-iftar occur Whenever symptoms of hypoglycaemia occur 4:00 8:00 12:00 16:00 20:00 24:00 4:00 8:00 SMBG, self-measured blood glucose Hassanein M, et al. Ind J Endocrin & Metab 2014;18(6):794 99

16 Presentation overview Introduction Pre-Ramadan Preparation Management of patients with type 1 diabetes Management of patients with type 2 diabetes - OADs - Insulin Conclusions

17 Can patients with type 1 diabetes fast? Fasting during Ramadan has been uniformly discouraged by the medical profession for individuals with type 1 diabetes 43% of individuals with type 1 diabetes do fast. 1 Due to the long hours of fasting, the main concern is the associated increased risk oh hypoglycemia, hyperglycemia and ketoacidosis EPIDIAR study. Diabetes Care 2004;27:

18 Ramadan Fasting and Type 1 Diabetes Mellitus Adolescents with T1DM usually insist on fasting during Ramadan, not only for religious motives but also for social and psychological reasons especially to avoid the feeling of being different or handicapped.

19 Ramadan Fasting and Type 1 Diabetes Mellitus Few studies with small number of patients Most of the studies showed no episodes of hypoglycemia or DKA that required hospitalization. 1,2,3 1. LMJ 2008;56:46 2. J Endocrinol Invest. 2005;28: Intern J Diabetes in Developing Countries 2011;31(4):

20 Ramadan Fasting and Type 1 Diabetes Mellitus Individuals with type 1 diabetes in whom fasting is not recommended Poorly controlled patients Those with limited access to medical care Hypoglycemic unawareness Unstable glycemic control, or Recurrent hospitalizations. Patients who are unwilling or unable to monitor their blood glucose levels several times daily

21 Presentation overview Introduction Pre-Ramadan Preparation Management of patients with type 1 diabetes Management of patients with type 2 diabetes - OADs - Insulin Conclusions

22 Antihyperglycemic medications Metformin. Alpha glucosidase inhibitors. Glitazones. DPP-4 inhibitors. SGLT2 inhibitors GLP-1 analogues Sulfonylureas Short-acting insulin secretagogues Insulin No change in dose is needed

23 Sulfonylureas and Ramadan fasting Sulfonylureas is known to be associated with increased risk of hypoglycemia Does this risk further increase during Ramadan fasting? Do all members of SU class have the same hypoglycemic risk?

24 Hypoglycaemia in sulphonylurea-treated subjects with type 2 diabetes undergoing Ramadan fasting: a five-country observational study Objectives: To determine the incidence of hypoglycaemia during Ramadan in Muslim subjects with type 2 diabetes treated with a sulphonylurea Design: Observation study ( n= 1397) Subjects were recruited by clinicians in India, Malaysia, Israel, the United Arab Emirates (UAE), and Saudi Arabia. Inclusion Criteria: Muslims with type 2 diabetes who were treated with glimepiride, gliclazide, or glibenclamide with or without metformin and who expressed their intention to fast during Ramadan Outcome: The overall incidence of symptomatic hypoglycaemia recorded during Ramadan Current Medical Research & Opinion Vol. 27, No. 6, 2011,

25 Hypoglycaemia in sulphonylurea-treated subjects with type 2 diabetes undergoing Ramadan fasting: a five-country observational study Incidence of hypoglycemia by country Incidence of hypoglycemia by type and drug used Country Incidence % Symtomatic % Documented % Severe % Israel Malaysia UAE India Saudi Arabia Glibenclamide Glimepride Gliclazide Overall N.B. The incidence of hypoglycaemia with sulphonylurea treatment was not assessed before or after Ramadan. Current Medical Research & Opinion Vol. 27, No. 6, 2011,

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27 Aim: To determine which non-insulin glucose-lowering treatment regimens are most appropriate in people with type 2 diabetes who choose to fast during Ramadan. Methods: Electronic databases were searched for randomised controlled trials (RCT) and observational studies comparing non-insulin glucose lowering agents in people with type 2 diabetes fasting during Ramadan reporting hypoglycaemia, weight and HbA1c change were included. Data were pooled using random effects models. Results: A total of 16 studies were included: 9 RCTs and 7 observational studies. There was evidence that (DPP-4) inhibitors led to fewer hypoglycaemic events compared with sulphonylureas. Conclusions: The analysis supports the use of DPP-4 inhibitors during Ramadan rather than sulphonylureas for reduction in hypoglycaemia without a cost to diabetes control and weight

28 Do all the members of SU class have the same hypoglycemic risk during Ramadan?

29 Multicenter randomized trial Patients:1066 fasting Ramadan Primary endpoint: the incidence of symptomatic hypoglycemia during Ramadan J Clin Pract, November 2011, 65, 11,

30 The incidence of hypoglycaemia in Muslim patients with type 2 diabetes treated with sitagliptin or a sulphonylurea during Ramadan Results J Clin Pract, November 2011, 65, 11,

31 The incidence of hypoglycaemia in Muslim patients with type 2 diabetes treated with sitagliptin or a sulphonylurea during Ramadan: a randomized trial J Clin Pract, November 2011, 65, 11,

32 Multicenter randomized trial. Patients:870 fasting Ramadan. Primary endpoint: the overall incidence of symptomatic hypoglycemia during Ramadan. Aravind SR et al. Curr Med Res Opin. 2012;28:

33 p = NS Gliclazide 60 MR Aravind SR et al. Curr Med Res Opin. 2012;28:

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35 STEADFAST Study Results Vascular Health and Risk Management 2014:

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37 Presentation overview Introduction Pre-Ramadan Preparation Management of patients with type 1 diabetes Management of patients with type 2 diabetes - OADs - Insulin Conclusions

38 Physiological serum insulin secretion profile Breakfast Lunch Dinner Non-fasting state Plasma insulin (µu/ml) 4:00 8:00 12:00 16:00 20:00 24:00 4:00 Iftar Suhur Ramadan fasting 20:00 24:00 4:00 8:00 12:00 16:00 20:00

39 Patients on basal-oral therapy Oral agents Iftar Suhur NPH or Premix Insulin Hypoglycemia 20:00 24:00 4:00 8:00 12:00 16:00 20:00 Algorithm for self-titration of basal insulin during Ramadan 1 Fasting/pre-Iftar BG Basal insulin dose <70 mg/dl or symptoms Break the fast and down titrate <90 mg/dl mg/dl >126 mg/dl >300 mg/dl 2 IU No change +2 IU Break the fast and increase dose by 4 units and check for ketones Ind J Endocrin & Metab 2014;18(6):794 99

40 Patients on basal-oral therapy Oral agents Iftar Suhur Long-acting insulin analogue 20:00 24:00 4:00 8:00 12:00 16:00 20:00

41 Use of pre-mixed insulin during Ramadan Breakfast Lunch Dinner Non-fasting state Plasma insulin (µu/ml) 4:00 8:00 12:00 16:00 20:00 24:00 4:00 Iftar Suhur Ramadan fasting 20:00 24:00 4:00 8:00 12:00 16:00 20:00

42 Use of pre-mixed insulin during Ramadan Breakfast Lunch Dinner Non-fasting state Plasma insulin (µu/ml) 4:00 8:00 12:00 16:00 20:00 24:00 4:00 Iftar Suhur Ramadan fasting 25-50% 20:00 24:00 4:00 8:00 12:00 16:00 20:00

43 Use of pre-mixed insulin during Ramadan Breakfast Lunch Dinner Non-fasting state Plasma insulin (µu/ml) 4:00 8:00 12:00 16:00 20:00 24:00 4:00 Iftar Suhur Ramadan fasting Premix 50 20:00 24:00 4:00 8:00 12:00 16:00 20:00

44 Basal-bolus insulin regimen during Ramadan Rapid-acting insulin analogue Long-acting insulin analogue 4:00 8:00 12:00 16:00 20:00 24:00 4:00 Time 8:00 Pathan MF, et al. Ind J Endocrin & Metab 2012;16(4):

45 Presentation overview Introduction Pre-Ramadan Preparation Management of patients with type 1 diabetes Management of patients with type 2 diabetes - OADs - Insulin Conclusions

46 Conclusions Fasting during Ramadan by a Muslim diabetic is not an Islamic obligation The decision for fasting should be individualized Most type 2 diabetic patients with stable metabolic control on diet or OHA and without advanced vascular complications can fast safely Patients on insulin therapy have to re-adjust insulin regimen before fasting Patient education is the cornerstone for safe fasting Large well-designed studies are needed to assess the impact of fasting on people with diabetes and to define the best approach for management during the holy month of Ramadan.

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