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