MELISSA BLOCK, host:
If you're among the many millions of people who take drugs to lower cholesterol, you may well be confused by the results of a study of the drugs Zetia and Vytorin. The manufacturers of those drugs have just released data showing that while they do significantly lower the level of bad cholesterol, or LDL, they do not prevent the buildup of plaque in the arteries. In fact, the drugs might increase that buildup.
So what's a patient to do?
Well, we've asked Dr. Stuart Seides to help sort through this. He's associate director of cardiology at the Washington Hospital Center.
Dr. Seides, are you getting a lot of calls from your patients today?
Dr. STUART SEIDES (Associate Director of Cardiology, Washington Hospital Center): Oh, yes. The way the press has picked up this information has created a lot of angst on the part of our patients who are taking either these drugs. And we've gotten a lot of calls today.
BLOCK: What are you telling your patients who call in?
Dr. SEIDES: Well, we're telling our patients, at least for the time being, to continue on the drugs that have been prescribed for them and that there is no reason for them to discontinue either Vytorin or Zetia.
BLOCK: Now, why use that? These new findings say that, yeah, the drugs do lower cholesterol but its benefit of reducing plaque in the arteries is not holding up. So why wouldn't you take something that might do both?
Dr. SEIDES: Well, I think it's important to remember that what we really care about when we use these drugs or any drugs that influence cholesterol or other risk factors is whether we are preventing heart attacks or strokes. What was looked at here was the thickness of the interior part of the carotid artery, which is a big artery in the neck. The study attempted to show that the use of Vytorin or Zetia as opposed to a statin drug, like Zocor, alone reduced the thickening of the arterial wall over a period of two years. That was not shown.
And so it is an interesting finding and suggests that simply by lowering cholesterol, you may not reduce the thickening of the walls on the carotid arteries, but it doesn't answer the issue of whether reducing the cholesterol further with Vytorin or Zetia compared to a statin alone will reduce events.
BLOCK: Was the expectation of these two drugs - Vytorin and Zetia - that they would help prevent heart attack strokes?
Dr. SEIDES: Well, the expectation I think is still, if they will. I do know that this study does not exclude that possibility. Remember that when we measure serum cholesterol, that too is a surrogate for clinical outcomes. We don't treat people to lower their cholesterol just to give them a better number. The number itself is a surrogate that we use to convince ourselves that we are reducing risk of clinical events.
BLOCK: So if you know there are drugs out there that do both - that lower cholesterol levels and would decrease the risk of, say, heart attack - why not just prescribe those?
Dr. SEIDES: Well, I think one should. I think with the exception of those people who cannot tolerate those drugs, the first line of treatment should be, and in my mind always has been, the prescription of a statin drug like Lipitor, Zocor, Crestor, Pravachol, Lescol - I think I hit all the ones that are marketed in the United States, and clearly that should be the first line of treatment.
However, in those patients who are getting a robust dose of statins, where you still have not achieved the cholesterol level that you think is optimal, I believe that adding Zetia still represents a very reasonable move on the part of the physician and patient. And we should have data on long-term outcomes. The real outcomes data are probably some time in the next, I would say, two to four years.
BLOCK: Two to four years could be a long time to wait.
Dr. SEIDES: It is a long time to wait. But unfortunately, one is talking is talking clinical outcomes, you need large numbers of patients studied over long periods of time to get statistical significant data.
BLOCK: Dr. Seides, if this study by the manufacturers, which are Merck and Schering-Plough, was completed about two years ago is just being released now after a lot of pressure from Congress and the media. Do you find that troubling?
Dr. SEIDES: Well, I think any time that one has a belief that data was available that could be used for the benefit of patients or the medical community and was not released promptly, that's always troubling. My understanding is that the manufacturers or sponsors of this study said that lots of time was required for data analysis. But obviously, there's a sneaking suspicion that because the outcome was not particularly favorable for the drug that they held it for as long as possible. I don't know what the truth is, but certainly it doesn't smell that good.
BLOCK: Dr. Seides, good to talk to you. Thanks very much.
Dr. SEIDES: Take care. Bye.
BLOCK: That's Dr. Stuart Seides. He's associate director of cardiology at the Washington Hospital Center.