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Table 4 Primary CV outcome rates in the active (treatment) and control (comparator/placebo) arms

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

Study§ Intervention Primary; secondary CV outcomes§§ Events (n) treatment Events (%) treatment Rate (%.year-1) treatment Events (n) control Events (%) control Rate (%.year-1) control HR 95 % CI for HR P
4D statin C; D + J 226 36.5 9.13 243 38.2 9.55 0.96 0.77-1.1 0.37
4S statin A 182 8.2 1.52 256 11.5 2.13 0.71 0.58-0.85 0.0003
 diabetes substudy statin A 15 14.3 2.65 24 24.7 4.58 0.58 NR 0.087
ACCORD-Lipid fibrate C; J + D 291 10.5 2.24 310 11.3 2.40 0.93 0.79-1.08 0.32
ADDITION-Europe statin/other B; D + J + M + Z 121 7.2 1.36 117 8.5 1.60 0.85 0.65-1.05 0.12
AFCAPS/TexCAPS statin C; E 116 3.5 0.68 183 5.5 1.07 0.63 0.50-0.79 <0.001
AIM-HIGH niacin C; G + J + H + M 282 16.4 5.47 274 16.2 5.39 1.02 0.87-1.21 0.8
AleCardio PPAR-α/γ C; D + J 344 9.5 4.76 360 10.0 4.99 0.95 0.83-1.11 0.57
ALERT statin C; G + J + M 112 10.7 2.09 134 12.7 2.50 0.84 0.64-1.06 0.14
ALLHAT-LLT statin A 631 12.2 2.54 641 12.4 2.58 0.99 0.89-1.11 0.88
Alpha-Omega n-3 fatty acids B 336 14.0 4.11 335 13.8 4.05 1.02 0.87-1.17 0.93
ASCOT-LLA statin J + G 100 1.9 0.59 154 3.0 0.91 0.65 0.50-0.83 0.0005
 diabetes substudy statin B 116 9.2 2.79 151 11.9 3.59 0.78 0.61-0.98 0.04
ASPEN statin C; D + J + M + O + L 166 13.7 3.43 180 15.0 3.75 0.91 0.73-1.12 0.34
AURORA statin C; J + D 396 28.5 7.50 408 29.5 7.76 0.97 0.84-1.11 0.59
 diabetes substudy statin C; G + J 85 21.9 7.82 104 30.3 10.83 0.72 0.51-0.90 0.008
BIP fibrate C; K + J + P 211 13.6 2.20 232 15.0 2.43 0.91 NR 0.26
CARDS statin C; H + M + T 83 5.8 1.49 127 9.0 2.31 0.65 0.48-0.83 0.001
CARE statin G + J 212 10.2 2.04 274 13.2 2.64 0.77 0.09-0.36 0.003
 diabetes substudy statin G + J + M 81 28.7 5.74 112 36.8 7.37 0.78 NR <0.0001
CDP (clofibrate) fibrate A 281 25.5 4.11 709 25.4 4.10 1.00 NR NR
CDP (niacin) niacin A 273 24.4 3.93 709 25.4 4.10 0.96 0.85-1.08 NR
dal-OUTCOMES CETP inhibitor C; G + J + L + O 656 8.3 3.20 633 8.0 3.09 1.04 0.93-1.16 0.52
DIS fibrate E 32 8.4 1.69 31 8.1 1.62 1.04 NR NR
FIELD fibrate C; B + D + I + M 256 5.2 1.05 288 5.9 1.18 0.89 0.75-1.05 0.16
GISSI-Prevenzione statin C; A + I 120 5.6 2.77 136 6.4 3.15 0.88 0.71-1.15 0.41
GREACE statin C; A + J + L + Q + M 112 12.7 4.24 180 25.0 8.33 0.51   <0.0001
 diabetes substudy statin C; A + J + L + Q + M 20 12.4 4.14 46 30.3 10.09 0.41 NR <0.0001
HATS statin + niacin§§§ R + B; D + J + M 7 9.6 3.20 12 35.3 11.76 0.27 NR 0.02
HHS fibrate C; K + J + G 56 2.7 0.55 84 4.1 0.83 0.66 0.08-0.53 <0.02
 diabetes substudy fibrate C; K + J + G 2 3.4 0.68 8 10.5 2.11 0.32 NR 0.19
HPS - MRC/BHF statin C; A + G 1328 12.9 2.59 1507 14.7 2.94 0.88 0.81-0.94 0.0003
 diabetes substudy statin E + B 601 20.2 4.20 748 25.1 5.22 0.81 0.19-0.30 <0.0001
HPS2-THRIVE niacin C; G + M 1696 13.2 3.39 1758 13.7 3.51 0.96 0.90-1.03 0.29
IDEAL statin C; G + J + O 411 9.3 1.93 463 10.4 2.17 0.89 0.78-1.01 0.07
ILLUMINATE CETP inhibitor C; G + J + L 464 6.2 6.16 373 5.0 4.95 1.24 1.09-1.44 0.001
JELIS n-3 fatty acids E; P; I; L; M; A 262 2.8 0.61 324 3.5 0.76 0.81 0.69-0.95 0.01
LEADER fibrate E 150 19.2 4.95 160 20.4 5.20 0.95 0.76-1.21 0.72
LIPID statin G 287 6.4 1.04 373 8.3 1.36 0.77 0.12-0.35 <0.001
LIPS statin C; G + J + M 181 21.4 5.50 222 26.7 6.83 0.80 0.64-0.95 0.01
MEGA statin C; I + L + M + P 66 1.7 0.32 101 2.5 0.48 0.67 0.49-0.91 0.01
ORIGIN n-3 fatty acids D; D + J + U; A; I; T; M + W; Q; L; Z 574 9.1 1.47 581 9.3 1.50 0.98 0.87-1.10 0.72
PERFORM antiplatelet D; I 1091 11.4 4.83 1062 11.1 4.71 1.03 0.94-1.12 NS
Post-CABG statin C; D + J + M 207 30.6 4.08 271 40.1 5.35 0.76 NR 0.04
PREDIMED TMD C; D + I 179 3.6 0.80 109 4.4 1.12 0.71   
PROACTIVE glitazone C; A + J + H + M 514 19.7 6.80 572 21.7 7.49 0.91 0.80-1.02 0.1
PROFIT-J glitazone C; A + J 9 3.8 2.09 10 4.0 2.20 0.95 0.427-2.593 0.91
PROSPER statin C; G + J 408 14.1 4.41 473 16.2 5.07 0.87 0.74-0.97 0.01
RPS n-3 fatty acids D 733 11.7 2.35 745 11.9 2.38 0.99 0.88-1.08 0.64
SHARP statin/ezetimibe C; J + G + M 526 11.3 2.31 619 13.4 2.73 0.84 0.74-0.94 0.0021
STABILITY Lp-PLA2-inhibitor C; D + J + U 769 9.7 2.62 819 10.4 2.80 0.94 0.85-1.03 0.2
STENO-2 statin/fibrate A 24 30.0 2.26 40 50.0 3.76 0.60 0.32-0.89 0.02
TNT statin C; G + J + O + T 434 8.7 1.77 548 10.9 2.23 0.79 0.69-0.89 <0.001
 diabetes substudy statin C; G + J + O + T 103 13.7 2.79 135 18.0 3.68 0.76 0.58-0.97 0.026
VA Cooperative Study fibrate A + B 22 8.2 4.56 30 11.4 6.31 0.72 0.43-1.22 NR
VA-HIT fibrate C; J + G 219 17.3 3.40 275 21.7 4.26 0.80 0.07-0.35 0.006
 diabetes substudy fibrate C; J + G 96 25.5 4.99 141 36.0 7.05 0.71 0.53-0.88 0.004
Total (n)    16156    18445      
Mean     12.2 3.0   14.8 3.6 0.85   
  1. §: see legend to Table 1 for study acronyms definition; §§: see Table 2 for CV outcomes definition; §§§: ±antioxidants; CETP: cholesteryl ester transfer protein; CI: confidence interval; CV: cardiovascular; HR: hazard ratio; LpPLA2: lipoprotein-associated phospholipase A2; NR: not reported; NS: non significant; PPAR: peroxisome proliferator-activated receptor; TMD: traditional Mediterranean diet
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Cardiovascular Diabetology

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