[Effectivity and security of vildagliptin as additional treatment for Type 2 diabetes mellitus in real-life conditions in Mexico. EDGE Study subanalysis].

Background: The multinational EDGE (Effectiveness of Diabetes control with vildaGliptin and vildagliptin/mEtformin) study assessed the effectiveness and tolerability of vildagliptin versus other oral antihyperglycemic drugs (OAD) when added to monotherapy in patients in the real-world setting.

Methods: Prospective, real-world observational study. The primary endpoint (PEP) was the proportion of patients achieving a reduction in HbA1c > 0.3% without peripheral edema, hypoglycemia, discontinuation, dueto gastrointestinal event, or weight gain > 5%. The secondary endpoint (SEP) was the proportion of patient achieving HbA1c < 7% (at month 12), without proven hypoglycemia or weight gain (≥ 3%).

Results: Of the 3,523 patients enrolled in Mexico, 2,847 were in the vildagliptin and 676 in the comparator cohort. The PEP was reached in 61.8 and 53.2% in the vildagliptin and comparator cohorts, respectively. The unadjusted odds ratio was 1.42 (95% CI: 1.19-1.68) in favor of vildagliptin. A similar advantage for vildagliptin-based therapies was seen for the SEP. The percentage was lower in the vildagliptin (n = 145; 5.0%) than in the comparator group (n = 95; 14.0%).

Conclusion: Vildagliptin, added to a first-line OAD monotherapy, allows patients to reach target HbA1c without experiencing significant adverse events.