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

Abstract

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.

Keywords:

• Dipeptidyl peptidase-4 inhibitor
• oral antidiabetes drugs
• real-world
• type 2 diabetes mellitus
• vildagliptin

Transparency

Declaration of funding

Novartis Pharma, Egypt has funded and provided oversight on the conduct of the study, including design, collection and compilation of data. The data was analyzed by CRO Jubilant Clinsys Limited, India.

Declaration of financial/other relationships

S.S. has disclosed that he has received investigator fees related to the conduct of this study from Novartis and its affiliates. S.R. has disclosed that he is an employee of Novartis Pharma SAE.

CMRO peer reviewers on this manuscript have no relevant financial relationships to disclose.

Acknowledgments

The authors gratefully acknowledge all the investigators, medical staff, and patients at the participating sites; they also thank Nashwa Nashaat (former employee of Novartis Pharma, Egypt) for her contribution in reviewing the study protocol. The authors wish to thank Shilpa Kakkar and Nihal Maremanda, Novartis Healthcare Pvt. Ltd., India for medical writing support.