Safety and effectiveness of linagliptin in Korean patients with type 2 diabetes: A postmarketing surveillance study

Abstract

We designed the post‐marketing surveillance study of linagliptin for patients with type 2 diabetes (T2D) in Korea. This prospective, observational, multicenter study investigated the safety and glycemic effectiveness of linagliptin as monotherapy or combination therapy with other antidiabetic drugs in routine clinical practice. Endpoints were the incidence of adverse drug reactions (ADRs) and the change of glycated hemoglobin (HbA1c). Overall, 3119 and 2171 patients were included in the safety and effectiveness analysis sets. A total of 56 patients (1.8%) experienced ADRs. The most common ADR was gastrointestinal disorders (0.7%), followed by metabolism and nutrition disorders (0.5%). ADRs of special interest, including pancreatic diseases, cardiac diseases, and hypoglycemia, occurred in 12 patients; 11 of them had hypoglycemia and one had skin lesion. Mean HbA1c change during study period was ‐0.8%. Lower body mass index, shorter diabetes duration and higher baseline HbA1c were independently associated with a better effectiveness, whereas the presence of diabetic complications, dyslipidemia, and usage of sulfonylurea were associated with a poor response. In conclusion, linagliptin showed an excellent safety profile and glycemic effectiveness in Korean patients with T2D.