Heart Drug 'Hype'? Docs Debate Crestor

Dec. 4, 2008— -- On Nov. 9, when the results of a trial on the use of statin drugs became public at the American Heart Association meeting, they were so promising that some heart experts believed they had the power to change medical practice.

Many felt the study would hail a new era in the use of the cholesterol-lowering drugs -- one in which more people would take these drugs for elevated levels of a heart disease marker known as C-reactive protein (CRP), and not for elevated cholesterol alone.

Now, nearly a month later, some primary care physicians say that such a shift has not yet occurred -- and that the benefits of the drug known as Crestor do not come without costs.

"The hype about this study is very far from the mark, scientifically," says Dr. Lee Green, a professor of family medicine at the University of Michigan in Ann Arbor.

"Lifestyle modification works better, and doesn't carry the risks of the medication," agrees Dr. Linda Prine, associate clinical professor at New York City's Beth Israel Medical Center.

Green adds that he feels the trial was an attempt by AstraZeneca, the drug's manufacturer, to resurrect a compound that has done poorly on the market due to side effects.

"This study is the ultimate research-as-marketing-tool achievement," Green says.

In an e-mailed statement to ABC News, AstraZeneca maintained that Crestor's safety profile is in keeping with that of other statins -- and that it is now up to doctors and others to use the data from the JUPITER trial as they see fit.

"As is appropriate, the medical community, regulators, and guideline committees will now carefully consider these data and any implications for treating patients," the statement reads.

After the Enthusiasm

The initial results from the JUPITER study appeared encouraging. The study, which examined the effect of Crestor (the trade name for the statin drug rosuvastatin) on healthy middle-aged patients with normal levels of "bad" cholesterol but elevated CRP levels, showed that those taking the drug enjoyed a reduced risk of heart attack, stroke and death.

Cardiologists were perhaps the most enthusiastic over the results. In an online poll conducted by the website Cardiosource last month, most respondents said they would measure CRP in at least some of their patients. Some cardiologists already use CRP to help them decide whether to prescribe statins to patients who already have certain heart risk factors; for them, JUPITER was one more piece of evidence that CRP testing could save lives.

"CRP is like a barometer of all the different risk factors," says Cardiosource editor Dr. Christopher Cannon, associate professor of medicine at Harvard Medical School and senior investigator in the TIMI Study Group.

And while non-cardiologist doctors tended to be somewhat more divided on the issue, many still anticipated that the research would make waves in clinical practice. Following the release of the study, the New England Journal of Medicine Web site polled medical professionals on whether they felt doctors should change their practice because of the study.

Of the more than 2,500 responses were received, 49 percent said the findings should affect laboratory testing, and 48 percent said statin drugs should be used differently in the wake of the trial.

Still, the drug is not without its risks. Side effects of the drug, which can range from mild to severe, include muscle and liver problems, as well as an increased risk of diabetes.

And some physicians say the fact that the trial was stopped early could have masked safety problems that may have occurred later on.

Critics also point out that while rosuvastatin cut rates of heart attack, stroke, and heart-related deaths by nearly half, very few of those not taking the drug -- less than 2 percent -- actually suffered these conditions. In short, it appears that the vast majority of people taking the drug would not have had these problems anyway.

"The [risk] reductions were actually tiny -- less than 1 percent reduction," Prine said.

So while the study authors claim that one life may be saved for as few as 25 patients treated with rosuvastatin, some say that many more patients -- and wallets -- will be affected if CRP screening to determine who should take rosuvastatin becomes routine.

"My 'back of the napkin' calculations suggest high cost per life saved," says Dr. Mark Ebell, professor of medicine and assistant to the provost at the University of Georgia.

Finding Common Ground

It may be that doctors' hesitance to charge ahead with widespread CRP screening is based on the idea that when it comes to this type of screening, what is reasonable for a particular patient may not necessarily be beneficial for an entire population.

"We have to be smart, looking at people not [just] as individuals, but as populations, too," says Dr. Gigi El-Bayoumi, a primary care physician and associate professor of medicine at George Washington University, who is concerned that widespread CRP testing may not be the best use of our collective healthcare dollars.

But if nothing else, last month's study may vindicate those who continue to look to the CRP test to guide their decisions on whether or not to prescribe cholesterol-lowering medication.

Dr. Greg Anderson, a primary care physician at the Mayo Clinic in Rochester, Minn., says that JUPITER may lead him to order more CRPs than in the past, "particularly in people with normal LDL but with other risk factors when trying to decide how aggressively to treat." But he adds that he will be more likely to treat elevated CRP with a generic statin rather than rosuvastatin, because the former is cheaper and more likely to be covered by insurers.

Indeed, many primary care physicians and cardiologists feel that the benefits seen from rosuvastatin in JUPITER are likely to extend to all statins.

"For now, the message is clear: statins are a once-in-a-lifetime class of drugs with a comparable safety profile, and with an across-the-board body of evidence for reduction in [heart attack and stroke]," says Dr. James Januzzi, associate professor of medicine at Harvard Medical School and staff cardiologist at Massachusetts General Hospital.

For El-Bayoumi's patient Anna Dixon, who has a family history of heart disease and stroke, the results of the trial are particularly relevant. While Dixon's level of "bad" cholesterol is relatively normal, El-Bayoumi has tested her CRP. If her CRP level turns out to be high, El-Bayoumi will recommend a statin.

"Over the last five years, I've had a variety of physicians tell me various and sundry things about cholesterol," says Dixon, an associate partner at IBM consulting who has taken pravastatin (Pravachol) in the past.

"I don't want to 'not take medicine' if it's prudent that I do…but I don't want anything in my body that I don't need."