| Author |
Kaasenbrood, Lotte Poulter, Neil R. Sever, Peter S. Colhoun, Helen M. Livingstone, Shona J. Boekholdt, S. Matthijs Pressel, Sara L. Davis, Barry R. Van Der Graaf, Yolanda Visseren, Frank L. J. |
| Description |
Author Affiliation: Kaasenbrood L ( From the Department of Vascular Medicine (L.K., F.L.J.V.) and Julius Centre for Health Sciences and Primary Care (Y.v.d.G.), University Medical Centre Utrecht, Utrecht, The Netherlands); Poulter NR ( From the Department of Vascular Medicine (L.K., F.L.J.V.) and Julius Centre for Health Sciences and Primary Care (Y.v.d.G.), University Medical Centre Utrecht, Utrecht, The Netherlands); Sever PS ( From the Department of Vascular Medicine (L.K., F.L.J.V.) and Julius Centre for Health Sciences and Primary Care (Y.v.d.G.), University Medical Centre Utrecht, Utrecht, The Netherlands); Colhoun HM ( From the Department of Vascular Medicine (L.K., F.L.J.V.) and Julius Centre for Health Sciences and Primary Care (Y.v.d.G.), University Medical Centre Utrecht, Utrecht, The Netherlands); Livingstone SJ ( From the Department of Vascular Medicine (L.K., F.L.J.V.) and Julius Centre for Health Sciences and Primary Care (Y.v.d.G.), University Medical Centre Utrecht, Utrecht, The Netherlands); Boekholdt SM ( From the Department of Vascular Medicine (L.K., F.L.J.V.) and Julius Centre for Health Sciences and Primary Care (Y.v.d.G.), University Medical Centre Utrecht, Utrecht, The Netherlands); Pressel SL ( From the Department of Vascular Medicine (L.K., F.L.J.V.) and Julius Centre for Health Sciences and Primary Care (Y.v.d.G.), University Medical Centre Utrecht, Utrecht, The Netherlands); Davis BR ( From the Department of Vascular Medicine (L.K., F.L.J.V.) and Julius Centre for Health Sciences and Primary Care (Y.v.d.G.), University Medical Centre Utrecht, Utrecht, The Netherlands); van der Graaf Y ( From the Department of Vascular Medicine (L.K., F.L.J.V.) and Julius Centre for Health Sciences and Primary Care (Y.v.d.G.), University Medical Centre Utrecht, Utrecht, The Netherlands); Visseren FL ( From the Department of Vascular Medicine (L.K., F.L.J.V.) and Julius Centre for Health Sciences and Primary Care (Y.v.d.G.), University Medical Centre Utrecht, Utrecht, The Netherlands) |
| 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 <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). |
