Widening statin use among a larger population of patients could cost-effectively prevent incidence of heart attack and stroke, and screening patients for a high sensitivity C-reactive protein could help identify patients who would best benefit from statin treatment, according to the results of a trial published online Sept. 27 in Circulation.
"Many MIs and strokes occur in individuals with low-density lipoprotein cholesterol levels below recommended treatment thresholds. High sensitivity C-reactive protein (hs-CRP) testing has been advocated to identify low- and intermediate-risk individuals who may benefit from statin therapy," the authors wrote.
Current ATP-III clinical guidelines recommend that statin therapy be used in high-risk individuals who are at a 20 percent or more risk of a cardiovascular event within the next 10 years. However, r esults of the JUPITER trial had shown that millions more patients, even with low cholesterol, could benefit from the use of statins.
“If statins are really as safe and effective as they appear to be, broadening the indications for statin therapy would be an effective and cost-effective strategy," said the study’s senior author Mark Hlatky, MD, of Stanford University Medical Center, Stanford, Calif. "But under different assumptions, targeted CRP screening would be a reasonable approach.”
During the study, lead investigator Keane K. Lee, MD, and colleagues used a decision analytic Markov model to compare current practice guidelines, hsCRP screening in patient not indicated for statin use under the current guidelines and statin therapy at certain risk thresholds without CRP testing.
According to the authors, "Increasing the cost of statin medication would make all three strategies less cost-effective." They found that a statin that cost $3.85 per day would make the ATP-III guidelines the most cost-effective strategy at a $50,000-per-quality-of-life-years (QALYs) willingness-to-pay threshold. The authors also noted that hsCRP screening was the optimal strategy when statins cost between $2 and $3 per day; however, risk-based treatment without CRP screening was preferred for most of the risk groups when statins cost less than $2 per day.
"Initiation of statin treatment at lower risk levels without CRP testing would further improve clinical outcomes at acceptable cost, making it the optimally cost-effective strategy in our analysis," the researchers wrote.
Additionally, the researchers noted that administering a statin at the age of 55, even in men with no risk factors, would be the optimal strategy of treatment. But, the researchers found that the aforementioned optimal strategy changed if assumptions in the models were offered.
For patients with normal CRP levels who saw little or no benefit from statin therapy, CRP screening could be the optimal strategy. Additionally, they said that if the benefit of the use of statins is only slightly higher than what it should be, then statin therapy is not reasonable in low-risk individuals and following the current recommendations would be the best, most cost-effective strategy.
"This is not a slam-dunk decision in terms of: You should take people at low risk and put them all on treatment," said Hlatky. "If you run the model and change the assumptions even a little bit, you get a different answer. Our model shows that we need better data to be confident about the best approach to drug treatment of lower-risk individuals."
The authors said that further trials that evaluate whether statins work as well in low-risk patients or just high-risk patients are needed.
The study’s co-author Douglas Owens, MD, offered that it could be beneficial to understand whether high CRP levels could do more than identify people at risk of heart disease development and identify those at a lower risk of heart attack or stroke when administered statins.
"Ideally, a marker would tell us who will benefit from drug treatment and who will not," said Hlatky. "If a test could give us that information, it would be very cost-effective. But there's not good evidence yet that CRP, or any other test, works that well."
The authors noted that a National Heart, Lung and Blood Institute working group is working to update the clinical guidelines and recommendations for statin therapy.
"Statin treatment of intermediate- to low-risk men and women at specific predicted cardiovascular risk thresholds without hsCRP testing appears to be the optimal primary prevention