WOSCOPS, 1995 trial summary    PDF trial summary

A randomised clinical trial investigating the effect of pravastatin versus placebo in men aged 45-64 yr with no history of myocardial infarction and with raised plasma cholesterol levels (LDL cholesterol of at least 155 mg/dL, total cholesterol of at least 252 mg/dL)

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J Clin Epidemiol 1992;45:849-60
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Studied treatment pravastatine 40 mg daily
Control treatment placebo
Concomittant treatmentdiet
Age (mean), yrs 55 yr
Women (%) 0
Total cholesterol (mmol/l) 7.1 mmol/L
total cholesterol change 20.0%
LDL change, end of study (%) -26%
HDL change +5%



Patients men aged 45-64 yr with no history of myocardial infarction and with raised plasma cholesterol levels (LDL cholesterol of at least 155 mg/dL, total cholesterol of at least 252 mg/dL)
Group sizes3302 / 3293
Inclusion criteriafasting LDL cholesterol level of at least 155 mg per deciliter during the second and third visits, with at least one value of 174 mg per deciliter or above (4.5 mmol per liter) and one value of 232 mg per deciliter or below (6.0 mmol per liter); no serious ECG abnormalities according to Minnesota code 1 (pathologic Q waves), 4-1, 5-1, or 7-1-1 or arrhythmia such as atrial fibrillation; and no history of myocardial infarction or other serious illness, although men with stable angina who had not been hospitalized within the previous 12 months were eligible
prior MI or CHD (%) 5%
LDL (mmol/l) 4.99 mmol/L
HDL (mmol/l) 1.14 mmol/L
Triglycerides (mg/dl) 163
Diabetes(%) 1%
BMI (kg/m2) 26
Stroke history NA
LV hypertrophy NA
History of hypertension (%) 15%



Blindness double blind Inclusion period Fev 1989 - Sep 1991
Follow-up duration 4.9 years Centers multicenter
Lost to FU geographical localisation Scotland
Primary endpoint coronary events (CHD death, MI) Design Parallel groups
PeriodeInclusionFev 1989 - Sep 1991
HypotheseSuperiority



EndpointX1N1X0N0TE95% CI coronary events 174 3302 248 3293 0,70[0,57; 0,85] all cause deaths 106 3302 136 3293 0,78[0,60; 1,01] cardiovascular death 50 3302 73 3293 0,68[0,48; 0,98] cardiovascular events 145 3302 248 3293 0,58[0,47; 0,72] venous thromboembolism - 3302 - 3293 no data fatal stroke 6 3302 4 3293 1,50[0,42; 5,31] Haemorrhagic strokes - 3302 - 3293 no data coronary deaths 38 3302 52 3293 0,73[0,48; 1,11] stroke (fatal et non fatal) 46 3302 51 3293 0,90[0,60; 1,34] CV events (including revascularization) - 3302 - 3293 no data MI non fatal 143 3302 204 3293 0,70[0,56; 0,87] Infarctus non mortel et décès coronariens 174 3302 248 3293 0,70[0,57; 0,85] cardiac death 38 3302 52 3293 0,73[0,48; 1,11] non cardiovascular death 68 3302 83 3293 0,82[0,59; 1,13] Pancreatitis 2 3302 5 3293 0,40[0,08; 2,06] AST >3 x ULN - 3302 - 3293 no data ALT >3 x ULN - 3302 - 3293 no data CPK >10 x ULN - 3302 - 3293 no data incident diabetes 75 2999 93 2975 0,79[0,57; 1,09] Rhabdomyolyses 0 3302 0 3293 1,00[0,02; 50,28] décès par cancer 44 3302 49 3293 0,90[0,60; 1,35] Cancers mortels et non mortels - 3302 - 3293 no data Myopathies - 3302 - 3293 no data adverse events - 3302 - 3293 no data0,22,01,0

Shepherd J, Cobbe SM, Ford I, Isles CG, Lorimer AR, MacFarlane PW, McKillop JH, Packard CJ, Prevention of coronary heart disease with pravastatin in men with hypercholesterolemia. West of Scotland Coronary Prevention Study Group. N Engl J Med 1995; 333:1301-7     [PMID: 7566020]   link to pdf   add to Mendeley  

A coronary primary prevention study of Scottish men aged 45-64 years: trial design. The West of Scotland Coronary Prevention Study Group. J Clin Epidemiol 1992;45:849-60     [PMID: 1624967]   link to pdf   add to Mendeley  



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