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.
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.
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."