Pfizer’s blockbuster cholesterol-lowering drug, Lipitor (atorvastatin), has been approved in the USA to prevent the cardiovascular complications of type 2 or adult onset diabetes, which affects 18 million Americans.

The US Food and Drug Administration has cleared new labelling for the drug indicating it can reduce the risk of stroke or heart attack in diabetics, as well as patients without diabetes but with other risk factors for cardiovascular diseases, including high cholesterol, high blood pressure, family history, age over 55, smoking, diabetes and obesity.

The expanded labelling will cement Lipitor’s position as the leading cholesterol-lowering treatment and help protect the product from the effects of competition. The early drugs in the statin class are starting to lose their patent protection, and notably Merck & Co’s Zocor (simvastatin) will go off patent in the USA next year. Meanwhile, increased competition is expected to come from newer drugs such as Merck & Co and Schering-Plough's Vytorin (simvastatin plus ezetimibe), which is capturing a healthy share of new prescriptions in the US market [[22/07/05c]].

Lipitor remains the top-selling drug in the world, with sales of more than $11 billion dollars in the 12 months ended July 2005, although its growth has started to decelerate, according to IMS Health data [[15/09/05d]].

The approval in diabetes was based on the findings of the Collaborative Atorvastatin Diabetes Study (CARDS), a trial involving more than 2,800 patients with type 2 diabetes, which showed patients on Lipitor experienced nearly 50% fewer strokes than those on placebo [[17/06/03c]]. Approval in high-risk, non-diabetic patients came on the back of the Anglo-Scandinavian Cardiac Outcomes Trial: Lipid-Lowering Arm (ASCOT-LLA) trial [[03/08/04a]].

Around 65% of diabetics will go on to suffer a heart attack or stroke, a rate that is up to four times higher than in adults without the disease.