Background and aims: Proper assessment of long-term safety of newer antidiabetic agents (ADAs) is of prime importance as diabetes is a chronic disease requiring life-long management. The purpose of this analysis was to assess the safety of vildagliptin as monotherapy or as an add-on therapy to already existing ADAs (vildagliptin group) compared to non-vildagliptin group.
Materials and methods: Nine hundred and eighty-three patients in vildagliptin group and 1013 patients in non-vildagliptin group were included in the study drawn from the diabetes clinics. The dose of vildagliptin was either 50 or 100 mg/day, either as monotherapy or as an add-on therapy. Safety data included evaluation of clinical and laboratory adverse experiences (AEs).
Results: The incidence of drug-related AEs overall and discontinuations were higher in non-vildagliptin group, primarily due to hypoglycemia in SUs and basal insulin-treated, and due to GI side effects, especially due to AGIs. For specific AEs reported more frequently in the vildagliptin group (with 95% CI), 4 AEs were higher in the vildagliptin group (generalized itching, non-specific bullous rash, small joint pain and dysguesia) and 6 were higher in ADAs group (nausea, diarrhea, fatigue, headache, dizziness, and weight gain). There was no increased incidence of any infections, including urinary tract infections in vildagliptin group compared to other ADAs, slight but non-specific elevation of hepatic transaminases with vildagliptin monotherapy/add-on therapy, which resolved spontaneously.
Conclusion: Patients with type 2 diabetes tolerated vildagliptin as a monotherapy or as an add-on therapy for nearly 2 years without any increased incidence of significant side effects.