You might have been surprised at the headlines that say that for the first time, the FDA might approve use of the cholesterol-lowering drug Crestor in people without high cholesterol. A powerful statin drug, it has been used in people who need to lower dangerously high LDL cholesterol – the bad kind – to try to prevent heart attacks or strokes.
After learning the results of a study of 18,000 people, the FDA advisory panel voted 12-4 (with one abstention) to recommend that the drug, which goes by the generic name rosuvastatin, be used preventatively in people with no history of heart attack or stroke.
The FDA doesn’t have to follow the advice, but usually does.
From ABC News:
“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."
The study was sponsored by the drug company AstraZeneca, which owns and manufactures the Crestor brand.
From the Wall Street Journal’s Health page:
“AstraZeneca sponsored an almost 18,000-patient study known as ‘Jupiter’ that looked at patients whose cholesterol levels were normal or slightly elevated but had an elevated C-reactive protein level.
“CRP is a marker of inflammation in the body and associated with a risk of developing several diseases, including cardiovascular disease.