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Table 1 Overview of 47 landmark prospective clinical trials with CV outcomes having included a substantial number and/or proportion of diabetic patients at baseline

From: Baseline diabetes as a way to predict CV outcomes in a lipid-modifying trial: a meta-analysis of 330,376 patients from 47 landmark studies

  CV prevention Patients Diabetes Active arm Comparator arm Follow-up Publication year Reference
   n n % n n years   
4D PP-SP 1255 1255 100 619 636 4.0 2005 [11]
4S SP 4444 202 5 2221 2223 5.4 1994 [1214]
 diabetes substudy SP 202 202 100 105 97 5.4 1997 [14]
ACCORD-Lipid PP-SP 5518 5518 100 2765 2753 4.7 2010 [15, 16]
ADDITION-Europe PP-SP 3055 3055 100 1678 1377 5.3 2011 [17, 18]
AFCAPS/TexCAPS PP 6605 155 2 3304 3301 5.2 1998 [19, 20]
AIM-HIGH SP 3414 1158 34 1718 1696 3.0 2011 [21, 22]
AleCardio SP 7226 7226 100 3616 3610 2.0 2014 [23, 24]
ALERT PP-SP 2102 396 19 1050 1052 5.1 2003 [25]
ALLHAT-LLT PP-SP 10355 3638 35 5170 5185 4.8 2002 [26]
Alpha-Omega SP 4837 1754 36 2404 2433 3.4 2010 [27]
ASCOT-LLA PP 10305 2532 25 5168 5137 3.3 2003 [28, 29]
 diabetes substudy PP 2532 2532 100 1258 1274 3.3 2005 [29]
ASPEN PP 2410 2410 100 1211 1199 4.0 2006 [30]
AURORA PP-SP 2773 731 26 1389 1384 3.8 2009 [31, 32]
 diabetes substudy PP-SP 731 731 100 388 343 2.8 2011 [32]
BIP SP 3090 309 10 1548 1542 6.2 2000 [33, 34]
CARDS PP 2838 2838 100 1428 1410 3.9 2004 [35]
CARE SP 4159 586 14 2081 2078 5.0 1998 [3638]
 diabetes substudy SP 586 586 100 282 304 5.0 1998 [38]
CDP (clofibrate) SP 3892 1517 39 1103 2789 6.2 1975 [39, 40]
CDP (niacin) SP 3908 1524 39 1119 2789 6.2 1975 [39, 40]
dal-OUTCOMES SP 15871 3882 24 7938 7933 2.6 2012 [41, 42]
DIS PP 761 761 100 379 382 5.0 1991 [43]
FIELD PP-SP 9795 9795 100 4895 4900 5.0 2005 [4446]
GISSI-Prevenzione SP 4271 582 14 2138 2133 2.0 2000 [47]
GREACE SP 1600 313 20 880 720 3.0 2002 [48, 49]
 diabetes substudy SP 313 313 100 161 152 3.0 2003 [49]
HATS SP 107 17 16 73 34 3.0 2001 [50]
HHS PP 4081 108 3 2051 2030 5.0 1987 [51, 52]
 diabetes substudy PP 135 135 100 59 76 5.0 1992 [52]
HPS - MRC/BHF PP-SP 20536 5963 29 10269 10267 5.0 2002 [53, 54]
 diabetes substudy PP-SP 5963 5963 100 2978 2985 4.8 2003 [54]
HPS2-THRIVE SP 25673 8299 32 12838 12835 3.9 2013 [55]
IDEAL SP 8888 1057 12 4439 4449 4.8 2005 [56, 57]
ILLUMINATE PP-SP 15067 6661 44.2 7533 7534 1.0 2007 [58]
JELIS PP-SP 18645 3040 16.3 9326 9319 4.6 2007 [59]
LEADER PP-SP 1568 268 17 783 785 4.6 2002 [60, 61]
LIPID SP 9014 782 9 4512 4502 6.1 1998 [6264]
LIPS SP 1677 202 12 844 833 3.9 2002 [65]
MEGA PP 7832 1632 21 3866 3966 5.3 2006 [66]
ORIGIN PP-SP 12536 11081 88.4 6281 6255 6.2 2012 [67]
PERFORM SP 19120 5299 27.7 9562 9558 2.4 2011 [68]
Post-CABG SP 1351 116 9 676 675 7.5 2000 [69, 70]
PREDIMED PP 7447 3614 49 4997 2450 4.5 2013 [71]
PROACTIVE SP 5238 5238 100 2605 2633 2.9 2005 [72, 73]
PROFIT-J PP-SP 481 481 100 234 247 1.8 2014 [74]
PROSPER PP-SP 5804 623 11 2891 2913 3.2 2002 [75]
RPS PP-SP 12505 7494 60 6239 6266 5.0 2013 [76, 77]
SHARP PP-SP 9270 2094 23 4650 4620 4.9 2011 [78]
STABILITY SP 15828 5351 34 7924 7904 3.7 2014 [79, 80]
STENO-2 PP-SP 160 160 100 80 80 13.3 2008 [81]
TNT SP 10001 1501 15 4995 5006 4.9 2005 [8286]
 diabetes substudy SP 1501 1501 100 753 748 4.9 2006 [86]
VA Cooperative Study SP 532 128 24 268 264 1.8 1973 [87]
VA-HIT SP 2531 769 30 1264 1267 5.1 1999 [8890]
 diabetes substudy SP 769 769 100 377 392 5.1 2002 [90]
Total (n)   330376 124115   165022 165354    
Mean        4.4   
  1. CV: cardiovascular; PP and SP: primary and secondary prevention. Acronyms: 4D: Die Deutsche Diabetes Dialyse studie; 4S: Scandinavian Simvastatin Survival Study; ACCORD-Lipid: Action to Control Cardiovascular Risk in Diabetes - Lipid arm; ADDITION-Europe: Anglo-Danish-Dutch Study of Intensive Treatment in People with Screen Detected Diabetes in Primary Care; AFCAPS/TexCAPS: Air Force/Texas Coronary Atherosclerosis Prevention Study; AIM-HIGH: Atherothrombosis Intervention in Metabolic Syndrome with Low HDL/High Triglycerides: Impact on Global Health Outcomes; AleCardio: A Safety and Efficacy Study to Evaluate the Potential of Aleglitazar to Reduce CV Risk in CHD Patients with a Recent ACS and T2DM; ALERT: Assessment of Lescol in Renal Transplantation; ALLHAT-LLT: Antihypertensive and Lipid-Lowering treatment to prevent Heart Attack Trial; ASCOT-LLA: Anglo-Scandinavian Cardiac Outcomes Trial - Lipid Lowering Arm; ASPEN: Atorvastatin as Prevention of CHD Endpoints in patients with Non-insulin dependent diabetes mellitus; AURORA: A Study to Evaluate the Use of Rosuvastatin in Subjects on Regular Hemodialysis: an Assessment of Survival and Cardiovascular Events; BIP: Bezafibrate Infarction Prevention; CARDS: Collaborative Atorvastatin Diabetes Study; CARE : Cholesterol and Recurrent Events; CDP: Coronary Drug Project; dal-OUTCOMES: Efficacy and safety of dalcetrapib in patients with recent acute coronary syndrome; DIS: Diabetes Intervention Study; FIELD: Fenofibrate Intervention and Event Lowering in Diabetes; GISSI-Prevenzione: Gruppo Italiano per lo Studio della Sopravvivenza nell’Infarto miocardico - Prevenzione; GREACE: Greek Atorvastatin and Coronary-heart-disease Evaluation; HATS: HDL-Atherosclerosis Treatment Study; HHS: Helsinki Heart Study; HPS - MRC/BHF: Medical Research Council and British Heart Foundation Heart Protection Study; HPS2-THRIVE: Heart Protection Study - Treatment of HDL to Reduce the Incidence of Vascular Events; IDEAL: Incremental Decrease in End Points Through Aggressive Lipid Lowering Trial; ILLUMINATE: Investigation of Lipid Level Management to Understand its Impact in Atherosclerosis Events; JELIS: Japan EPA Lipid Intervention Study; LEADER: Lower Extremity Arterial Disease Event Reduction; LIPID: Long-term Intervention with Pravastatin in Ischaemic Disease; LIPS: Lescol Intervention Prevention Study; MEGA: Primary Prevention of Cardiovascular Disease with Pravastatin in Japan; ORIGIN: Outcome Reduction with an Initial Glarigine Intervention; PERFORM: Prevention of cerebrovascular and cardiovascular Events of ischaemic origin with teRutroban in patients with a history oF ischaemic strOke or tRansient ischaeMic attack; Post-CABG (FU): Post Coronary Artery Bypass Graft Trial (follow-up); PREDIMED: Prevencion con Dieta Mediterranea; PROACTIVE: PROspective pioglitAzone Clinical Trial In macroVascular Events; PROFIT-J: PRimary preventiOn oF hIgh risk Type 2 diabetes in Japan; PROSPER: Prospective Study of Pravastatin in the Elderly at Risk; RPS: Risk and Prevention Study; SHARP: Study of Heart and Renal Protection; STABILITY: STabilization of Atherosclerotic plaque By Initiation of darapLadIb TherapY; STENO-2: STENO-2 Study; TNT: Treating to New Targets; VA Cooperative Study: Veteran Administration Cooperative Study of Atherosclerosis, Neurology Section; VA-HIT: Veterans Affairs High-Density Lipoprotein Intervention Trial