التفاصيل البيبلوغرافية
| العنوان: |
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: The Anglo Scandinavian Cardiac Outcomes Trial, Antihypertensive and... |
| المؤلفون: |
Kaasenbrood, Lotte, Poulter, Neil R., Sci, F Med, 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., CARDS, ALLHAT, and ASCOT Investigators |
| المصدر: |
Circulation: Cardiovascular Quality & Outcomes; May2016, Vol. 9 Issue 3, p213-221, 9p |
| مصطلحات موضوعية: |
DRUG therapy for hyperlipidemia, MYOCARDIAL infarction diagnosis, TYPE 2 diabetes diagnosis, TYPE 2 diabetes complications, ANTILIPEMIC agents, BLOOD pressure, COMPARATIVE studies, DECISION making, HYPERLIPIDEMIA, HYPERTENSION, ANTIHYPERTENSIVE agents, LIPIDS, RESEARCH methodology, MEDICAL cooperation, MYOCARDIAL infarction, PROBABILITY theory, RESEARCH, RESEARCH evaluation, RISK assessment, TIME, EVALUATION research, TREATMENT effectiveness, PREDICTIVE tests, DISEASE complications, DIAGNOSIS, PREVENTION |
| مصطلحات جغرافية: |
NORTH America, SCANDINAVIA |
| مستخلص: |
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.govTest. Unique identifier: NCT00327418 (CARDS) and NCT00000542 (ALLHAT). [ABSTRACT FROM AUTHOR] |
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