Effectiveness and safety of vildagliptin and vildagliptin add-on to metformin in real-world settings in Egypt–results from the GUARD study

Objective: The GUARD study evaluated the effectiveness, safety, and tolerability of vildagliptin treatment with or without metformin in patients with type 2 diabetes mellitus (T2DM) in real-life settings. Here we present the results of the GUARD study for the patient subset from Egypt. Research design and methods: This was a 24 ± 6 weeks, prospective, non-interventional study that enrolled adult patients with T2DM receiving vildagliptin or vildagliptin + metformin combination therapy as per local prescribing information. Main outcome measures: The primary effectiveness endpoint was change in HbA1c levels from baseline to week 24 ± 6 endpoint. Safety was assessed by reporting of adverse events and serious adverse events (SAEs). Results: Of 2786 patients enrolled from Egypt, 655 received vildagliptin and 2131 received vildagliptin + metformin. Overall, at baseline, mean (± standard deviation [SD]) age was 49.5 ± 9.49 years, BMI was 31.5 ± 4.85 kg/m2, HbA1c was 8.4 ± 0.86%, and duration of T2DM was 2.3 ± 3.78 years. At week 24, significant reductions in mean (±SD) HbA1c were observed in the vildagliptin (−1.47 ± 0.79%) and vildagliptin + metformin (−1.62 ± 0.82%) groups (both p < 0.0001) from baseline HbA1c of 8.1% and 8.4%, respectively. At week 24, 67.5% patients in the vildagliptin group and 60.5% in the vildagliptin + metformin group achieved HbA1c ≤7.0%. Treatment with vildagliptin (± metformin) was well tolerated, with a low incidence of hypoglycemia in both groups (vildagliptin, 0.5%; vildagliptin + metformin, 0.6%). No SAEs or deaths were reported in the vildagliptin group; however, 0.2% of patients experienced SAEs and one death (accidental death) was reported in the vildagliptin + metformin group. Conclusion: In a real-world setting, vildagliptin, with or without metformin, resulted in significant reductions in HbA1c and was well tolerated in patients with T2DM from Egypt. Limitations of the study include non-randomization and the open-label, observational nature of the study.