Are Patients Being Misled About Cholesterol-lowering Drugs
The main question that doctors---and patients---ask about a prescription drug is simple: Does it work? Does this medicine improve the condition it's prescribed for?
In one recent case, the answer seems to be "No." A new report in The Journal of the American Medical Association has raised the alarm about fibrates, first-line therapy. "This is a classical example of marketing triumphing over science," said Dr. Steven Nissen, cardiovascular medicine chair at the Cleveland Clinic Foundation, in an interview with ABC News.
Fibrates predate statins, the most widely prescribed cholesterol-lowering drugs. (The best-known statin remains Lipitor, manufactured and marketed by Pfizer.) While fibrates reduce bad cholesterol and increase good cholesterol modestly, they're most effective at reducing triglycerides.
Doctors have increasingly turned to fibrates. From 2002 to 2009, prescriptions of the drugs increased by 117 percent in the United State. Their slice of the cholesterol medicine market remains modest, though---just 9.4 percent.
So what's the problem? According to studies, fibrates don't offer clear-cut benefits.
There have been two recent projects that looked at the drugs. The ACCORD (Action to Control Cardiovascular Risk in Diabetes) trial looked at 10,000 people. Those in the group who took simvastatin (Zocor) and fenofibrate didn't have particularly different outcomes from those who took only simvastatin.
The second study, the FIELD (Fenofibrate Intervention and Event Lowering in Diabetes) trial, had nearly as many participants as ACCORD. It looked only at fibrates and found that they didn't do any better than placebos at reducing heart disease deaths.
Doctors have had mixed reactions to the recent science.
Fibrates have "a lot of promise, but so far that promise is unfulfilled," said Dr. Cam Patterson of the Center for Heart and Vascular Care at the University of North Carolina, Chapel Hill. "Statins are the only cholesterol-lowering drugs that have been shown conclusively to save lives," Patterson told ABC. "Fibrates may be an option as add-on therapy, but there is no compelling case to use them as first-line therapy."
Some doctors said that lowering triglycerides---a strength of fibrates---could be important in treating obese patients. Others said that the drugs could be useful in patients who have trouble handling statins. Still others called for further research.