Efetividade e segurança de vildagliptina comparativamente com outros antidiabéticos orais em doentes com diabetes tipo 2: estudo EDGE em Portugal

Abstract

IntroductionType 2 diabetes mellitus (T2DM) is a progressive disease that usually requires intensification of therapy over time. Guidelines for treatment intensification are generally based on rigorous randomized controlled trials, and there is a need for real‐life studies, that better translate drugs’ behaviour in clinical practice. MethodsEDGE (Effectiveness of Diabetes control with vildaGliptin and vildagliptin/mEtformin) was an observational prospective study that compared the effectiveness and safety of add‐on vildagliptin and other oral antidiabetics (OAD) in 45,868 patients worldwide with T2DM inadequately controlled with monotherapy. ResultsSix thousand five hundred forty‐six patients, with a mean age of 63.5±11.0 years and 51.8% of males were included in Portugal. Baseline HbA1c was 7.9%±1.3 and 7.6%±1.2 in the vildagliptin (n=4,382) and comparator (n=2,164) groups, respectively. In the vildagliptin group, a greater proportion of patients achieved the primary endpoint of HbA1c reduction>0.3% without peripheral oedema, proven hypoglycaemic event, discontinuation due to a gastrointestinal event, or weight gain ≥5% (66.1% versus 54.4%, p<0.001). The adjusted HbA1c reduction was −1.1% and −0.9% in the vildaglitpin and comparator groups, respectively (p<0.001 for treatment difference). Adverse events were reported in 44 (1.0%) patients in the vildagliptin group and 23 (1.1%) patients in the comparator group. ConclusionsThe EDGE study showed that in real‐life clinical practice more patients treated with add‐on vildagliptin achieve significant HbA1c reductions without hypoglycaemia and weight gain, compared to other OAD associations.