| Study characteristics |
| Methods |
Randomised control trial. |
| Participants |
2838 participants with diabetes based in UK and Ireland aged 40‐75 years (mean 61.7); 68% men; 94.5% Caucasian. None with any clinical evidence of CVD. |
| Interventions |
10 mg atorvastatin, all patients were given counselling on cessation of smoking; follow up of 3.9‐4 years. |
| Outcomes |
Primary: composite of fatal and non‐fatal MI, acute CHD death, resuscitated cardiac arrest. Single outcomes included: all‐cause mortality, fatal and non‐fatal or silent MI + stroke, revascularisation, resuscitated cardiac arrest, total CVD events, adverse events and cholesterol. |
| Notes |
Trial stopped prematurely due to large beneficial treatment effect. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Computer‐generated randomisation code |
| Allocation concealment (selection bias) |
Low risk |
Staff and patients unaware of computer‐generated randomisation code |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Triple‐blind: participants, personnel and outcome assessors |
| 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 |
