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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

ISSN: 1475-2840