[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%).


CONCLUSIONS
Vildagliptin, added to a first-line OAD monotherapy, allows patients to reach target HbA1c without experiencing significant adverse events.
Instituto Jalisciense de Metabolismo, Guadalajara, México.
Eduardo
E
Márquez-Rodríguez
IMSS del Estado de México y Municipios, Toluca, México.
Eduardo
E
Brea-Andrea
Práctica Privada, México.
Victoria Alejandro
VA
Rajmet-Hace
Práctica Privada, México.
Javier
J
Salinas-Salinas
Novartis Pharma AG#, Ciudad de México, México.
Fabiola
F
Mariño-Rojas
D000218:Adamantane / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000284:Administration, Oral; D000328:Adult; D000368:Aged; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy*; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007003:Hypoglycemia / Q000139:chemically induced; D007004:Hypoglycemic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008800:Mexico; D008875:Middle Aged; D009570:Nitriles / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D011759:Pyrrolidines / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D000077597:Vildagliptin
D000218:Adamantane; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D009570:Nitriles; D011759:Pyrrolidines; D000077597:Vildagliptin