TUCSON, Ariz., July 20, 2015 (GLOBE NEWSWIRE) -- Two studies published in the July 14 issue of JAMA support new guidelines that could nearly double the number of Americans taking statin drugs to prevent arteriosclerotic cardiovascular disease (ASCVD), noted the Washington Post.
"The studies should be scrutinized critically," stated AAPS executive director Jane M. Orient, M.D. "Putting nearly half the healthy population on a potent drug for 10 years in the hope of protecting perhaps 2 percent of them from a heart attack or stroke over that time period is risky medicine."
The guidelines released by American College of Cardiology/American Heart Association (ACA/AHA) in 2013 added the criterion of a 10-year risk of ASCVD exceeding 7.5 percent. The new studies address the change, which has been controversial. According to an accompanying editorial by Philip Greenland, M.D., and Michael S. Lauer, M.D., of Northwestern University, the results "suggest that the new risk threshold is likely to be reasonable and cost-effective; it may not even go far enough." The 7.5 percent threshold would increase the number of persons eligible for treatment from 43 million to 56 million and theoretically avert from 41,000 to 63,000 cardiac events or strokes over 10 years. Lowering the risk threshold to 3 percent could, they estimate, avert an additional 161,650 events.
"These studies do not actually look at the outcome of treating low-risk individuals for 10 years," Orient pointed out. "The benefits are calculated based on previous studies."
They do provide data on the numbers of cardiovascular events that occurred in individuals who were statin eligible or noneligible under 2004 or 2013 criteria.
The 3 percent threshold would be cost-effective at $150,000 per QALY (quality-adjusted life year), conclude authors of the second study. They adjusted for "the disutility associated with taking a pill daily, statin price, and the risk of statin-induced diabetes."
"Both studies ignore the other potential adverse events from blocking one of the body's most important metabolic pathways," stated Orient. "These include premature aging, damage to muscle, liver damage, heart failure, and memory loss and other cognitive effects."
The studies also take as dogma that statin benefits come from their cholesterol lowering effects, another assumption that has been challenged, she noted.
A "Viewpoint" article in the same issue of JAMA states that the ACA/AHA predictive modeling approach will be used in Medicare "Payment for Prevention." This will encourage doctors to treat more aggressively, Orient observes.
The Association of American Physicians and Surgeons (AAPS) is a national organization representing physicians in all specialties, founded in 1943 to preserve private medicine and the patient-physician relationship.