Effectiveness and tolerability of second-line therapy with vildagliptin vs. other oral agents in type 2 diabetes: a real-life worldwide observational study (EDGE).
Bottom Line: The adjusted odds ratio was 1.96 (95% CI: 1.85, 2.07; p < 0.001).Safety events were reported infrequently and safety profiles of vildagliptin and other OADs were consistent with previous data.In addition, EDGE illustrates that conducting large-scale, prospective, real-life studies poses challenges but yields valuable clinical information complementary to RCTs.
Affiliation: I.G. - Endocrinologie, Campus Gasthuisberg, Leuven, Belgium.Show MeSH
Related in: MedlinePlus
Mentions: Figure1 illustrates HbA1c time course in both cohorts, with final HbA1c changes at 12 months of −1.19% (95% CI: −1.21%, −1.18%) in vildagliptin-treated patients and −0.99% (95% CI: −1.01%, −0.97%) in comparator-treated patients (analysis not prespecified in protocol). Baseline body weight (mean ± SEM) was 81.4 ± 0.5 kg in the vildagliptin cohort and 77.9 ± 0.1 kg in the comparator cohort. The change from BL to end-point in body weight was −1.6 ± 0.03 kg with vildagliptin, and −0.3 ± 0.03 kg with comparator.
Affiliation: I.G. - Endocrinologie, Campus Gasthuisberg, Leuven, Belgium.