The Pharmaceutical Journal
Vol 272 No 7303 p729
12 June 2004

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Lipid-lowering halves stroke risk in type 2 diabetes

Patients with type 2 diabetes treated with 10mg atorvastatin (Lipitor) daily have their risk for stroke halved and a reduced incidence of cardiovascular events compared with patients given placebo, a major UK study revealed this week.

The 2,838 patients in the randomised controlled primary prevention study had no prior history of stroke, heart disease or severe peripheral vascular disease and had low or average pre-treatment low-density lipoprotein (LDL) and triglyceride levels.

The collaborative atorvastatin diabetes study (CARDS), jointly funded by Diabetes UK, the Department of Health and Pfizer, was designed by researchers at University College London primarily to study the safety and efficacy of low-dose atorvastatin in type 2 diabetes. The trial, presented this week at the American Diabetes Association annual meeting in Florida, screened and recruited eligible type 2 patients aged 40 to 75 years from 132 UK and Irish centres who had an LDL cholesterol below 4.14mmol/L and one other cardiovascular risk factor (eg, hypertension or microalbuminuria). More than half had an LDL level below 3.3mmol/L and a quarter had a level of 2.6mmol/L or less.

Patients were randomised to either atorvastatin 10mg or placebo for five years. The primary endpoint was a composite of major coronary events, revascularisation, unstable angina, resuscitated cardiac arrest and stroke. However, the trial ended prematurely last year, after less than four years, when the data safety monitoring board found a significant difference in prespecified events.

Lead investigator Helen Colhoun, now at University College Dublin, said: “By the time CARDS ended, 127 events had occurred in the placebo arm and 83 in the atorvastatin arm, a relative risk reduction overall of 37 per cent.” This included 48 per cent less strokes. Total mortality was reduced by 27 per cent in the atorvastatin arm. During the trial, mean LDL cholesterol reduction was 40 per cent and absolute reduction 1.2 mmol/L. Benefits were regardless of age, gender and whether baseline LDL was above or below 3mmol/L. No differences emerged between study arms regarding adverse events.

“Findings suggest cholesterol level should no longer determine whether or not type 2 diabetes patients receive statins,” said Professor Colhoun. “The issue now is whether any reason can justify withholding statin treatment from this patient group.”