Prescription Restrictions on Antidiabetics Authorized for Prescription by General Practitioners - Status as of October 2020
Diabetes mellitus (DM) has become an increasing problem worldwide in recent years. Long-term complications of DM lead to increased morbidity and mortality in the diabetic population, and their prevention determines the main treatment goals of DM. The treatment and management of patients with type 2 diabetes (DM2) are provided by either a general practitioner's office (GP) or a diabetology clinic. According to available data, over 200,000 patients with DM2 are currently treated and managed in GP offices.
Pharmacotherapy of Type 2 DM in General Practitioners' Offices
Metformin
The first-line drug for type 2 diabetes patients has long been metformin, with other antidiabetics only being considered after treatment with this drug fails. Metformin is indicated for all patients with DM2 and recommended by professional organizations (Czech Diabetes Society ČLS JEP /ČDS/, Society of General Practice ČLS JEP /SVL/, European Association for the Study of Diabetes /EASD/, American Diabetes Association /ADA/) even for individuals with prediabetes.
Sulfonylurea Derivatives (glimepiride, gliclazide, glipizide, gliquidone)
In recent years, based on the views of professional organizations (ADA, EASD, ČDS), sulfonylurea derivatives have been recommended as 2nd to 5th alternatives in combination therapies. They are inexpensive, long-used, and effective, but considering safety and efficacy, new antidiabetics with an incretin effect (GLP-1 analogues or gliptins), gliflozins, or glitazones should currently be preferred in combination therapy with metformin for patients with DM2. Unfortunately, this algorithm is not fully adhered to in practice due to various prescription and economic limitations.
DPP-4 Inhibitors – Gliptins (sitagliptin, vildagliptin, saxagliptin, linagliptin, and alogliptin)
Antidiabetics with an incretin effect are either analogues of glucagon-like peptide 1 (GLP-1) or gliptins, which are inhibitors of the enzyme dipeptidyl peptidase 4 (DPP-4), which physiologically inactivates GLP-1. This promising group of drugs improves insulin secretion from pancreatic β-cells via a hyperglycemia-dependent mechanism, additionally leading to suppression of glucagon secretion, delayed gastric emptying, and reduced appetite. A key advantage is that they do not induce hypoglycemia. Linagliptin is unique in this group as it is not excreted renally, making it suitable for patients with severe renal insufficiency, including those on dialysis.
This group of antidiabetics, however, is subject to strict prescription restrictions. They can only be prescribed in combination with metformin or with metformin and sulfonylurea, for patients where treatment with maximum tolerated doses of metformin or metformin and sulfonylurea for at least 3 months, along with lifestyle measures, did not result in satisfactory diabetes control defined as glycated hemoglobin (HbA1c) < 60 mmol/mol. If there is no demonstrable improvement in diabetes compensation by 7% or a higher reduction in HbA1c levels after 6 months of treatment, these medications are no longer reimbursed. They are not reimbursed at all when combined with insulin.
Conclusion
The choice of suitable antidiabetic medication must be individualized for each patient, taking into account coexisting conditions and their limitations regarding oral antidiabetic treatment.
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Sources:
1. Karen I., Svačina Š. Diabetes mellitus. Updates 2020. Recommended Diagnostic and Therapeutic Procedures for General Practitioners. Society of General Practice ČLS JEP, 2020. Available at: www.svl.cz/files/files/Doporucene-postupy/2020/DIABETES-MELLITUS-2020.pdf
2. State Institute for Drug Control. Drug Database. Prices and Reimbursements. SÚKL, 2020 (status as of October 10, 2020). Available at: www.sukl.cz
We also recommend the article "Practical Diabetology" Seminar: News, Principles, and Pitfalls of Diabetes Care in GP Offices.
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