Safety and Tolerability of Vildagliptin 100 mg Sustained-Release Formulation in Type 2 Diabetes Mellitus: Results...

Management of type 2 diabetes mellitus (T2DM) often requires multiple medications and complex dosing schedules, which can compromise adherence, especially in those with multiple comorbidities. Strategies that reduce pill burden and dosing frequency may enhance patient convenience and compliance. Vildagliptin administered as a 100 mg sustained-release (SR) formulation once daily offers an alternative to the conventional 50 mg twice-daily regimen. This prospective post-marketing surveillance study evaluated the safety and tolerability of vildagliptin 100 mg SR over 24 weeks in patients with T2DM.

This was a prospective, multicenter, single-arm, open-label study. Adults (≥18 years) with a clinical diagnosis of T2DM were prescribed vildagliptin 100 mg sustained-release once daily. The incidence of adverse drug reactions (ADRs) and mean changes in glycated hemoglobin (HbA1c), fasting plasma glucose (FPG), postprandial glucose (PPG), alanine aminotransferase (ALT), aspartate aminotransferase (AST), serum creatinine, serum amylase, and serum lipase were evaluated at 12 and 24 weeks.

A total of 210 patients (129 males and 81 females) with a mean (SD) age of 52.63 (10.77) years were enrolled. A total of nine ADRs were reported in seven patients (3.3%), corresponding to an overall incidence of 4.3%. All events were mild in intensity, non-serious, and assessed as having a probable or likely relationship with the study drug. The mean HbA1c level decreased significantly from 7.89 at baseline to 7.27 at week 12 and 7.06 at week 24 (both p<0.001). Mean FPG levels at baseline, week 12, and week 24 were 145.92, 138.29, and 135.82 mg/dL, respectively, while the corresponding PPG levels were 201.84, 186.62, and 180.99 mg/dL, respectively. The p-values for the declines in both parameters at both time points were <0.001. There were no clinically meaningful changes (p>0.05) in AST and serum creatinine levels. The mean serum alanine aminotransferase (ALT) level decreased from 29.08 U/L to 27.76 U/L (p<0.05) at week 24. Similarly, mean serum amylase and lipase levels decreased from 59.36 U/L and 49.06 U/L to 56.50 U/L (p<0.05) and 45.38 U/L (p<0.01), respectively, at week 24.

This study demonstrated that vildagliptin 100 mg SR once daily monotherapy given over 24 weeks was well tolerated and effective in patients with T2DM. It effectively controlled glycemic parameters with no significant adverse events or harmful renal or hepatic effects.