One in three American adults have high LDL cholesterol, a major risk factor for heart disease, which is the leading cause of death in the United States. A new study by researchers at the Harvard T.H. Chan School of Public Health (HSPH) finds that statins, a class of prescription drug that helps lower cholesterol, should be administered—from a cost-effectiveness perspective—to almost half of American adults aged 40 to 75.
Using a computer-generated simulation model that incorporated real-world data, the study concluded that the benefits of prescribing a statin for people with a 7.5 percent or greater risk of heart attack or stroke over a 10-year period outweigh the costs; 48 percent of the adult population in the United States falls into this risk category.
The threshold proposed by the researchers is not new. In fact, it can be found in the current guidelines for statin treatment issued by the American College of Cardiology and the American Heart Association in 2013. These recommendations have been surrounded by controversy since they appeared: critics have argued that they overestimate risk, and that following them could expose millions of adults to unnecessary treatment.
To test whether the guidelines make financial sense, at least, the researchers performed a cost-effectiveness analysis to determine the optimal value for the 10-year heart-disease-risk threshold. They found that not only do the current guidelines have an acceptable cost-effectiveness profile, but that prescribing statins for those with only a 3 percent or greater risk—which translates into 67 percent of U.S. adults—would be optimal, averting an additional 161,560 cardiovascular-disease events. “I hope it helps to calm down the controversy, or at least inform the debate around the guidelines,” said Ankur Pandya, assistant professor of health decision science at HSPH and lead author of the study.
Statins may have side effects such as muscle pain, but the effects are relatively mild even compared to those of some over-the-counter drugs such as aspirin, according to Pandya. There is also a small but significant risk of statin-induced diabetes, but senior author Thomas Gaziano, an assistant professor at Harvard Medical School, said the benefits of administering statins would still outweigh the costs, considering that statins can help to reduce the risk of heart disease by 25 percent or more.
Would people on statins feel less guilty about eating an extra ice cream or skipping the gym? Gaziano called that unlikely. People who are committed to taking a statin pill every day, he said, tend to be genuinely concerned about their health, and less prone to make unhealthy lifestyle choices.
Though cost-effectiveness analysis—which compares the relative costs and outcomes of several courses of action—has existed for several decades, it has recently seen an upswing of attention from policymakers and health experts, Pandya said. Given a national movement toward evidence-based, accountable care and the linking of physician performance with actual results, guidelines justified by such analyses may become more influential in the future.
“Guidelines give us some guidance on what’s best for us, but there is always a personal discussion needed between the patient and the provider on whether taking the medication is a good choice,” Gaziano said. “We are just providing information…to make people recognize this is a safe decision.”
“Cost-effectiveness of 10-Year Risk Thresholds for Initiation of Statin Therapy for Primary Prevention of Cardiovascular Disease” appeared online today in the Journal of the American Medical Association.
