The VERIFY study of primary treatment in type 2 diabetes mellitus (T2DM) , showed delayed glycemic failure (HbA1c ≥7.0% at two consecutive scheduled visits post randomization) with early combination of vildagliptin and metformin (EC) versus initial metformin monotherapy in patients with newly diagnosed T2DM (HbA1c 6.5%-7.5%) . Throughout the 5-year study, 57 adjudicated cardiovascular (CV) events were collected but the study was not powered to test the hypothesis that EC was also able to decrease CV events. Here we explore whether simple clinical data at T2DM onset (Framingham risk equation, CV disease history [CVD-Hx]) could identify patients at risk of subsequent CV events. At baseline, Framingham risk score (FRS) was 14.9±9.2% and 220 (12.3%) patients had CVD-Hx. A significant higher risk in patients with CVD-Hx and FRS ≥20% was visually apparent on KM curves and log rank-test (p=0.001; Figure) . Baseline HbA1c, age and gender were not significantly associated with the CV outcome, whereas treatment failure within the first 3 years was significantly associated with a higher risk of CV events (HR [95% CI]: 3.1 [1.7, 5.6]; p=0.0001) . These analyses suggests that both CV risk stratification at onset of T2DM and early loss of glycemic control may identify patients at higher risk of subsequent CV events.
D.R.Matthews: Advisory Panel; Novo Nordisk A/S, Other Relationship; Novartis AG, Speaker's Bureau; Servier Laboratories. S.Del prato: Advisory Panel; Applied Therapeutics, Eli Lilly and Company, Novartis Pharmaceuticals Corporation, Novo Nordisk A/S, Sanofi, Consultant; Menarini Group, Research Support; AstraZeneca, Boehringer Ingelheim International GmbH, Speaker's Bureau; AstraZeneca, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Merck & Co., Inc., Sanofi, Stock/Shareholder; Novo Nordisk A/S. P.M.Paldanius: Consultant; Glyconics Ltd, UPM Biomedicals, Speaker's Bureau; Novartis AG, UPM Biomedicals. G.Bader: Employee; Novartis AG.