| Study characteristics |
| Methods |
Randomised trial. |
| Participants |
2410 participants with type 2 diabetes based in 16 developed countries with mean age 60; 62.5% men; 84% Caucasian. < 10% with clinical evidence of CVD. |
| Interventions |
10 mg atorvastatin versus placebo; follow‐up of 2.4 years (for primary prevention participants). |
| Outcomes |
Primary: composite of fatal MI, stroke, sudden cardiac death, heart failure, CVD death. Single outcomes included: non‐fatal or silent MI + stroke, revascularisation, resuscitated cardiac arrest, TIA, unstable angina, peripheral arterial disease, Ischaemic heart failure and adverse events. |
| Notes |
Primary prevention participants recruited 2‐3 years into the study. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Not described |
| Allocation concealment (selection bias) |
Unclear risk |
Not described |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Double‐blind: participants and outcome assessors |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
ITT used 22% drop‐outs reported |
| Selective reporting (reporting bias) |
Low risk |
Other than not providing results on adverse events for primary prevention group |
| Other bias |
Unclear risk |
Funded by pharmaceutical industry |
