{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,16]],"date-time":"2026-02-16T17:45:01Z","timestamp":1771263901545,"version":"3.50.1"},"reference-count":46,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"3","content-domain":{"domain":["www.ahajournals.org"],"crossmark-restriction":true},"short-container-title":["Circ: Cardiovascular Quality and Outcomes"],"published-print":{"date-parts":[[2016,5]]},"abstract":"<jats:sec>\n            <jats:title>Background\u2014<\/jats:title>\n            <jats:p>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.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Methods and Results\u2014<\/jats:title>\n            <jats:p>\n              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 &lt;2% for 13% of the patients. About 30% had an ARR of &gt;4% (median ARR, 3.2%; interquartile range, 2.5%\u20134.3%; 95% confidence interval for 3.2% ARR, \u20131.4% 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:\n              <jats:italic>c<\/jats:italic>\n              -statistics, 0.64 [95% confidence interval, 0.61\u20130.67] and CARDS: 0.68 [95% confidence interval, 0.64\u20130.72]).\n            <\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Conclusions\u2014<\/jats:title>\n            <jats:p>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.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Clinical Trial Registration\u2014<\/jats:title>\n            <jats:p>\n              URL:\n              <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/www.clinicaltrials.gov\">http:\/\/www.clinicaltrials.gov<\/jats:ext-link>\n              . Unique identifier: NCT00327418 (CARDS) and NCT00000542 (ALLHAT).\n            <\/jats:p>\n          <\/jats:sec>","DOI":"10.1161\/circoutcomes.115.001980","type":"journal-article","created":{"date-parts":[[2016,5,13]],"date-time":"2016-05-13T00:12:57Z","timestamp":1463098377000},"page":"213-221","update-policy":"https:\/\/doi.org\/10.1161\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":13,"title":["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"],"prefix":"10.1161","volume":"9","author":[{"given":"Lotte","family":"Kaasenbrood","sequence":"first","affiliation":[{"name":"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; ICCH, Imperial College London, London, United Kingdom (N.R.P., P.S.S.); Biomedical Research Institute, University of Dundee, Dundee, Scotland, United Kingdom (H.M.C., S.J.L.); Department of Cardiology, Academic Medical Centre, Amsterdam, The Netherlands (S.M.B.); and University of Texas Health Science Center, Houston..."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Neil R.","family":"Poulter","sequence":"additional","affiliation":[{"name":"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; ICCH, Imperial College London, London, United Kingdom (N.R.P., P.S.S.); Biomedical Research Institute, University of Dundee, Dundee, Scotland, United Kingdom (H.M.C., S.J.L.); Department of Cardiology, Academic Medical Centre, Amsterdam, The Netherlands (S.M.B.); and University of Texas Health Science Center, Houston..."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peter S.","family":"Sever","sequence":"additional","affiliation":[{"name":"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; ICCH, Imperial College London, London, United Kingdom (N.R.P., P.S.S.); Biomedical Research Institute, University of Dundee, Dundee, Scotland, United Kingdom (H.M.C., S.J.L.); Department of Cardiology, Academic Medical Centre, Amsterdam, The Netherlands (S.M.B.); and University of Texas Health Science Center, Houston..."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Helen M.","family":"Colhoun","sequence":"additional","affiliation":[{"name":"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; ICCH, Imperial College London, London, United Kingdom (N.R.P., P.S.S.); Biomedical Research Institute, University of Dundee, Dundee, Scotland, United Kingdom (H.M.C., S.J.L.); Department of Cardiology, Academic Medical Centre, Amsterdam, The Netherlands (S.M.B.); and University of Texas Health Science Center, Houston..."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shona J.","family":"Livingstone","sequence":"additional","affiliation":[{"name":"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; ICCH, Imperial College London, London, United Kingdom (N.R.P., P.S.S.); Biomedical Research Institute, University of Dundee, Dundee, Scotland, United Kingdom (H.M.C., S.J.L.); Department of Cardiology, Academic Medical Centre, Amsterdam, The Netherlands (S.M.B.); and University of Texas Health Science Center, Houston..."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"S. Matthijs","family":"Boekholdt","sequence":"additional","affiliation":[{"name":"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; ICCH, Imperial College London, London, United Kingdom (N.R.P., P.S.S.); Biomedical Research Institute, University of Dundee, Dundee, Scotland, United Kingdom (H.M.C., S.J.L.); Department of Cardiology, Academic Medical Centre, Amsterdam, The Netherlands (S.M.B.); and University of Texas Health Science Center, Houston..."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sara L.","family":"Pressel","sequence":"additional","affiliation":[{"name":"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; ICCH, Imperial College London, London, United Kingdom (N.R.P., P.S.S.); Biomedical Research Institute, University of Dundee, Dundee, Scotland, United Kingdom (H.M.C., S.J.L.); Department of Cardiology, Academic Medical Centre, Amsterdam, The Netherlands (S.M.B.); and University of Texas Health Science Center, Houston..."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Barry R.","family":"Davis","sequence":"additional","affiliation":[{"name":"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; ICCH, Imperial College London, London, United Kingdom (N.R.P., P.S.S.); Biomedical Research Institute, University of Dundee, Dundee, Scotland, United Kingdom (H.M.C., S.J.L.); Department of Cardiology, Academic Medical Centre, Amsterdam, The Netherlands (S.M.B.); and University of Texas Health Science Center, Houston..."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yolanda","family":"van der Graaf","sequence":"additional","affiliation":[{"name":"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; ICCH, Imperial College London, London, United Kingdom (N.R.P., P.S.S.); Biomedical Research Institute, University of Dundee, Dundee, Scotland, United Kingdom (H.M.C., S.J.L.); Department of Cardiology, Academic Medical Centre, Amsterdam, The Netherlands (S.M.B.); and University of Texas Health Science Center, Houston..."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Frank L.J.","family":"Visseren","sequence":"additional","affiliation":[{"name":"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; ICCH, Imperial College London, London, United Kingdom (N.R.P., P.S.S.); Biomedical Research Institute, University of Dundee, Dundee, Scotland, United Kingdom (H.M.C., S.J.L.); Department of Cardiology, Academic Medical Centre, Amsterdam, The Netherlands (S.M.B.); and University of Texas Health Science Center, Houston..."}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"276","reference":[{"key":"e_1_3_3_2_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(08)60104-X"},{"key":"e_1_3_3_3_2","doi-asserted-by":"publisher","DOI":"10.1093\/eurheartj\/ehs092"},{"key":"e_1_3_3_4_2","first-page":"3024","article-title":"2013 ACC\/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults: A Report of the American College of Cardiology\/American Heart Association Task Force on Practice Guidelines","volume":"63","author":"Stone NJ","year":"2013","unstructured":"Stone NJ, Robinson J, Lichtenstein AH, Bairey Merz CN, Lloyd-Jones DM, Blum CB, McBride P, Eckel RH, Schwartz JS, Goldberg AC, Shero ST, Gordon D, Smith SC, Levy D, Watson K, Wilson PW. 2013 ACC\/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults: A Report of the American College of Cardiology\/American Heart Association Task Force on Practice Guidelines. 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