| Study characteristics |
| Methods |
Randomised trial. |
| Participants |
47 participants with hypercholesterolaemia based in Italy with a mean age of 51; 46% men. None with any clinical evidence of CVD. |
| Interventions |
80 mg fluvastatin versus placebo; all participants were given advice on diet and exercise ; follow‐up for one year. |
| Outcomes |
Adverse events, cholesterol. |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Envelopes containing randomisation codes prepared by statistician |
| Allocation concealment (selection bias) |
Low risk |
Allocation code could only be identified by statistician and person responsible for statistical analysis |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Single blind: participants |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
ITT used, no drop‐outs reported |
| Selective reporting (reporting bias) |
Low risk |
|
| Other bias |
Unclear risk |
Funded by pharmaceutical industry |
