An Old/New Alternative to Statins for High-Risk Patients: Lessons for the “Experts?”

ucm293331A very interesting article written by Gina Kolata and entitled, “Study finds alternative to statins in preventing heart attacks and strokes,” was published on-line in today’s NYT.  I found the article interesting for two reasons: first, it summarized results from a study reported today at the annual meeting of the American Heart Association that showed great benefit from treating high-risk patients with, a cholesterol-lowering drug called ezetimibe (brand name Zetia).  Second, it put to shame, earlier reports showing that  the drug was not beneficial, leading to mass exodus from treatment with the drug a number of years ago.

Let Me Back Up a Bit

The data are very clear that if people at high-risk for heart attacks and strokes are treated with one of the “statin” drugs, their risk is significantly decreased.  Statins lower LDL-cholesterol (the “bad” cholesterol) by inhibiting synthesis of LDL-cholesterol.  Another drug, ezetimibe, is known to lower LDL-cholesterol by blocking absorption of cholesterol from the gut.  It was reasoned that combining  ezetimibe with a statin would provide “extra” benefit in preventing cardiovascular diseases.  The combination drug was called Vytorin and the drug was widely prescribed.  But, in 2006, a study showed that the drug did not decrease the amount of carotid artery blockage, and on that basis all the “experts” recommended that Vytorin no longer be used.  Now, all of a sudden we have new data showing that the combination drug not only lowered LDL-cholesterol more than a statin alone, but that it also significantly decreased risk for adverse cardiovascular outcomes (like heart attacks, strokes, deaths, etc) more than the statin alone.  Other recent studies seem to support these findings.  But, what we don’t know is whether ezetimibe alone is as effective as a statin in decreasing cardiovascular risk.  In my opinion, this is the critical question, because more than a few patients with heart disease and at high-risk for heart disease cannot tolerate statins because of side-effects such as muscle pain or liver disease.  In particular, I have a number of patients with diabetes who have high LDL-cholesterol levels who cannot tolerate statins and who would benefit from a drug that could decrease their risks for the development of cardiovascular diseases.

The Bottom Line

I am still trying to figure out what the lesson or lessons are that we have learned from the ezetimibe story and how many more lessons are still to be learned.  At this point, I think one important lesson is that the “experts” sometimes jump to incorrect conclusions based on this or that study and make what turn out to be inappropriate recommendations for patient care.  We the public (and that includes docs too) need to be wary of  expert opinion and guidelines from expert groups unless their recommendations are well supported by the data.  In this instance, surrogate data (carotid artery plaque measurements) are nice, but can’t compete with “hard” data such as deaths, heart attacks, strokes, as such.  I do highly recommend you check out the article if only to see how nice it is to see the “experts” squirm.  One other thing, we will need to reconcile these new data with lots of other data showing that cholesterol consumption probably plays a very small role in risks for the development of cardiovascular diseases.  For example, it is hard finding any data that show eating eggs in moderation has any effect on risks for the development of cardiovascular diseases (on average, one egg contains 200 mg of cholesterol with the current recommended total daily allowance of cholesterol set at 300 mg).  In addition, many people who develop cardiovascular diseases thought to be caused by elevated cholesterol levels, do not have elevated cholesterol levels.  We still have a lot to learn.

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