| Study characteristics |
| Methods |
Randomised trial. |
| Participants |
305 participants with hypercholesterolaemia based in Italy with mean age 55; 53% men. None with any clinical evidence of CVD. |
| Interventions |
40 mg pravastatin versus placebo; follow‐up of three years. |
| Outcomes |
Slope of carotid artery, fatal and non‐fatal MI, angina, revascularisations, cholesterol and adverse events. |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Independent co‐ordinating centre controlled allocation |
| Allocation concealment (selection bias) |
Low risk |
Independent co‐ordinating centre controlled allocation |
| Blinding (performance bias and detection bias)
All outcomes |
Unclear risk |
Double‐blind: participants and personnel |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
ITT used, 13% dropped out |
| Selective reporting (reporting bias) |
Low risk |
|
| Other bias |
Unclear risk |
Funded by pharmaceutical industry |
