By Ed Edelson
TUESDAY, Jan. 13 (HealthDay News) -- If doctors start taking results of a recent drug company-sponsored trial seriously, 11 million more older Americans might be taking cholesterol-lowering statin medications, experts say.
Results from the JUPITER trial were first reported in November 2008. The study was cut short, because treatment with Crestor (rosuvastatin) -- the statin marketed by AstraZeneca, sponsor of the trial -- was found to reduce heart attack and stroke by 44 percent among participants who had normal levels of "bad" LDL cholesterol but elevated levels of an inflammatory marker called C-reactive protein (CRP).
If that finding becomes an important element in medical practice, researchers at Yale University estimated that the use of statins will be expanded widely.
They published their findings Jan. 13 in the journal Circulation: Cardiovascular Quality and Outcomes.
High levels of LDL cholesterol can lead to high blood pressure and heart woes, and today about 33.5 million older Americans (men 50 and older, women 60 and older) now either take a statin drug or should be taking one to lower their cholesterol levels, the report said. Statins include blockbuster medications such as Crestor, Lipitor, Pravachol and Zocor.
But what about people who have normal levels of LDL cholesterol, but higher concentrations of the inflammatory marker CRP? Adding those people into the mix would greatly expand the pool of potential statin users, the researchers said.
"Based on our analysis, more than 44.7 million older Americans might have an indication for statin therapy when you consider those who already meet current guidelines for statin therapy and those who might be eligible based on the criteria proposed in JUPITER," lead author Dr. Erica S. Spatz, an internist and fellow in the Robert Wood Johnson Clinical Scholars program at Yale, said in an American Heart Association (AHA) news release.
But while the new analysis "provides important information about the size of the population that might be affected if the JUPITER findings get into clinical practice, it raises more question than it answers," Spatz added. "There are questions about CRP and questions about whether it would be cost-effective to treat that many people with statins."
Current guidelines do not include CRP levels as indicators for statin treatment, noted Dr. Timothy J. Gardner, AHA president and medical director of the Center for Heart and Vascular Health at the Christiana Health Care System in Delaware.
The guidelines of the U.S. Heart, Lung, and Blood Institute regarding statin use probably will be updated "in the next year or so," Gardner said, and the JUPITER results "will be carefully considered" when they are.
"Information from the JUPITER trial has certainly alerted us to the possibility that measuring CRP as a biomarker might indicate that some older patients might benefit from statin therapy who are not on it, because they have LDL levels in the normal range," Gardner said. "It particularly might be worth looking at older men and women who have other risk factors, such as obesity, high blood pressure and metabolic syndrome."
Metabolic syndrome is a constellation of risk factors that can include insulin resistance and elevated CRP levels in addition to high blood pressure and obesity.
Still, "most cardiologists do not use CRP levels, because they have not been conclusively established as a reliable indicator of risk," Gardner said.
"Because of the JUPITER trial, many are considering using it in older patients," he said. But the heart association has taken no stand on the issue, he said.
A physician must consider more than CRP and LDL levels when making a decision about statin treatment, said Dr. Suzanne Steinbaum, director of women and heart disease at Lenox Hill Hospital in New York City. High blood pressure and obesity, even at borderline levels, can tip the scale, she said.
"What we can glean from this kind of study is that patients we might consider to be at borderline risk, if they have inflammation, we should classify them at a higher risk factor status, she said. "If there is evidence of inflammation, I will start them on a statin."