Three studies presented at the recent American Heart Association annual meeting deserve our attention. The first studied Vytorin (10mg Zetia and 40mg Simvastatin) vs 40mg Simvastatin alone in patients with known coronary artery disease. States the study website: “Vytorin significantly reduced CV outcomes more than Simvastatin alone” in this group. Over 7 years there was a 6% reduction in CV endpoints compared to statins, which is approximately (by our calculations) 3-4 additional people who will benefit out of 1000 who take Vytorin rather than Simvastatin. The study is not yet published or peer reviewed and stands in contrast to virtual every other study that has demonstrated two outcomes: that Zetia has no impact on heart disease, and that lower cholesterol without a statin has no relevance. That has not stopped the study’s author Dr. Eugene Braunwald of Harvard, fellow academic cardiologists, Merk, and the press from stating that unequivocally we now know that lowering LDL cholesterol to very low levels is beneficial. Says the New York Times: “The new study indicates that the crucial factor is LDL, and the lower the level the better….Now, Dr. Braunwald said, the arguments over cholesterol lowering should be settled.” Settled? By one study with a 3/1000 improvement in outcome, that stands in contrast to virtually every study that preceded it? Again, the cardiology community wants us to be number obsessed. Despite recent guideline recommendations based on a large quantity of evidence suggesting there is no value to measuring LDL or worrying about how much we lower it, this community demands that we pay close attention to LDL cholesterol and push it as low as possible; it is their gospel, and this new study is their sacred proof. Perhaps such logic will be proven to be correct, but we have heard it all before so many times, and each time it has been effectively debunked. Now one study is supposed to wake us all up? It is amazing how much cardiologists are obsessed with LDL!
Two other studies at the AHA meeting also furthered the cause of the cholesterol advocates, although these utilized statins alone. A study of Scottish men with high cholesterol who took Pravastatin for 5 years had a drop in heart attack (20/1000) and death (7/1000) later in their lives. Said one article: “This is the first study to show conclusively that pharmacological intervention to reduce cholesterol levels in otherwise healthy men with hypercholesterolemia can lead to reduction in mortality.” The words “first study” and “conclusively” should hardly be in the same sentence, since other studies have been far less sanguine about treating healthy people with statins, so this is hardly conclusive proof that statins should be taken by everyone. Still, that is what the press would lead us to believe; statins perhaps need to be used by everyone! A third study looked a small subgroup of elderly (defined as age 65-70)who took simvastatin and found a large relative risk drop (over 30%) in death and heart attack endpoints. Again, this unpublished work without any data on absolute risk reduction sounds like other similar statin studies that show a very modest reduction of endpoints in the elderly in absolute terms, but that did not stop some academics from stating that we should not be withholding life saving treatment from the elderly by denying them statins. I have seen what statins can do to the elderly, and the population in this study was hardly old, so it may be best not to leap to such definitive conclusions. Still, as all three studies indicate, although the role of cholesterol lowering and statin use remains controversial and patient-specific, the cardiology community will have us all believe that frequent labs tests, drug use, and dramatic LDL lowering is a gospel to which all of us must adhere. Well, until the next study comes out, in which case they will inevitably have to backslide again.