March 31, 2010 -- Millions of Americans who do not have high cholesterol may get advice at their next doctor's visit that they should be taking Crestor -- a drug known widely known as a cholesterol-busting statin but that research has shown could ward off heart problems in some patients with normal cholesterol, as well.
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However, plans by Crestor's maker to begin marketing the drug as a heart disease prevention measure to people previously viewed as "healthy" has doctors sharply divided on the benefits and risks of such an approach.
The U.S. Food and Drug Administration approved a new "indication" for the medication on Feb. 9. It supported the drug's use to reduce the risk of stroke, heart attack and certain heart procedures in men older than 50 and women older than 60 who have no diagnosis of high levels of LDL, or bad, cholesterol or coronary heart disease, but who have an elevated blood level of an inflammation marker known as C-reactive protein, or CRP, and at least one additional risk factor for heart disease, such as high blood pressure, a smoking habit or a family history of heart disease.
The new recommended use is based on the results of a study known as JUPITER, the results of which were so overwhelmingly in favor of Crestor use for a population of patients being given placebos that the trial was halted early.
AstraZeneca, the drug maker behind Crestor, now is taking steps to make the medical community aware of the drug's new target population.
"We obviously have a new indication, which means we are able to promote it [for those patients]," said Donna Huang, a spokeswoman for AstraZeneca.
Huang said that while the new recommended use would be promoted to doctors first, direct-to-consumer messages on the drug also could be changed in the future to target consumers who fall under the new indications.
Some say statin drugs in general, which boast an impressive safety profile, are a leading contributor to the drop in the country's heart disease deaths. But others cite research suggesting that using the cholesterol-busting drugs exposes patients to a range of possible side effects, from a form of muscle injury to a higher risk of developing Type 2 diabetes.
Doctors Disagree Over New Use
When the FDA's expert panel tabled its recommendation in December, it pitted cardiologists against many primary care physicians over the best use of Crestor, and many top heart experts still support the drug's new use.
Dr. Steven Nissen, chairman of the Department of Cardiovascular Medicine at the Cleveland Clinic Foundation, said that as long as the drug is used to treat those "healthy" adults who fall under the criteria of the study used to formulate the recommendation, "this FDA-approved indication is good for public health."
American Heart Association president Dr. Clyde Yancy said encouraging this new population to take the drug is justified, even if heart problems are rarer among such patients.
"Although the absolute event rates in this group are lower, these are not individuals with ideal health, and major cardiovascular events do occur," Yancy said. "The importance of a 40 to 50 percent reduction in events, i.e., heart attacks and strokes, cannot be ignored, especially when applied to the population at large."
Dr. Cam Patterson, chief of cardiology at the University of North Carolina at Chapel Hill School of Medicine, also supported expanding the criteria for who should be taking statins.
"The number of acute cardiac events that cardiologists see is shrinking compared to five or 10 years ago, and this is driven in large part due to wider use of statins," he said.
But Dr. Merle Myerson, director of Preventive Cardiology at St. Luke's-Roosevelt Hospital in New York, is one cardiologist who believes the move is worrying.
"I remain deeply concerned that this has, in a sense, opened the door to greatly expanded use of statins, especially prior to long-term studies establishing safety, efficacy, good benefit/risk profile, and that it is cost-effective," Myerson said. "I am very surprised that the FDA came out with this -- and rather quickly."
Lifestyle Choices Still Important, Doctors Say
The renewed debate also gave some primary care physicians and other doctors an opportunity to express their continuing concern over the new indication.
"I ... am reluctant to start statins on people who are not at at-least-moderate risk levels, as this really does make them 'patients' for life," said Dr. Eric Larson, director of the Center for Health Studies in Seattle.
Nissen said, however, that the risks of the drugs have been overblown by some.
"Provoking public fear of statins is not good public policy," Nissen said. "There are few therapies with such compelling evidence for benefit."
Still, Dr. Dean Ornish, an author and the director of the Preventive Medicine Research Institute in Sausalito, Calif., said there is at least one "prescription" for heart disease prevention that provides such compelling evidence.
"We have shown in our research, and others as well, that lifestyle factors such as poor nutrition, lack of exercise, chronic emotional stress, and social isolation are underlying causes of chronic inflammation," Ornish said. "Unlike the billions of dollars spent on statin drugs, with the attendant known and unknown side effects ... the only side effects of comprehensive lifestyle changes are good ones."
Yancy agreed that positive lifestyle changes should be combined with drug therapy for the best outcome.
"Any prevention approach must incorporate the proven safe and effective lifestyle adjustments that have already contributed to fewer heart attacks and strokes -- that's step one," Yancy said. "With strong adherence to lifestyle modification, individuals may rid themselves of many current indications for additional prevention measures."