1224-P: Validation of a New Diabetes Staging System (DSS) for Type 2 Diabetes (T2D) Using Data from Three Cardiovascular Outcomes Trials (CVOTs)

Abstract

More than 400 million people have T2D but an intuitive staging system like TNM used in oncology that predicts survival based on stage is lacking. DSS is designed to fill this void, facilitate communication and management and predict survival. DSS uses discrete CV events (none to ≥3: stage 1 to 4), end-stage renal disease (stage 5) and microvascular complications (none to ≥3: A to D) to stage T2D patients. It is hypothesized that higher DSS stage is associated with higher mortality. We used three large CVOTs (CAROLINA, n=6014, pooled linagliptin and glimepiride; CARMELINA, n=3792, pooled linagliptin and placebo; and the placebo group of EMPA-REG OUTCOME, n= 2300, with information available) that included patients with T2D with or without CVD and chronic kidney disease. By use of investigator reported baseline conditions, we categorized patients into DSS stages and calculated incidence rates (IR) for all-cause death. We observed a pattern of increasing IR for death with more advanced DSS stage, although with overlapping confidence intervals, with some variations between trials (Figure). A pattern of eGFR<60 ml/min/1.73m2 impacting in more advanced stages were observed across trials, whereas the pattern for HbA1c was less clear. Higher DSS stage appeared to be associated with increased mortality across all three CVOT trials but needs validation in the general T2D populations. Disclosure M. Dar: None. C. Wanner: Advisory Panel; Self; Eli Lilly and Company, Merck & Co., Inc., Mundipharma International. Consultant; Self; Boehringer Ingelheim (Canada) Ltd., Sanofi Genzyme. Speaker’s Bureau; Self; AstraZeneca. Other Relationship; Self; Boehringer Ingelheim International GmbH. N. Marx: Other Relationship; Self; Amgen, AstraZeneca, Bayer Vital, Boehringer Ingelheim International GmbH, Daiichi Sankyo, Kowa Research Institute, Inc., Medtronic, Merck Sharp & Dohme Corp., Novo Nordisk A/S, Pfizer Inc., Sanofi-Aventis. O. Johansen: Employee; Self; Boehringer Ingelheim International GmbH. A. Ofstad: Employee; Self; Boehringer Ingelheim International GmbH. M. Mattheus: None. S. Kaspers: Employee; Self; Boehringer Ingelheim International GmbH. J.T. George: Employee; Self; Boehringer Ingelheim International GmbH. J. Rosenstock: Research Support; Self; AstraZeneca, Bristol-Myers Squibb, Genentech, Inc., GlaxoSmithKline plc., Lexicon Pharmaceuticals, Inc., Oramed Pharmaceuticals, PegBio Co., Ltd., Pfizer Inc., REMD Biotherapeutics. Other Relationship; Self; Applied Therapeutics, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Intarcia Therapeutics, Janssen Pharmaceuticals, Inc., Novo Nordisk Inc., Sanofi. D.K. McGuire: Consultant; Self; Afimmune, Applied Therapeutics, Merck Sharp & Dohme Corp., Metavant. Other Relationship; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eisai Co., Ltd., Eli Lilly and Company, Esperion Therapeutics, Inc., GlaxoSmithKline plc., Janssen Pharmaceuticals, Inc., Lexicon Pharmaceuticals, Inc., Merck & Co., Inc., Novo Nordisk A/S, Pfizer Inc., Sanofi-Aventis. S.A. Beg: None.