Journal
CIRCULATION-CARDIOVASCULAR QUALITY AND OUTCOMES
Volume 9, Issue 3, Pages 213-+Publisher
LIPPINCOTT WILLIAMS & WILKINS
DOI: 10.1161/CIRCOUTCOMES.115.001980
Keywords
cardiovascular diseases; decision making, shared; diabetes mellitus; precision medicine; statins, HMG-CoA; treatment outcome
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Funding
- Stichting Wellerdieck-de Goede Fonds, the Netherlands [12.095]
- ZonMw, the Netherlands Organization for Health Research and Development [836011027]
- Pfizer
- Servier Research Group (Paris, France)
- Leo Laboratories (Copenhagen, Denmark)
- Solvay Pharmaceuticals (Brussels, Belgium)
- Diabetes UK
- UK Department of Health
- Pfizer UK
- Pfizer Inc
- National Heart, Lung, and Blood Institute [NO1-HC-35130]
- National Institute for Health Research [NF-SI-0513-10059] Funding Source: researchfish
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Background-In this study, we aimed to translate the average relative effect of statin therapy from trial data to the individual patient with type 2 diabetes mellitus by developing and validating a model to predict individualized absolute risk reductions (ARR) of cardiovascular events. Methods and Results-Data of 2725 patients with type 2 diabetes mellitus from the Lipid Lowering Arm of the Anglo Scandinavian Cardiac Outcomes Trial (ASCOT-LLA) study (atorvastatin 10 mg versus placebo) were used for model derivation. The model was based on 8 clinical predictors including treatment allocation (statin/placebo). Ten-year individualized ARR on major cardiovascular events by statin therapy were calculated for each patient by subtracting the estimated on-treatment risk from the estimated off-treatment risk. Predicted 10-year ARR by statin therapy was <2% for 13% of the patients. About 30% had an ARR of >4% (median ARR, 3.2%; interquartile range, 2.5%-4.3%; 95% confidence interval for 3.2% ARR, -1.4% to 6.8%). Addition of treatment interactions did not improve model performance. Therefore, the wide distribution in ARR was a consequence of the underlying distribution in cardiovascular risk enrolled in these trials. External validation of the model was performed in data from the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT-LLT; pravastatin 40 mg versus usual care) and Collaborative Atorvastatin Diabetes Study (CARDS; atorvastatin 10 mg versus placebo) of 3878 and 2838 patients with type 2 diabetes mellitus, respectively. Model calibration was adequate in both external data sets, discrimination was moderate (ALLHAT-LLT: c-statistics, 0.64 [95% confidence interval, 0.61-0.67] and CARDS: 0.68 [95% confidence interval, 0.64-0.72]). Conclusions-ARRs of major cardiovascular events by statin therapy can be accurately estimated for individual patients with type 2 diabetes mellitus using a model based on routinely available patient characteristics. There is a wide distribution in ARR that may complement informed decision making.
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