A new study suggests that a recent, major trial being used by many physicians as a guideline for prescribing cholesterol-lowering statin drugs to healthy adults may have missed the mark.
At the meeting of the American Heart Association (AHA) in Chicago today (Nov. 16), researchers from Johns Hopkins Hospital presented data suggesting that by using a measure different than the current one, doctors could more accurately determine which patients need to be on statins.
Increasingly, otherwise healthy people are being prescribed the drugs, which prompted the study.
“Since the threshold for giving people the statins has decreased over time…and we’re treating more healthy people…we just wanted to do a study to see if people put on statins can expect to collect some benefits,” said Dr. Michael Blaha, a cardiology fellow at Johns Hopkins Hospital and the study’s lead investigator.
“In healthy people with normal cholesterol, I don’t think everyone needs to be placed on a statin, which can be for life,” Blaha said.
Two major trials, different findings
Presented at the AHA meeting in 2008, a study called the JUPITER trial examined the possible benefits of statin treatment for people with normal cholesterol but high levels of C-reactive protein (CRP), a substance produced in the liver whose levels rise during inflammation. It was found that those with high CRP levels benefited from taking statins.
In the new study, researchers looked at data from a different group of patients — —people in the ongoing MESA trial conducted by the National Institutes of Health, which looks at atherosclerosis, or hardening of the arteries — and attempted to calculate how they would have fared if given statins. The researchers also looked at coronary calcium deposits, measured by CT scans of the chest.
Blaha said that using levels of calcium in arteries, rather than CRP levels, would have yielded better results, meaning many patients who were recommended to take statins should not have. And, he said, some with low CRP levels should have been on statins because of high coronary calcium levels.
Had calcium levels guided prescriptions, the researchers projected, 24 patients would need to be treated with statins for five years to prevent a single heart attack, and 19 would need to be treated to prevent a single heart attack or stroke.
According to the JUPITER trial’s results, 25 patients had to be treated for five years to prevent one heart attack. Based on the new trial, however, only about half as many people would be on statin treatments.
In other words, fewer people would be taking the drugs — and heart attack prevention would happen at a higher rate — if calcium deposits were guiding treatments.
“The numbers are highly efficient compared to other strategies” used when determining statin prescriptions, Blaha told My Health News Daily.
Given the nature of their research, Blaha said a new clinical trial would need to be done to verify the findings in a real — rather than a projected — clinical setting.
“I sense this study will add to the understanding about how these two issues, C-reactive proteins and calcium scores, interact,” said Dr. Robert Eckel, a past president of the American Heart Association. “How it will affect medicine remains untested.”
While calcium measurements may turn out to be a better measure of who needs statins, Eckel said, this study was done on a narrow group of patients who have certain risk factors for heart disease. Running widespread CT tests for calcium will be a problem, both because of the potential risks from radiation exposure and the expense — each CT scan costs several hundred dollars, while the test for CRP is around $10.
“CRP is cheap, [though] it may be uninformative,” said Eckel. “At this point, neither of these tests can be front and center.”
Corporate sponsorship and criticisms
The JUPITER trial has been criticized in some quarters for misinterpreting findings, believed to be a consequence of its sponsorship by AstraZeneca, manufacturers of the statin drug Crestor.
In an article appearing in the medical journal the Archives of Internal Medicine in June, Dr. Michel de Lorgeril of the Joseph Fourier University in France and others reanalyzed the JUPITER data, and concluded, “The results of the trial do not support the use of statin treatment for primary prevention of cardiovascular diseases and raise troubling questions concerning the role of commercial sponsors.”
In contrast, Blaha said the JUPITER research was well executed, but in the future, different measurements may need to be used to determine which healthy adults may benefit from statins, depending on whether the results of his research hold up in a clinical trial.
“Calcium is a newer technology,” Blaha said. “There’s never been a trial of statins where people have had their calcium measured.”
“I think we’re ready to move past C-reactive protein, or at least to move toward calcium,” he added.
The Johns Hopkins research was funded by a grant from the National Institutes of Health.