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Development and Internal Validation of a Discrete Event Simulation Model of Diabetic Kidney Disease Using CREDENCE Trial Data

Willis M, Asseburg C, Slee A, Nilsson A, Neslusan C

We developed a simulation model that can be used to estimate the long-term health and economic consequences of DKD treatment interventions for patients with diabetic kidney disease.

The CREDENCE Economic Model of DKD (CREDEM-DKD) was developed using patient-level data from CREDENCE (which recruited patients with estimated glomerular filtration rate 30 to <?90 mL/min/1.73 m2, urinary albumin to creatinine ratio?>?300–5000 mg/g, and taking the maximum tolerated dose of a renin–angiotensin–aldosterone system inhibitor). Risk prediction equations were fit for start of maintenance dialysis, doubling of serum creatinine, hospitalization for heart failure, nonfatal myocardial infarction, nonfatal stroke, and all-cause mortality. A micro-simulation model was constructed using these risk equations combined with user-definable kidney transplant event risks.

Internal validation was performed by loading the model to replicate the CREDENCE study and comparing predictions with trial Kaplan–Meier estimate curves. External validation was performed by loading the model to replicate a subgroup of the CANagliflozin cardioVascular Assessment Study (CANVAS) Program with patient characteristics that would have qualified for inclusion in CREDENCE.

Risk prediction equations generally fit well and exhibited good concordance, especially for the placebo arm. The model performed well in internal and external validation exercises.

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Diabetes Therapy 2020;11(11):2657-2676
DOI: https://doi.org/10.1007/s13300-020-00923-w