In November the American Heart Association released its shiny new guidelines for the management of cholesterol, and in the process set off a firestorm. Talk shows talked, pundits opined, and cardiologists postured. But in the center of it all there is an evidence base that offers a clear-eyed view. Do statins for healthy people save lives?
Despite assertions by the AHA and others, the research simply does not support the use of statins in low-risk patients. Now go tell your friends.
In November the American Heart Association released its shiny new guidelines for the management of cholesterol, and in the process set off a firestorm. Talk shows talked, pundits opined, and cardiologists postured. But in the center of it all there is an evidence base that offers a clear-eyed view. Do statins for healthy people save lives?
Why should emergency physicians tune in to the statin debate? Atorvastatin is the best selling drug of all time, and statins are the best selling class. The question of whether statins work is therefore central to the legitimacy of the medical sciences. In addition there’s an excellent chance that you, or one of your first degree relatives, has been prescribed a statin. And finally, gifted cocktail party goers (read: you EPs) always take pride in knowing more than anyone about the latest medical scandal. Here’s your chance.
There is general consensus among the scientific community that statins lead to worthwhile benefits among those at high risk of cardiovascular events (though half of patients in surveys, when informed of the actual benefits and harms, decide against statins). There is, however, considerable controversy in the scientific community about statins for healthy people, those at a less than 20% risk of heart attack, stroke, or death in the next 10 years.
The Numbers Needed to Treat for preventing a heart attack and stroke in low risk people taking a statin for five years are estimated at 60 and 268, respectively. The Number Needed to Harm for getting diabetes due to a statin is estimated at about 1 in 50. In other words it may be as or more likely that a statin would cause diabetes, a chronic and life-altering condition, than prevent a one-time nonfatal heart attack.
With this unattractive balance of harms and benefits, why would anyone healthy take a statin? The answer is to live longer, which is where the heart of the controversy lies. If statins do extend life in healthy people, it seems reasonable to believe that there may be a public health benefit to expanding statin use—something the new AHA guidelines recommend.
So, do statins save lives? Recent publications, including by the Cochrane Collaboration (1) and in the Journal of the American Medical Association (by the same authors, reporting the same data) (2), conclude that indeed low risk people die less often if they take a statin. Unfortunately, however, the case is not closed. This claim, it turns out, is almost entirely dependent on one publication, the single most important analysis of this critical question, because it a) had the largest number of relevant study subjects (134000), and b) performed an individual patient-level analysis, which allowed the authors to examine low risk patients separately from the others. The paper in question was published in the Lancet in 2012 (3), and the results are remarkable. Most of the paper examines outcomes other than mortality, which are of limited interest to those sniffing out the controversy. In webfigure 9 (an online supplement at the bottom of the Lancet article’s webpage), however, is a shockingly simple answer to whether or not statins have been shown to reduce mortality in low risk patients. The answer is ‘no’.
For 5 out of the 6 lowest risk groups there is no statistical mortality benefit to statins compared to placebos (and in the 6th group the benefit is borderline). This holds true whether the subjects had a history of vascular disease or not. In other words, whether a patient has had vascular events or problems in the past doesn’t seem to matter. For the nearly 50,000 subjects at a less than 20% risk according to their risk score at study entry, mortality was not reduced by taking a statin.
Could it be this simple? Apparently. Consider the problem solved, the question answered. And healthy people being offered statins should be told this. Though, of course, most are not. How could they be when most physicians don’t know? But as a physician and prescriber, as the family’s source of medical knowledge, and as a master cocktail conversationalist, you may find this information useful.
References
1. Taylor F, Ward K, Macedo AF et al. ‘Statins for the Primary Prevention of Cardiovascular Disease.’ Cochrane Database Syst Rev 2013;1(1):CD004816 doi:10.1002/14651858.CD14004816.pub14651855
2. Taylor FC, Huffman M, Ebrahim S ‘Statin Therapy for Primary Prevention of Cardiovascular Disease’ JAMA Clinical Evidence Synopsis, JAMA Dec 11, 2013, 310:22, 2451.
3. Mihaylova B, Emberson J Blackwell L et al: Cholesterol Treatment Trialists’ (CTT) Collaborators. The Effects of Lowering LDL cholesterol with statin therapy in people at low risk of vascular disease: meta-analysis of individual data from 27 randomised trials. Lancet. 2012:380 (9841):581.
David H. Newman, MD
Author of Hippocrates’ Shadow: Secrets From The House Of Medicine
1 Comment
You say, “Despite assertions by the AHA and others, the research simply does not support the use of statins in low-risk patients. Now go tell your friends.”
Well, you’re right, and it never did. I remember having this discussion with my own Primary Care Physician 9 years ago, when I personally opted not to take a statin. It was true then, and still is now. It wasn’t a secret, but wasn’t shouted at the hill tops either.
What it tells you, is how much our judgment is clouded by drug companies, how good they are at doing their jobs, and that despite “evidence based medicine,” how skeptical we need to be of “the evidence” and even more so, its interpretation.