Key result
A prediction model estimated a median 10-year absolute risk reduction of 3.2% for major cardiovascular events with moderate-intensity statin therapy in patients with type 2 diabetes, with wide individual variation.
Why the study?
Does moderate-intensity statin therapy reduce the absolute risk of major cardiovascular events in individual patients with type 2 diabetes mellitus?
Observational (n=9,441)
Yes
Does moderate-intensity statin therapy reduce the absolute risk of major cardiovascular events in individual patients with type 2 diabetes mellitus?
Absolute Risk Reduction: 3.2 (95% CI -1.4–6.8)
Absolute Risk Reduction: 3.2%
Number Needed to Treat: 31
A prediction model based on routinely available characteristics can accurately estimate individualized 10-year absolute risk reductions for major cardiovascular events from moderate-intensity statin therapy in patients with type 2 diabetes, revealing a wide distribution of benefit that can guide shared decision-making.
May support individualized statin decisions in T2DM; leaves open need for prospective validation.
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. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00327418 (CARDS) and NCT00000542 (ALLHAT).
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Kaasenbrood et al. (2016) conducted an observational in Type 2 diabetes mellitus (n=9,441). Moderate-intensity statin therapy vs. Placebo or usual care was evaluated on 10-year individualized absolute risk reduction (ARR) of major cardiovascular events (Median ARR 3.2%, 95% CI -1.4 to 6.8). A prediction model estimated a median 10-year absolute risk reduction of 3.2% for major cardiovascular events with moderate-intensity statin therapy in patients with type 2 diabetes, with wide individual variation.
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