Table w1 Randomised clinical trials of cholesterol reduction: design, participant characteristics, and interventions

 

Trial (year published)

Primary or secondary prevention: participants

Mean age (years)

Mean baseline cholesterol (mmol/l)

Cholesterol lowering intervention

Other interventions*

Los Angeles Veterans Administration study (1969)

Primary prevention: men aged >55 years in domiciliary care

65

6.03

Cholesterol lowering diet (provided) v

conventional cafeteria diet

None

World Health Organization cooperative trial (1978)

Primary prevention: men aged 30-59 years without history of coronary heart disease and cholesterol concentration in top third of participants screened

46

6.41

Clofibrate 1.6 g/day v

placebo

None

Colestipol-Upjohn study (1978)

Primary prevention: adults aged >18 years with cholesterol >6.46 mmol/l (52% women)

51

7.96

Colestipol 15 g/day v

placebo

None

Lipid Research Clinics coronary primary prevention trial (1984)

Primary prevention: men aged 35-39 years without history of coronary heart disease, cholesterol >6.8 mmol/l

48

7.24

Colestyramine (cholestyramine) 24 g/day v

placebo

Dietary advice before randomisation

Helsinki heart study (1987)

Primary prevention: men aged 40-55 without history of coronary heart disease, non-HDL cholesterol >5.2 mmol/l

47

7.47

Gemfibrozil 1200 mg/day v placebo

Advice on cholesterol lowering diet, increased exercise, and reduction in smoking and weight

Minnesota coronary study (1989)

Primary prevention: adult residents of mental hospitals (51% women)

45

5.35

Cholesterol lowering diet v

control diet (both provided)

None

West of Scotland coronary prevention study (1995)

Primary prevention: men aged 40-64 years without history of myocardial infarction, cholesterol ³6.5 mmol/l

55

7.03

Pravastatin 40 mg/day v

placebo

Dietary advice before randomisation

Air Force/Texas coronary atherosclerosis prevention study (1998)

Primary prevention: men aged 45-73 and women aged 55-73 without history of vascular disease; HDL cholesterol £1.16 mmol/l for men and £1.22 mmol/l for women; "average" total cholesterol concentration (15% women)

58

5.71

Lovastatin 20-40 mg/day v

placebo

Dietary advice before randomisation

Oslo diet-heart study (1966)

Secondary prevention: men 30-64 years of age with a diagnosis of myocardial infarction 12-24 months previously

56

7.66

Instructed in reduced animal fat and cholesterol intake and increased vegetable oil intake v

no instructions

None

MRC soybean oil trial (1968)

Secondary prevention: men under 60 years old within 3 months of first myocardial infarction

N/A

7.06

Instructed in saturated fat restriction and soybean oil supplementation v

no instructions

Energy intake restriction in men with weight gain or obesity

Scottish Society of Physicians clofibrate trial (1971)

Secondary prevention: adults aged 40-69 years with angina pectoris and abnormal electrocardiograph, or myocardial infarction 2-4 months previously (17% women)

52

7.04

Clofibrate 1.8 g/day v

placebo (olive oil)

Energy intake reduction advice for overweight subjects

Coronary drug project (1975)

Secondary prevention: men aged 30-64 with myocardial infarction at least 3 months previously

44.4

6.41

Niacin 3 g/day v

Clofibrate 1.8 g/day v

Placebo

None

Stockholm ischaemic heart disease study (1988)

Secondary prevention: adults aged under 70 discharged with diagnosis of acute myocardial infarction (20% women)

59

6.43

Clofibrate 2 g/day and niacin 3 g/day v

no treatment

Instruction for reducing cholesterol and saturated fat; smoking cessation advice

Diet and reinfarction trial (1989)

Secondary prevention: men aged under 70 discharged with diagnosis of acute myocardial infarction

57

6.47

Instructed in reduced fat intake and increased polyunsaturate: saturate ratio to 1.0 v

no dietary fat advice

Smoking cessation advice; randomised to fish advice or no fish advice; randomised to fibre advice or no fibre advice

Partial ileal bypass surgery (1990)

Secondary prevention: adults aged 30-64 with myocardial infarction 6-60 months previously and total cholesterol ³5.69 mmol/l (9% women)

51

6.49

Partial ileal bypass surgery v

no surgery

Dietary advice

Helsinki heart study—ancillary study (1993)

Secondary prevention: men aged 40-55 years with previous myocardial infarction, electrocardiographic evidence of ischaemia or angina, and non-HDL cholesterol >5.2 mmol/l

49

7.00

Gemfibrozil 1200 mg/day v

placebo

Advice on cholesterol lowering diet, increased exercise, and reduction in smoking and weight

Scandinavian simvastatin survival study (1994)

Secondary prevention: adults aged 35-70 with history of angina pectoris or myocardial infarction at least 6 months previously, total cholesterol 5.5-8.0 mmol/l, and compliant during placebo run-in (19% women)

61

6.75

Simvastatin 10-40 mg/day v

placebo

Dietary advice before randomisation

Cholesterol and recurrent events trial (1996)

Secondary prevention: adults aged 21-75 years with myocardial infarction 3-20 months previously, total cholesterol <6.12 mmol/l, LDL cholesterol 2.97-4.50 mmol/l (14% women)

59

5.40

Pravastatin 40 mg/day v

placebo

Dietary advice before randomisation; colestyramine prescribed if LDL cholesterol remained >4.5 mmol/l

Long term intervention with pravastatin in ischaemic disease (1998)

Secondary prevention: adults aged 31-75 with myocardial infarction 3-36 months previously and total cholesterol 4.0-7.0 mmol/l (17% women)

62

5.64

Pravastatin 40 mg/day v

placebo

Dietary advice before randomisation

*Provided equally to both treatment groups.

LDL=low density lipoprotein; HDL=high density lipoprotein.