FDA Okays Crestor for Healthy People: What You Need to Know

Last month the FDA approved Crestor, a cholesterol lowering medication or statin, for prevention of heart attacks and stroke in healthy people.  In the past, this medication, made by AstraZeneca along with others, is only indicated for people with high levels of bad cholesterol. Cholesterol is said to be associated with high risk of heart disease and stroke, but not all studies suggest the same thing.

A FDA panel of experts voted 12 to 4 to allow Crestor to be used in healthy people who smoke or have high levels of inflammation indicated by elevated levels of C-reactive protein or high blood pressure.  The FDA adapted the panel's recommendation.

 A trial of 18,000 healthy people revealed that taking Crestor for one year can reduce risk of heart attacks by 55 percent and stroke by 48 percent. There is a catch, however.  Using Crestor increased the  risk of diabetes by 8 percent.

By percentage, the statin can greatly reduce incidence of heart attacks and stroke. But in reality, because all the subjects were healthy, the incidence of heart attacks was only 0.37 percent of those who did not take Crestor compared to 0.17 percent in those who took the statin.  The absolute risk of heart attack and stroke was reduced by 0.2 percent, which means 2 cases out of 1000 healthy patients on this statin can be prevented.

The NY Times report does not say how many diabetes cases would result from taking Crestor. In the United States, the diabetes rate is known to be about 7 percent. Taking Crestor for one year would increase diabetes risk by 8 percent, meaning that of 1000 people who take the medication, 5.6 new diabetes cases will result by the writer's calculation.

These data suggest that it would take 500 healthy people to take the statin for one year to prevent one usually survivable heart attack and this is true also for stroke.

Experts who have financial ties with the drug manufacturer can't wait to agree that this statin should be given to those who are healthy, but the drugs have some risk factors that are not directly related to heart attacks and stroke.

Dr. Paul M. Ridker, a Harvard medical professor and cardiologist at Brigham and Women’s Hospital in Boston, who led the trial and received royalties from the company for his C-reactive protein test and Dr. Steven E. Nissen, chairman of cardiology at the Cleveland Clinic, who has consulted for the company, are among these experts.

Experts like Dr. Steven W. Seiden, a cardiologist in Rockville Centre, N.Y. do not agree that taking statins is a good idea for healthy people.   Dr. Seiden was cited as saying that 500 people taking Crestor at $3.5 per pill per day for one whole year to prevent one usually survivable heart attack would cost the healthy patients $638,000.

Statins have been known to cause some serious adverse effects in patients.  Muscle injury is one obvious side effect from taking statins for a long term.

The FDA approval means that 6.5 million Americans are eligible for the Crestor.  Eighty million people have been using statins.   Crestor had sales of $4.6 billion last year. 

By David Liu and editing by Denise Reynolds