Study characteristics |
Methods |
Randomised control trial. |
Participants |
17,802 participants (intervention:8901, control 8901) > 50 years. None with any clinical evidence of CVD. |
Interventions |
Rosuvastatin 20 mg daily. |
Outcomes |
First occurrence of major cardiovascular event, revascularisation, hospital admission for angina, MI, stroke, all‐cause death, CVD death and adverse events. |
Notes |
Stopped early with a follow‐up of 1.9 years. |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Low risk |
Randomisation done in block of 4, use of Interactive voice response system‐generated allocation sequence. |
Allocation concealment (selection bias) |
Low risk |
Stratified according to the centre |
Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Double blind, participants and outcomes assessed by end point committee |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
ITT used, no drop‐outs reported |
Selective reporting (reporting bias) |
Low risk |
There was limited data on LDL and TC at the end of trial |
Other bias |
High risk |
Groups comparable at baseline, including all major prognostic factors, structured interview assessing outcomes and adverse effects confirmed by independent expert committee. Trial was stopped early with a follow‐up of 1.9 years. Funded by pharmaceutical industry. |