Table A [posted as supplied by author] Randomised controlled trials of statins and disease events: individual trial data


Trial (acronym¶)

Cholesterol

lowering

drug

No of participants

Mean LDL

cholesterol reduction

(mmol/l)

Ischaemic heart disease events by time period

Strokes

Adverse effects of statins

£ 1 year

 

1.1-2 years

2.1 - 5 years

> 5 years

 

all

 

fatal

 

Elevated ALT±

 

Elevated CPK§

Diagnosis of rhabdomyolysis

tr

plac

tr

plac

 

tr

plac

tr

plac

tr

plac

tr

plac

tr

plac

tr

plac

tr

plac

tr

plac

Without known vascular disease on entry

ASCOT-LLAw165

atorvastatin

5168

5137

1.2

14

13

 

13

15

28

53

-

-

89

121

-

-

-

-

-

-

1

0

AFCAPS/TexCAPSw166,w167

lovastatin

3304

3301

1.0

12

17*

 

14

19

27

49

4

10

-

-

-

-

18

11

21

21

1

2

EXCELw40†

lovastatin

6582

1663

1.4

62

20

 

-

-

-

-

-

-

11

1

10

1

45

2

17

7

0

0

PROSPERw168†

pravastatin

2819

2913

1.1

86

101

 

91

111

115

144

-

-

135

131**

22

14

1

1

0

0

0

0

WOSCOPSw169

pravastatin

3302

3293

1.0

40

55

 

32

50

95

135

7

8

46

51

6

4

16

12

3

1

0

0

KAPSw170,w171†

pravastatin

224

223

1.6

3

2

 

2

4

0

2

-

-

2

4

0

1

4

3

-

-

-

-

With known vascular disease on entry

MIRACLw10,w172

atorvastatin

1538

1548

1.6

155

169

 

-

-

-

-

-

-

12

24

3

2

38

9

-

-

0

0

GREACEw173

atorvastatin

800

800

1.8

9

25

 

10

24

19

38

-

-

9

17

0

0

7

3

-

-

0

0

LIPSw174

fluvastatin

844

833

1.0

23

26

 

6

11

13

23

-

-

-

-

2

1

10

3

0

3

0

0

FLAREw175

fluvastatin

409

425

1.4

6

17

 

-

-

-

-

-

-

0

0

0

0

-

-

-

-

-

-

LCASw176,w177

fluvastatin

157

164

0.6

  

7 6 ‡

  

-

-

-

-

0

0

0

0

2

0

1

2

-

-

Riegger et alw178

fluvastatin

187

178

1.0

2

5

 

-

-

-

-

-

-

0

0

0

0

0

0

0

1

-

-

Post CABGw179

lovastatin

676

675

1.1

10

8*

 

12

7

13

25

-

-

17

16

4

4

-

-

-

-

0

0

ACAPSw39

lovastatin

460

459

0.9

2

2

 

2

4

1

3

-

-

0

5

0

2

6

6

-

-

0

0

CCAITw180

lovastatin

165

166

1.2

  

7 7 ‡

  

-

-

-

-

2

0

0

0

-

-

-

-

-

-

Sahni et alw181

lovastatin

79

78

0.7

3

4

 

-

-

-

-

-

-

0

0

0

0

-

-

-

-

-

-

LRTw182

lovastatin

203

201

1.2

5

1

 

-

-

-

-

-

-

0

1

0

0

3

1

3

0

-

-

LIPIDw183-w185

pravastatin

4512

4502

1.0

113

144

 

96

115

256

325

92

131

169

204

22

27

112

119

6

1

0

0

CAREw185-w187

pravastatin

2081

2078

1.0

59

59 *

 

42

42

95

153

16

20

54

78

10

6

0

0

ALLHATw188

pravastatin

5170

5185

0.6

82

88 *

 

66

75

232

258

-

-

209

231

53

56

-

-

-

-

-

-

PLAC 1&2w171,w189

pravastatin

281

278

1.2

9

11

 

2

11

3

7

-

-

1

5

0

2

-

-

-

-

-

-

REGRESSw83,w171

pravastatin

450

434

1.2

6

6

 

4

9

-

-

-

-

2

4

0

0

-

-

-

-

-

-

PREDICTw100

pravastatin

347

348

1.0

7

5

 

-

-

-

-

-

-

0

0

0

0

-

-

-

-

-

-

PMSGw101†

pravastatin

530

532

1.3

0

7

 

-

-

-

-

-

-

0

3

0

0

6

1

0

0

0

0

FASTw190†

pravastatin

83

81

1.1

1

6

 

3

5

-

-

-

-

0

0

0

0

-

-

-

-

-

-

probucol

82

0.8

1

 

1

-

-

0

0

      

Heart Protection Studyw191,w192†

simvastatin

10269

10267

1.0

188

208

 

162

226

548

778

-

-

462

618

96

119

182

163

11

6

5

3

4Sw156

simvastatin

2221

2223

1.7

114

137

 

69

105

159

271

27

49

70

98

14

12

33

49

6

1

1

0

SCATw193

simvastatin

230

230

1.1

  

17 13 ‡

  

-

-

-

-

4

7

2

2

-

-

-

-

-

-

MAASw144

simvastatin

193

188

1.3

  

8 3 ‡

  

6

5

-

-

1

2

0

0

0

0

-

-

0

0

CISw194

simvastatin

129

125

1.4

  

2 7 ‡

  

-

-

-

-

0

0

0

0

-

-

-

-

-

-

HATSw195

simvastatin+niacin 38

38

38

1.2

1

1

 

0

2

0

2

-

-

0

2

0

2

-

-

-

-

-

-

All trials

                 

449||

383

55||

43

8

5

¶The expansion of the acronyms is given in the citations

±Alanine aminotransferase; "elevated" defined as ³ 3 times upper limit of normal (>2 for ACAPS, HPS)

§Creatine phosphokinase; "elevated" defined as ³ 10 times upper limit of normal in the absence of myocardial infarction

*Numbers of ischaemic heart disease events by time period estimated from published survival curves

†Most but not all participants were in the specified category of disease on entry or no disease on entry

** 61 & 62 in participants without and 74 & 69 with known vascular disease on entry

‡In these trials numbers of events were available for the first two years but not the first and second years separately

||After adjusting the EXCEL trial result for the fourfold greater number of treated than placebo subjects