Bristol-Myers Study Backfires

A new study of cholesterol-reducing drugs in the statin family holds good news for heart disease sufferers but bad news for the study's sponsor, Bristol-Myers Squibb.

The study is called Pravastatin or Atorvastatin Evaluation and Infection Therapy, or PROVE IT. Bristol-Myers launched it in 2002 in an effort to demonstrate that its Pravachol brand pravastatin works as well as Pfizer's Lipitor (atorvastatin calcium) at preventing major cardiovascular events.

The results, revealed last week at the American College of Cardiology meeting in New Orleans, were not what Bristol-Myers was expecting. The Harvard Medical School researchers who conducted the study found that patients taking Lipitor had a 16% lower risk of heart attacks or death than those taking Pravachol.

Lipitor is already the biggest selling statin--and the number one drug in the world--with 2003 sales of $9.2 billion. In contrast, Pravachol's sales were $2.8 billion last year and are in danger of slipping in the wake of the findings.

For heart patients, the study could herald a new era of aggressive statin-based therapy. According to Eric J. Topol, chairman of cardiovascular medicine at the Cleveland Clinic and author of an editorial in the New England Journal of Medicine edition in which the study appears, the conventional therapeutic approach has been to lower patients' low-density lipoprotein (LDL) cholesterol levels to less than 100 mg per deciliter of blood.

However, the high doses of Lipitor given in the PROVE IT study reduced LDL levels to well below that--62 mg on average. LDL levels among Pravachol recipients, on the other hand, averaged 95 mg. Based on the improved mortality associated with the much lower cholesterol levels, Topol predicts that "there will soon be a sea change" in the prevention and management of cardiovascular disease.