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CARDS TRIAL |
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| Problem | T2DM |
| Format | Double-blinded multi-center RCT |
| Treatment | Atorvastatin 10mg |
| Control | Placebo |
| Population | 2838 patients |
| Inclusion criteria | Men and women aged 40–75 years with type 2 diabetes mellitus (deï¬Åned with 1985 WHO criteria) diagnosed at least 6 months before study, with at least one of: -History of hypertension, deï¬Åned as receiving antihypertensive treatment or having systolic blood pressure of 140 mm Hg or greater or diastolic blood pressure of 90 mm Hg or greater on at least two successive occasions -Retinopathy—ie, any retinopathy, maculopathy, or previous photocoagulation -Microalbuminuria or macroalbuminuria, deï¬Åned as a positive Micral or other strip test, an albumin creatinine ratio of 2·5 mg/mmol or greater, or an albumin excretion rate on timed collection of 20 g/min or more, all on at least two successive occasions -Currently smoking (no minimum number of cigarettes per day was required). All patients reporting current smoking were counselled to quit. |
| Exclusion criteria | Past history of myocardial infarction, angina, coronary vascular surgery, cerebrovascular accident, or severe peripheral vascular disease (deï¬Åned as warranting surgery). |
| Follow-up | Median 3.9 years |
| Primary endpoint | Time to first occurrence of the following: acute coronary heart disease events, coronary revascularisation, or stroke |
| Secondary endpoint(s) | Death from any cause, any acute cardiovascular disease event |
| Details | . |
| Brief summary: | Atorvastatin reduced CV events even in low LDL DM patients; stopped early due to benefit |
| PAPER: Primary prevention of cardiovascular disease with atorvastatin in type 2 diabetes in the Collaborative Atorvastatin Diabetes Study (CARDS): multicentre randomised placebo-controlled trial. | |
|---|---|
| Date | 21 Aug 2004 |
| Journal | Lancet. 2004 Aug 21-27;364(9435):685-96. |
| Information | Trial stopped early due to benefit -37% RRR for atorvastatin 10mg OD on major CV events (p=0.001) -All-cause mortality RRR of 27% p=0.059 -ACS by 36% -Stroke by 48% -Coronary revasc. by 31% No evidence to give treatment based on threshold LDL -2/3 of patients at/below recommended Rx LDL level of time |