FDA Panel Recommends Crestor to Prevent Heart Attacks in Healthy People
Dec. 16, 2009— -- The joke in the world of heart disease is that "they should put statins in the water," but to a U.S. Food and Drug Administration advisory panel that has recommended giving statins to "healthy" people, it's no joke.
The panel voted 12 to four with one abstention to recommend that the potent statin Crestor (rosuvastatin) be approved to prevent heart attacks in people who have no history of heart disease and don't fit the traditional profile of an "at risk" population.
The FDA is not obligated to follow the advisors recommendations, but it often does. If it did so this time, it would mark a first -- a drug normally used to lower dangerously high LDL (bad) cholesterol in people with a history of heart disease or risk factors to develop heart attacks or strokes would be approved for the prevention of heart attacks in healthy people.
The new label as recommended by the advisors would state that the drug should be given to men age 50 or older and women age 60 or older who have LDL cholesterol of less than 130 mg/L and triglycerides of less than 500 mg/L if -- and this too is a first -- the patient also had an elevated blood level of C-reactive protein, a marker for inflammation.
The committee's vote was immediately seized upon by cardiologists who characterized it using terms ranging from "great news" to "courageous."
"If the FDA accepts this recommendation, it will expand the number of Americans eligible for statin therapy by millions," said Dr. Steven Nissen, chair of cardiovascular medicine at the Cleveland Clinic.
Dr. James Stein of the University of Wisconsin School of Medicine and Public Health called the vote "very significant," adding that if approved, "it will also, have the (possibly) unintended consequence of increasing highly sensitive CRP testing in the U.S."
Dr. Cam Patterson, a professor at the University of North Carolina School of Medicine, agreed with Stein. "It's been difficult to find a compelling reason to order CRP levels on patients," Patterson said. "This is some guidance from the FDA about how to take high CRP levels into account, and that is good news."
