Lipitor halves stroke risk in diabetes patients
pharmafile | June 8, 2004 | News story | |
New Lipitor data suggests the drug cut the risk of stroke by half in diabetes patients, the compelling evidence potentially leading to a change in prescribing practices and an expanded licence for the blockbuster cholesterol drug.
The Collaborative Atorvastain Diabetes Study (CARDS) was co-ordinated by the University College of London through a unique collaboration between the university, Diabetes UK, the Department of Health and Pfizer UK.
More than 2,800 patients with type II diabetes who had no existing cardiovascular disease took part in the trial comparing 10mg atorvastatin (Lipitor) to a placebo, but evidence of its benefits were so overwhelming that the trial was stopped early.
Research leader Professor John Betteridge of University College London said: "In this study, patients on atorvastatin experienced major cardiovascular benefits so much so that the trial was stopped early because it would be unfair to those receiving placebo to continue.
"Currently, only patients with diabetes with elevated cholesterol or established heart disease routinely receive statins but this study shows that even those without CVD or high cholesterol could benefit from cholesterol-lowering."
The study findings said thousands of lives could be saved and Diabetes UK called for doctors to prescribe atorvastatin to diabetes patients at time of diagnosis.
"People with diabetes spend 1.1 million days in hospital in the UK every year. Two thirds of this time is as a result of cardiovascular disease, much of which could be prevented. Doctors should now consider all of their patients with diabetes for statin therapy," said Simon Oeill, head of information and education at Diabetes UK.
The study presented at the American Diabetes Association conference in Orlando, Florida showed Lipitor reduced cardiovascular events by 37% in those without cardiovascular disease (CVD) and the risk of stroke was substantially reduced by 48%.
The new trial data is good news for Lipitor's manufacturers Pfizer, opening up possible new licenses in global markets for the prevention of coronary or cardiovascular events, bolstering its position as the world's biggest selling drug.
The Department of Health said the study findings will add to the development of diabetes health policy and also feed into NICE guidance.
About 1.4 million people in the UK are known to have diabetes and over three-quarters of people with diabetes have type II diabetes. Stroke is the third most common cause of death in the UK and the single biggest cause of disability among adults.
