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 studyancillary 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.