The Real-Life Effectiveness and Care Patterns of Diabetes Management Study for Balkan Region (Slovenia, Croatia, Serbia, Bulgaria): A Multicenter, Observational, Cross-Sectional Study

Abstract

Introduction

Recent large randomized controlled trials highlighted the clinical significance of hypoglycemic episodes in the treatment of diabetes. The present survey was conducted to provide information from real-life practice on the incidence of hypoglycemia in type 2 diabetic patients treated with sulfonylureas.

Methods

This multicenter, observational, cross-sectional study collected data on incidence of side effects of sulfonylurea-based therapy in type 2 diabetic patients in four countries of the Balkan region (Slovenia, Croatia, Serbia, Bulgaria) from October 2014 to June 2015.

Results

Of the 608 who participated in the study, 573 patients (mean age 67.2 years, mean body mass index 29.9 kg/m ²) met the inclusion/exclusion criteria. More than 90% of the patients were treated with the newer generation sulfonylureas—gliclazide or glimepiride—either as monotherapy or as dual therapy in combination with metformin. In total, 210 patients (36.6%) reported hypoglycemic episode(s) in the last 6 months. Mild episodes were reported by 132 patients (62.8%), moderate by 66 (31.2%), severe by 8 patients (4.0%), and very severe by 4 patients (2%), respectively. Overall, 171 patients (28.2%) reported body weight increase during the previous year. The mean reported body weight gain in this group of patients was 4.2 kg (SD 2.7, median 3). Among them, 68.1% gained less than 5 kg, 25.0% gained 5–9 kg, and the rest gained more than 10 kg.

Conclusion

Although newer generation sulfonylureas are generally considered safe in terms of hypoglycemia, our data indicates their use is associated with substantial risk of hypoglycemia and weight gain. Clinicians should be mindful of these findings when prescribing SUs and inform patients about the risk of hypoglycemia.

Funding

Merck Sharp & Dohme.

Electronic supplementary material

The online version of this article (doi:10.1007/s13300-017-0288-x) contains supplementary material, which is available to authorized users.