ESTIMATING THE LONG-TERM CLINICAL OUTCOMES ASSOCIATED WITH SWITCHING TO INSULIN ASPART (NOVORAPID®) FROM HUMAN SOLUBLE INSULIN IN TYPE 2 DIABETES PATIENTS IN THE POLISH SETTING

OBJECTIVES: The recent PREDICTIVE (Predictable Results and Experience in Diabetes through Intensification and Control to Target: an International Variability Evaluation) clinical trial demonstrated that switching type 2 diabetes patients on human soluble insulin (HSI) to insulin aspart (IAsp, NovoRapid) was associated with improvements in HbA1c and body weight. The aim of this study was to assess the long-term clinical implications of these benefits in type 2 diabetes patients in the Polish setting. METHODS: A previously published and validated computer simulation model of diabetes was used to project long-term clinical outcomes associated with these two treatments based on published data. Short-term treatment effects were taken from the PREDICTIVE study. Baseline cohort characteristics were based on PREDICTIVE and supplemented with published data considered to be representative of Polish type 2 diabetes patients. RESULTS: Treatment with IAsp was projected to increase undiscounted life expectancy by approximately 0.05 years compared to HSI (6.91±0.12 versus 6.86±0.12 years). Applying an annual discount rate of 5% decreased this benefit to 0.03 years (5.12±0.12 versus 5.09±0.12 years). Treatment with IAsp was projected to decrease the incidence of retinopathy, cardiovascular and renal complications compared to HSI. For example, the cumulative incidence (CI) of myocardial infarction was reduced by 4.5% with IAsp compared to HSI. Similarly, reductions in CI of proliferative diabetic retinopathy (17.6%), neuropathy (8.4%) and overt nephropathy (12.4%) were projected. The CI of end-stage renal disease, one of the costliest complications of diabetes, was reduced by 14.5% with IAsp compared to HSI. CONCLUSION: Over patient lifetimes, IAsp treatment was projected to result in fewer diabetes-related complications and improve life expectancy. In a population with a relatively high baseline prevalence of complications considered to be representative of Polish type 2 diabetes patients, IAsp-based therapy was projected to reduce the development of complications compared to HSI.