Statins and ezetimibe and biomarkers

Now we have to get into a discussion of the end-points that the researchers chose. Rather than using "hard end-points" such as changes in death rates from heart disease, or changes in heart attack and stroke rates, this and many other studies use surrogates for these end-points; the surrogates are "biomarkers." Some of these biomarkers are well-established, and are generally assumed to be valid substitutes for measuring heart attack rates or death rates: for example, lowering LDL-cholesterol has been used as an endpoint in many trials. Using radiologic images to assess disease progression is another biomarker. And one that, in hindsight, may not have been appropriate to assess any difference in the effectiveness of the drugs evaluated in this trial.

And the patients chosen may not have been the best group to study: many had been on statins for years, which may have altered the ability of their IMT to change during the study.

So, how has the scientific community reacted? The ACC pointed out in their statement on the ENHANCE Trial: "There should no be reason for patients to panic. The difference in IMT changes between the simvastatin group and the Vytorin group was 0.006 mm vs. 0.011 mm... Conclusions should not be made until the three large clinical-outcome trials are presented within the next two to three years. The ACC recommends that Zetia remain a reasonable option for patients who are currently on a high dose statin but have not reached their goal. The ACC also notes that Zetia is a reasonable option for patients who cannot tolerate statins or can only tolerate a low dose statin."

My advice: if you're on Vytorin or Zetia, and and your cholesterol levels have decreased appropriately, you should stay on them; there's no doubt that they can lower cholesterol, which is after all a widely-respected biomarker. One exception: if you have financial issues paying for these drugs, a switch to a generic statin might save money and perhaps have the same effectiveness. Talk it over with your physician.