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ISSN 0016-3813 (Print)

2016, Number 4

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Gac Med Mex 2016; 152 (4)

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

Márquez-Rodríguez E, Brea-Andrea E, Rajmet-Hace VA, Salinas-Salinas J, Mariño-Rojas F

Language: Spanish
References: 21
Page: 457-464
PDF size: 712.16 Kb.


ABSTRACT

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.


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