Later On

A blog written for those whose interests more or less match mine.

On Zetia (or Vytorin)

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I did ask my endocrinologist about my taking Zetia in combination with Zocor (simvastatin). He had an answer prepared:

The ENHANCE Study is a medical trial study done in 720 patients with Heterozygous Familial Hypercholesterolemia (HeFH). This is a relatively rare form of disease in which cholesterol levels are extremely high due to LDL-cholesterol (“Bad” cholesterol) receptor abnormalities. These patients have very high rates of atherosclerosis leading to heart disease and strokes. This study was conducted by the manufacturers of Zetia (Merck and Schering-Plough Pharmaceuticals) in an attempt to show that atherosclerotic plaque buildup (cholesterol, fats, and calcium) on the inside of arteries
in the neck would be slowed down in these high-risk patients who took Zetia + simvastatin as opposed to simvastatin alone after a period of 2 years.

Merck and Schering-Plough did the study and then sat on the results without publishing them for 20 months. The results were finally released January 14, 2008, and showed a negative result (there was no difference in the 2 study groups of patients). There was no evidence the patients taking the Zetia +_ simvastatin had any adverse outcomes or side effects from taking the Zetia. Their cholesterol levels in fact declined MORE than those of the patients who didn’t take the Zetia. They just didn’t do any better with regard to the primary endpoint of the study (atherosclerotic plaque buildup on the inside of arteries in the neck was NOT slowed down). Now there are calls from some physicians to stop prescribing Zetia for patients with hypercholesterolemia because they interpret this study to mean that Zetia is ineffective in reducing the risk of coronary artery disease and stroke.

My opinion on this is that at the moment we do not have enough good information to tell us that Zetia really is ineffective. My conclusion is that for all the patients currently taking Zetia or Vytorin, they should continue taking it. The reasons for this include the following:

1. The group of patients in the ENHANCE study is a uniform group of people with a rare disorder, that probably is NOT applicable to the general population. Their cholesterol levels were NEVER brought down to GOAL levels in either the study group of patients or the control group of patients. The study was NOT designed to look at outcomes such as heart attack or stroke, and it should not be surprising that we did not see differences in those outcomes. It is not clear that the study primary endpoint (vessel plaque buildup) is the best moraker for progression of atherosclerosis in this group of patients.

2. Zetia DID  in fact lower cholesterol levels significantly further in those patients in the study who took it. This is in keeping with Zetia’s mechanism of action and other studies of its action. What didn’t happen (and what the ENHANCE study was NOT designed to measure) was a difference in heart attack or stroke outcomes.

3. Our global knowledge of cholesterol problems and ahtherosclerosis supports the notion that lowering cholesterol levels will reduce the risk of heart attack and stroke. Unless that fundamental relationship is wrong, lowering the cholesterol level with drugs such as Zetia will in fact, given the proper study circumstances, show a decreased risk for stroke and heart attack over time. Zetia was approved by the FDA because in fact it does lower cholesterol levels effectively.

4. There are several other much larger studies currently underway that ARE testing Zetia with regard to heart attack and stroke outcomes. These studies should give us a much better indication of whether Zetia will reduce heart attack and stroke as we all up until this point have presumed it will. It makes good sense to wait at least until these new studies are published in the next 1-2 years before abandoning Zetia.

5. At this point in time, if we were just to abandon the use of Zetia, we would have no drug to replace it. Almost all patients who are taking Zetia are already taking a statin drug (or are totally intolerant of statin drugs and can’t take them at all) and are not at lipid level GOALs. If we stop using Zetia, those patients would never be able to get to their lipid level goals. And we know that unless we get patients to lipid level goals, that their burden of atherosclerotic plaque will continnue to rise.

The fact that Merck and Schering-Plough have suppressed the publication of this information for 20 months while they continue to make several BILLION dollars annually on Zetia is reprehensible. The system of drug approval, drug supervision, and drug studies in the United States needs reform. Those issues, however, should not taint a careful, balanced decision-making process about the real long-term usefulness of this medication. We need free and timely access to more information as soon as it becomes available.

Written by Leisureguy

24 January 2008 at 11:20 am

Posted in Daily life, Medical

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