Jan. 13, 2009 -- Eight out of 10 middle-aged and older Americans may benefit from treatment with cholesterol-lowering statin drugs, a new analysis suggests.
Researchers concluded that 11 million older people who are not considered candidates for treatment with statins under existing guidelines would qualify for treatment if guidelines were changed to reflect the findings of a landmark trial published last November.
Known as the JUPITER trial, that study was designed to determine if adults with normal-to-low cholesterol would benefit from statin treatment.
All the participants had elevated levels of high-sensitivity C-reactive protein (hsCRP) -- a marker of inflammation that has been linked to heart disease.
The trial was stopped early after the benefits of the therapy became clear.
Over an average of two years of treatment, participants who took the statin Crestor had half as many heart attacks, strokes, and deaths from cardiovascular causes as participants randomly assigned to receive a placebo.
Statins: Who Benefits?
In the newly reported analysis, researchers used a nationally representative health database to estimate the number of people who would be candidates for treatment with statins if current guidelines were changed to include people with normal low-density lipoprotein (LDL) cholesterol levels but elevated hsCRP.
Using data from the CDC's 1999-2004 National Health and Nutrition Examination Survey (NHANES), they concluded that:
- 33.5 million (25%) American men 50 and older and women 60 and older take a statin.
- Based on existing guidelines, an additional 33% middle-aged and elderly people should be taking statins but are not.
- 11 million more middle-aged and older Americans (19%) would be considered candidates for statin therapy if guidelines were changed to include adults with elevated hsCRP.
"We are talking about millions of additional people who might benefit from treatment with statins, but there are many questions that remain unanswered," says researcher Erica S. Spatz, MD, of the Robert Wood Johnson Clinical Scholars Program at Yale University, which funded the analysis.
It is not clear, for example, if the health benefits derived from treating millions of additional people justify the costs.
And the JUPITER trial also raised important questions about the role of hsCRP testing for determining cardiovascular risk.
Spatz points out that most of the people in the trial who were identified as new candidates for treatment with statins shared many of the characteristics of people who qualify for treatment under existing guidelines.
Who Should Be Tested?
Compared to people with no indication for treatment, the JUPITER patients were more likely to be female, elderly, obese, and have high blood pressure.
They were also more likely to have a collection of risk factors linked to diabetes and heart disease known as metabolic syndrome.
American Heart Association (AHA) President Timothy Gardner, MD, says identifying chronic inflammation in patients with these risk factors may be beneficial.
Gardner is medical director of the Center for Vascular Health at Christiana Care in Wilmington, Del.
"I think the idea of measuring the C-reactive protein biomarker in some patients is warranted, and I would probably start with patients who are obese, hypertensive, or have metabolic syndrome," he tells WebMD.
While the new analysis suggests that the vast majority of elderly people in the U.S. would benefit from treatment with statins, Gardner urges caution.
"Some physicians might favor putting all older patients on statins, but it is important to remember that no drug is without potential risks," he says. "The challenge in front of us is identifying those patients for whom this treatment is cost-effective and appropriate."
Spatz did not participate in the JUPITER trial, which was funded by Crestor manufacturer AstraZeneca. Her study appears today in the AHA journal Circulation: Cardiovascular Quality and Outcomes.