U.S. prescriptions for cholesterol-lowering medications predating statins have increased steadily despite uncertain benefit, suggesting that aggressive marketing has trumped scientific evidence.
These drugs, called fibrates, modestly reduce blood levels of artery-clogging bad cholesterol, raise good cholesterol and are most effective at lowering levels of other damaging blood fats called triglycerides, although the overall picture from clinical trials remains confusing.
Fibrates include gemfibrozil (Lopid), which got the regulatory nod in 1981; fenofibrate (TriCor, Triglide), approved in 2007, and the closely related drug fenofibric acid (TriLipix, Fibricor), which entered the U.S. pharmaceutical marketplace in December 2008. In 2009, fenofibrate and fenofibric acid together accounted for almost 74 percent of the U.S. market share of fibrates.
According to Dr. Cam Patterson, cardiology chief and physician-in-chief 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. Fibrates may be an option as add-on therapy, but there is no compelling case to use them as first-line therapy" for patients with elevated cholesterol, he warns.
Patterson feels the substantial increase in fibrate use demonstrated "unfortunate tribal behavior by physicians that is no doubt driven by the big pharma marketing machinery" and expressed concern about the ramifications of "recommending costly medications that don't confer real benefits to our patients. We've been burned before."
"The use of fibrates in America is very troubling," says Dr. Steven E. Nissen, chairman of cardiovascular medicine at the Cleveland Clinic Foundation. Describing the increasing use of fibrates as an expensive failure to educate doctors and regulators, he notes that fibrates are among medications advertised directly to consumers. “This is a classical example of marketing triumphing over science," he feels.
Dr. James H. Stein, director of preventive cardiology at the University of Wisconsin-Madison School of Medicine and Public Health, says most people don't realize the influence of marketing on health care. Pointing out that negative studies about fibrates have been "spun to focus on the possible benefits", he cautions that fenofibrate is associated with significant side effects, including "increased creatinine, which might indicate kidney dysfunction; gallstones, and more serious complications like pancreatitis, blood clots, and pulmonary embolism."
In the past five years, two major studies have found fenofibrate failed to reduce heart disease risks among diabetic men and women. Last year, the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial, which involved 10,000 patients with diabetes, found that those who took both simvastatin and fenofibrate suffered about as many heart attacks, strokes and deaths as diabetic patients treated with simvastatin alone.
The Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) trial, which involved nearly 10,000 patients and has reported results since 2005, found that fenofibrate failed to decrease cardiovascular deaths more than a placebo.
Yet a new study published in the current issue of the Journal of the American Medical Association found that U.S. prescriptions for fibrates grew from 336 per 100,000 people in January 2002, to 730 per 100,000 people in December 2009. That's a 117.1 percent hike. At the same time, Canadian prescriptions for fibrates held nearly steady, at 402 per 100,000 in early 2002 and 474 per 100,000 in late 2009.
The increase in fibrate prescriptions, driven by a 200 percent jump in the use of fenofibrate, has outpaced the growth of statins. But, to keep things in perspective: statins, which are among the most commonly prescribed medications, remain blockbuster drugs that dominate lipid-lowering treatment, with fibrates accounting for just 9.4 percent of the U.S. lipid-lowering market in 2009.
Based on a news report in ABC News
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