WHO Guidelines for Management of Diabetes in Low Resource Settings 24 th November, 2018 Dr. Alok Shetty K Senior Resident Department of Medicine St. John s Medical College & Hospital
WHO vs ADA-EASD
Revisiting the previous case>>>> Patient 62 year old, smoker, admitted with NSTEMI, HbA1c 10.6(newly detected), with HFrEF and egfr 58%. Patient planned for discharge. What medications? Combination Metformin + GLP-1RA /Basal Insulin Can consider SGLT2, DPP4 THEORY
REALITY>>>>>>>> Husband and wife stay alone. Separated from children Only income from a rented house One son is drunkard who takes away the little income that they earn Both husband and wife illiterate Husband has bilateral cataract with probable retinopathy- Poor vision
Money Matters!!! >>Total annual expenditure for a diabetic patient was on average- ~ Rs.10,000 in Urban areas ~ Rs.6260 in Rural areas >>India:85%-95% of health care costs borne by individuals and families. >>Multiple factors are involved-direct + Indirect Costs Economic Burden ofdiabetes-apiupdate-2013
Some countries- Documented expenditures on insulin analogues surpassed the total budget for insulin, leading to shortages of insulin for part of the diabetic population that needed it. * Study of 35 developing countries found that people with diabetes had a substantially higher risk of incurring catastrophic personal medical expenditure. ** *El Naggar N, Kalra S. Switching from biphasic human insulin to premix insulin analogs: a review of the evidence regarding quality of life and adherence to medication in type 2 diabetes mellitus. Advances in Therapy. 2017;33(12):2091 109. **Davies MJ et al Real-world factors affecting adherence to insulin therapy in patients with type 1 or type 2 diabetes mellitus: a systematic review. Diabetic Medicine. 2013;30(5):512 24. s than their peers without diabetes.
Drug Cost per tablet GLICLAZIDE Rs.3.95 GLIMEPIRIDE Rs. 3.77 GLIPIZIDE Rs. 1.61 VILDAGLIPTIN Rs. 26.52 TENELIGLIPTIN Rs. 10.12 CANAGLIFLOZIN Rs. 54.90
Ann Intern Med. 2018;169:394-7.
AIM of the guidelines--- Provide public health guidance on pharmacological agents for managing hyperglycaemia in type 1 and type 2 diabetes for use in primary health-care in low-resource settings.
To Update WHO Package of Essential NCD Interventions (WHO PEN)-2013 --Considering newer evidence and medications for Diabetes Integrating services at the primary care level Task sharing Introducing simple clinical monitoring Simplified drug formularies Providing care and drugs free of charge
OBJECTIVE To consider the use of DPP-4 inhibitors, SGLT-2 inhibitors, and TZDs as 2 nd line and 3 rd line treatment after metformin & sulfonylurea for controlling hyperglycaemia in type 2 diabetes in non-pregnant adults, including whether these oral agents are preferable to insulin. To provide guidance regarding the use of insulin analogues for type 1 and type 2 diabetes.
TARGET POPULATION of the guidelines Policy makers Relief Workers National Diabetes Programme Managers NGOs Guideline Makers in low income countries
Recommendation1 Second line medications Recommendation2 Third Line Medications Recommendation 3 Recommendation 4 Recommendation 5 When and which insulin to use
RECOMMENDATION 1 Give a sulfonylurea to patients with type 2 diabetes who do not achieve glycemic control with metformin alone or who have contraindications to metformin Strong recommendation Moderate-quality evidence
Remarks:::: Glibenclamide- Should be avoided in patients aged 60 years and older. SUs with a better safety record for hypoglycaemia (e.g. gliclazide) - Preferred in patients for whom hypoglycaemia is a concern. Individualized approach is encouraged in setting the patient s target level for glycaemic control. --co-morbidities adverse effects -life expectancy
GUIDELINE GROUP thoughts:::: With respect to new drugs more evidence is needed to determine whether this is a class effect and whether there is a cardio-protective effect in the general population of people with type 2 diabetes. Lack of RCTs on how each new drug class compares with all the others (particularly new agents vs. old ones) and concluded that the evidence reviewed did not convincingly show the superiority or inferiority of any one class.
New OHAs are currently substantially more expensive compared to sulfonylureas, & the modest clinical benefit does not sufficiently outweigh the current price difference in the context of a public health approach. Industry-funded cost-effectiveness studies tended to report that new treatments were cost-effective while the only independent study favoured sulfonylurea.
RECOMMENDATION 2 Introduce human insulin treatment to patients with type 2 diabetes who do not achieve glycemic control with metformin and/or a sulfonylurea Strong recommendation Very-low-quality evidence
RECOMMENDATION 3 If insulin is unsuitable*, a dipeptidyl peptidase-4 (DPP-4) inhibitor, a sodium glucose cotransporter-2 (SGLT-2) inhibitor, or a thiazolidinedione (TZD) may be added Weak recommendation Very-low-quality evidence *(e.g. persons who live alone and are dependent on others to inject them with insulin).
GUIDELINE GROUP thoughts:::: Patient preference for newer oral agents was not deemed a sufficiently strong reason to recommend them in the context of a public health approach because the price of newer oral medicines is currently higher than that of human insulin. Insulin treatment has further associated resource implications such as needles and blood glucose self-monitoring.
RECOMMENDATION 4 Use human insulin to manage blood glucose in adults with type 1 diabetes and in adults with type 2 diabetes for whom insulin is indicated Strong recommendation Low-quality evidence The recommendation is strong because evidence of better effectiveness of insulin analogues is lacking and human insulin has a better resource-use profile.
RECOMMENDATION 5 Consider long-acting insulin analogues to manage blood glucose in adults with type 1 or type 2 diabetes who have frequent severe hypoglycemia with human insulin Weak recommendation, Moderate-quality evidence for severe hypoglycemia weak recommendation reflecting the lack of, or very low-quality evidence for, any of the long-term outcomes such as chronic diabetes complications and mortality, and the considerable higher costs for long-acting insulin analogues compared to intermediate-acting human insulin.
GUIDELINE GROUP thoughts:::: In the absence of universal health coverage, insulin analogues are far more expensive for patients paying out-of-pocket. Although short-acting insulin analogues statistically significantly reduced HbA1c compared to short-acting human insulin, the Guideline Group did not consider this to be a clinically meaningful reduction according to criteria widely used in clinical guidelines and recommendations of medicines licensing bodies.
SUMMARY In low resource settings cost is a major concern while deciding treatment regimens in patients. On a community level, cost benefit outcomes need to be strongly considered while preparing local guidelines.
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