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

Idioma: Español
Referencias bibliográficas: 21
Paginas: 457-464
Archivo PDF: 712.16 Kb.

RESUMEN

Antecedentes: El estudio multinacional EDGE (siglas derivadas de su nombre en inglés Effectiveness of Diabetes control with vildaGliptin and vildagliptin/mEtformin) evaluó la efectividad y la tolerabilidad de vildagliptina añadida a la monoterapia en pacientes que no lograron alcanzar metas de glicemia versus otros antidiabéticos orales (AO). Métodos: Estudio observacional, prospectivo de 1 año de tratamiento en condiciones de vida-real. El criterio primario de efectividad fue la reducción de HbA1c › 0.3% sin edema periférico, hipoglicemia, aumento de peso › 5% o descontinuación debido a eventos gastrointestinales (GI). El criterio secundario fue HbA1c ‹ 7% (a 12 meses) sin hipoglicemia comprobada o aumento de peso ≥ 3%. Resultados: De los 3,523 pacientes incluidos en México, 2,847 estuvieron en la cohorte vildagliptina y 676 en la de comparación. El criterio primario de efectividad fue alcanzado en el 61.8 y 53.2% en las cohortes vildagliptina y comparación, respectivamente. La razón de disparidad sin ajuste fue de 1.42 (IC 95%: 1.19-1.68) a favor de vildagliptina. Una ventaja similar se observó en el criterio secundario de efectividad. El porcentaje de eventos adversos (EA) fue menor en vildagliptina (n = 145; 5.0%) que en cohorte de comparación (n = 95; 14.0%). Conclusión: Vildagliptina añadida a otro AO permite alcanzar la meta de HbA1c sin experimentar EA significativos.

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