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. Under current treatment guidelines, an elevated CRP level wouldn't automatically trigger treatment with a cholesterol-lowering drug.
“The Jupiter study, which compared patients on Crestor to patients receiving a placebo or fake pill, showed a 44% reduction in the number of events that looked at a combination of death, stroke, heart attacks, hospitalization for heart problems and surgery to treat clogged arteries, after an average of 1.9 years. The study results were so strong that the study was stopped early.”
Last year, the drug’s sales totaled $3.6 billion. The researchers in the study have estimated that there might be six million more people in the United States who have elevated CRP but do not have alarming cholesterol levels.
ABC News puts the news in perspective in their lead:
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.
What about you? Would you take Crestor if your cholesterol levels were normal but your doctor recommended it preventatively? What if it caused some of its known negative side effects, such as headaches, nausea, memory loss, weakness or dizziness? Would you still take it?
The ABC news story:
http://abcnews.go.com/Health/HeartDiseaseNews/fda-panel-oks-statins-healthy-people/story?id=9350291
The Wall Street Journal Health story:
http://online.wsj.com/article/SB10001424052748704398304574598402303007392.html
The drugs.com page on Crestor, its currently approved uses, its guidelines and side effects:
http://www.drugs.com/crestor.html