Validation of the CORE Diabetes Model against epidemiological and clinical studies.
ABSTRACT The aim of this study was to assess the validity of the CORE Diabetes Model by comparing results from model simulations with observed outcomes from published epidemiological and clinical studies in type 1 and type 2 diabetes.
A total of 66 second- (internal) and third- (external) order validation analyses were performed across a range of complications and outcomes simulated by the CORE Diabetes Model (amputation, cataract, hypoglycaemia, ketoacidosis, macular oedema, myocardial infarction, nephropathy, neuropathy, retinopathy, stroke and mortality). Published studies were reproduced in the model by recreating cohorts in terms of demographics, baseline risk factors and complications, treatment patterns and patient management strategies, and simulating the progress of the cohort to an equivalent time horizon.
Correlation analysis on results from 66 validation simulations produced an R2 value of 0.9224 (perfect fit = 1). A correlation plot of published study data versus values simulated by the CORE Diabetes Model had a trend line with a gradient of 1.0187 (perfect fit = 1). Validation analyses in type 1 and type 2 diabetes were associated with R2 values of 0.9778 and 0.8861 respectively. Correlation of second-order validation analyses (model predictions versus observed outcomes in studies used to construct the model) produced an R2 value of 0.9574, and the value for third-order analyses (model predictions versus observed outcomes in studies not used to construct the model) was 0.9023.
The CORE Diabetes Model provides an accurate representation of patient outcomes when compared to 66 studies of diabetes and its complications. Model flexibility ensures it can be used to compare diabetes management strategies in different cohorts across a variety of clinical settings.
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ABSTRACT: Abstract Objective: The objective of this analysis was to estimate the cost-effectiveness of exenatide once weekly (EQW) for the treatment of type two diabetes mellitus (T2DM) in Spain. EQW was compared against exenatide twice daily (EBID) and insulin glargine (IG). Methods: The IMS CORE Diabetes Model was used to project clinical and economic outcomes for patients with T2DM treated with EQW, EBID and IG. Treatment effects and patient baseline characteristics were taken from the DURATION 3 and pooled DURATION 1 and 5 studies, in the comparison against IG and EBID respectively. Unit costs and health state utility values were derived from published sources. To reflect diabetes progression, patients started on EQW or EBID, switching to insulin glargine after three years. The analysis was conducted from the perspective of the Spanish National Health Service over a time horizon of 35 years with costs and outcomes discounted at 3%. The base case included patients with a BMI>30kg/m2 which is in line with current prescription restrictions in Spain. Uncertainty was addressed through extensive one way sensitivity analyses around key model parameters and a comprehensive probabilistic sensitivity analysis. Results: When compared with EBID, EQW was the dominant strategy, i.e. less costly and more effective. When compared to IG, the incremental cost-effectiveness ratio was estimated at € 12,084 per QALY gained. Sensitivity analysis indicated that the model projections were robust to the various scenarios tested. Limitations: Primary limitations of the analysis are common to other T2DM analyses and include the extrapolation of short-term clinical data to the 35 year time horizon and uncertainty around optimum treatment durations. Conclusion: The analyses indicate that EQW is a cost-effective option for the treatment of T2DM patients in Spain for patients with a BMI>30kg/m2 considering a willingness-to-pay threshold of € 30,000 per QALY gained.Journal of Medical Economics 05/2013;
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ABSTRACT: Treatment with glucagon-like peptide-1 receptor agonists and dipeptidyl peptidase-4 inhibitors, which target the incretin axis, has the potential to improve glycemic control in type 2 diabetes patients without the weight gain associated with traditional therapies. To evaluate the relative cost-effectiveness of incretin therapies, the present study aimed to compare the long-term clinical and cost implications associated with liraglutide and sitagliptin in type 2 diabetes patients in Spain. Data were taken from a randomized, controlled trial (NCT00700817) in which adults with type 2 diabetes failing metformin monotherapy were randomly allocated to receive either liraglutide 1.2 mg or sitagliptin 100 mg daily in addition to metformin. Long-term projections of clinical outcomes and direct costs (2012 EUR) based on observed treatment effects were made using a published and validated type 2 diabetes model. Costs were taken from published sources. Future costs and clinical benefits were discounted at 3% annually. Sensitivity analyses were performed. Liraglutide was associated with improved discounted life expectancy (14.05 versus 13.91 years) and quality-adjusted life expectancy [9.04 versus 8.87 quality-adjusted life years (QALYs)] compared to sitagliptin. Improved clinical outcomes were driven by improved glycemic control, leading to reduced incidence of diabetes-related complications, including renal disease, cardiovascular disease, ophthalmic and diabetic foot complications. Liraglutide was associated with increased direct costs of EUR 2,297, yielding an incremental cost-effectiveness ratio of EUR 13,266 per QALY gained versus sitagliptin. Liraglutide was projected to improve life expectancy, quality-adjusted life expectancy and reduce incidence of diabetes-related complication. Liraglutide is likely to be cost-effective versus sitagliptin from a healthcare payer perspective in Spain.Diabetes therapy : research, treatment and education of diabetes and related disorders. 10/2013;
- Journal of diabetes and its complications 03/2013; · 2.11 Impact Factor