The Real-Life Effectiveness and Care Patterns of Diabetes Management Study for the Balkan Region – a Report on the Bulgarian Dataset

Author: Totomirova, Tzvetelina T.1, Arnaudova, Mila V.1, Vladeva, Stefka V.2, Lefterov, Ivaylo N.3, Djurov, Kalin K.4

1. Clinic of Endocrinology and Metabolic Diseases, MMA, Sofia
2. Clinic of Endocrinology and Metabolic Diseases, University Hospital Kaspela, Plovdiv
3. Department of Endocrinology, 5 MHAT, Sofia
4. Merck, Sharp and Dome, Bulgaria

Author: Sheytanova, Tanya Z.1, Zarkova, Violeta L.1, Orbetzova, Maria M.2, Genchev, Gencho D.3

1. Doping Control Laboratory, Antidoping Centre
2. Clinic of Endocrinology and Metabolic Diseases, “Sveti Georgy” University Hospital, Department of Endocrinology, Medical Faculty, Medical University, Plovdiv
3. Department of Healthcare Economics, Faculty of General Healthcare, Medical University, Sofia



Aim: A multicenter, observational, crossover study RECAP-DM (real-life effectiveness and care patterns of diabetes management) (Bulgarian arm) involving patients with type 2 diabetes mellitus (type 2 DM) treated with sulphonylurea (SU) as monotherapy or in combination with metformin 6 months before study participation

Materials and Methods: To evaluate the incidence of adverse events of SU therapy such as hypoglycaemia and to assess the change in weight among Bulgarian ts were evaluated at the final analysis – 57 (42,2%) men and 78 (57,8%) women. Mean age – 66,1 ± 10,2 years. Average disease duration was 10,0 ± 6,9 years. 58 (43%) patients were on monotherapy with SU and 77 (57%) patients on dual therapy (metformin + SU). Patients received questionnaires regarding adherence, self-care, hypoglycaemic episodes, weight gain and fear, and the standardized HFS-II Questionnaire Worry Subscale.

Results: According to the American Diabetes Association (ADA) criteria, 54.8% were well controlled with an HbA1c of <7%, and based on fasting plasma glucose (FPG < 7,2 mmol/l) – 36,1%. Based on both criteria, 24,4% achieved good control. According to the International Diabetes Federation (IDF) criteria for optimal control (HbA1c <6,5%; FPG < 6,1 mmol/l), the results are as follows: based on HbA1c – 36,3%, based on fasting plasma glucose – 16,7%, and based on both criteria in 12 patients (8,0%) reached optimal control. 24,4% of patients reported symptoms of low blood sugar in the last 6 months. 78,8% were concerned about the symptoms of hypoglycemia during this period. There was weight gain in 29,6% for the last year period. 81,3% of patients reported anxiety about the symptoms of hypoglycemia.

Conclusion: Hypoglycaemic episodes are an important side effect of SU treatment in patients with type 2 diabetes. The incidence and severity of hypoglycaemia has been associated with an increased fear of lowering of blood glucose. Precise adjustment in therapy is required by each physician to achieve optimal efficacy and safety for patients.

Key words: sulphonylurea, hypoglycemia, diabetes mellitus type 2

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Journal of the Bulgarian Society of Endocrinology

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