Development and validation of a model to predict absolute vascular risk reduction by moderate-intensity statin therapy in individual patients with type 2 diabetes mellitus

Lotte Kaasenbrood, Neil R. Poulter, Peter S. Sever, Helen M. Colhoun, Shona J. Livingstone, S. Matthijs Boekholdt, Sara L. Pressel, Barry R. Davis, Yolanda Van Der Graaf, Frank L J Visseren (Lead / Corresponding author)

    Research output: Contribution to journalArticle

    6 Citations (Scopus)

    Abstract

    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 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.

    Clinical Trial Registration - URL: http://www.clinicaltrials.gov. Unique identifier: NCT00327418 (CARDS) and NCT00000542 (ALLHAT).

    Original languageEnglish
    Pages (from-to)213-221
    Number of pages9
    JournalCirculation: Cardiovascular Quality and Outcomes
    Volume9
    Issue number3
    Early online date11 May 2016
    DOIs
    Publication statusPublished - May 2016

    Keywords

    • cardiovascular diseases
    • decision making shared
    • diabetes mellitus
    • precision medicine
    • statins HMG-CoA
    • treatment outcome

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