OBJECTIVES

There is clinical evidence that having a hypoglycemic event increases the risk of cardiovascular disease and mortality. In version 9.5 of the IQVIA Core Diabetes Model (CDM), an association relative risk factor (RR) of developing Cardiovascular Disease (CVD) and CVD mortality events related to non-severe (NSHE) and severe (SHE) hypoglycemic events over an adjustable duration were included. CVD conditions are Myocardial Infarction (MI), Stroke, Congestive Heart Failure (CHF) and angina. The current study compared the model outcomes obtained with and without applying a variable RR.

METHODS

The observational EDGE study comparing metformin + vildagliptin (M+V) versus metformin + sulphonylurea (M+S) was used as a base case. Basal insulin rescue therapy was applied to both arms when an HbA1c level of 7.5% was reached. Mean age at study start was 57.8 years and duration of diabetes 6 years. NSHE and SHE rate were applied as 13.94 per 100 patient-years (100 pt/year), 2.46 (100 pt/year) for M+S and 1.785, 0.315 (100 pt/year) for M+V. A RR of 1.1 was applied for all CVD conditions over a five-year period. UK 2018 costs were applied; costs and health benefits were discounted at 3.5%.

RESULTS

Using RR increase of 1.1 for CVD and mortality due to SHE and NSHE, changed life expectancy (LE) and QALY with -1.68 and -1.55% (LY: from 11.961 to 11.760; QALY: 8.335 to 8.91) for M+V and -1.55 and -1.50% (LY: from 11.959 to 11.716; QALY: 8.217 to 8.052) for M+S. ICER decreased with -77% (66,336 to 15,086). Small increase in lifelong CVD event rates was seen.

CONCLUSIONS

The impact of applying RR on CVD and mortality can be considerable depending on the absolute hypoglycemia rates, and thus more in type 1 than in type 2 diabetes.