Background and Aims: Type 2 diabetes (T2D) cardiovascular (CV) risk calculators focus mainly on those without CVD. We evaluated a T2D clinical outcomes simulation model (UKPDS Outcomes Model v2 [OM2]) estimates of CV risk in TECOS (Trial Evaluating Cardiovascular Outcomes with Sitagliptin) participants with T2D and CVD.
Materials and Methods: We compared estimated 3-year CV event and all-cause mortality (ACM) rates with observed rates. Covariates included: sex, ethnicity, age, diabetes duration, atrial fibrillation, albuminuria; baseline plus annual measures of smoking, HDL and LDL-cholesterol, weight, systolic blood pressure, HbA1c, heart rate, white cell count, haemoglobin, estimated glomerular filtration rate; and prior history of ischaemic heart disease, heart failure, amputation, blindness, kidney failure, stroke, myocardial infarction (MI) or diabetic foot ulcer.
Results: 1491/14671 (10.2%) participants experienced ≥1 major CV event over median 3.0 years follow-up. Predicted compared with observed rates were 6.4% vs. 5.1% for CV death, 7.7% vs. 4.2% ≥1 MI event and 3.5% vs. 2.5% for ≥1 stroke event (Table). Discrimination was fair (aROC>0.6) for stroke, CV death and ACM, but poor for MI. Simulated relative risks matched those observed.
Conclusion: OM2 overestimates absolute CV and ACM risk in TECOS participants, but correctly simulates the lack of sitagliptin impact.
R.L. Coleman: None. A.M. Gray: Advisory Panel; Self; Sanofi-Aventis. D.K. McGuire: Consultant; Self; Eisai Co., Ltd., Eli Lilly and Company, Pfizer Inc. Research Support; Self; Janssen Pharmaceuticals, Inc. Other Relationship; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Lexicon Pharmaceuticals, Inc., Merck Sharp & Dohme Corp., Novo Nordisk A/S, Sanofi-Aventis. R.R. Holman: Advisory Panel; Self; Bayer AG, Novartis AG, Novo Nordisk A/S. Research Support; Self; AstraZeneca, Bayer AG, Merck Sharp & Dohme Corp. Other Relationship; Self; AstraZeneca, Bayer AG, GlaxoSmithKline plc., Janssen Pharmaceuticals, Inc.