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. 2013 Jan 31;2013(1):CD004816. doi: 10.1002/14651858.CD004816.pub5

WOSCOPS.

Study characteristics
Methods Randomised trial.
Participants 6595 men with hypercholesterolaemia based in Scotland aged 45‐64 (mean age 55). < 10% with clinical evidence of CVD.
Interventions 40 mg pravastatin versus placebo; follow‐up 4.9 years.
Outcomes Primary outcome: composite of non‐fatal MI and CHD death. Single outcomes included total mortality, fatal CVD events, cholesterol, revascularisations, non‐fatal MI and CHD death and adverse events.
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Blocks of random numbers and treatment assigned randomly
Allocation concealment (selection bias) Low risk All trial personnel remained unaware of the participant's treatment assignment throughout the study.
Blinding (performance bias and detection bias)
All outcomes Low risk Double‐blind: participants and personnel
Incomplete outcome data (attrition bias)
All outcomes Low risk ITT used, 30% drop‐outs reported
Selective reporting (reporting bias) Low risk  
Other bias Unclear risk Funded by pharmaceutical industry

BMD: bone mineral density
CHD: coronary heart disease
CIMT: carotid intima media thickness
CVD: cardiovascular disease
DXA: Dual‐energy X‐ray absorptiometry
ITT: intention‐to‐treat
LDL: low density lipoprotein
MI: myocardial infarction
TC: total cholesterol
TIA: transient ischaemic attack