The News About Vytorin Sounds Bad, but Don't Panic
Reading our FAQ won't lower your cholesterol, but it might do wonders for your heart rate.
Doctors are being besieged by calls from worried patients taking the cholesterol-lowering drug Vytorin. A 720-patient study released by its U.S. distributor, Merck/Schering-Plough, showed that the drug, a one-pill combination of the statin Zocor and the nonstatin Zetia, wasn't any better than the same dose of Zocor alone at keeping fatty plaque from building up in the arteries of the neck. If you're taking the drug, here's a quick look at what you need to know.
What should I make of news reports about more deaths and heart attacks in patients using Vytorin?
The number of such events was tiny and the differences meaningless, say the experts we consulted—two deaths compared to with one and three nonfatal heart attacks compared with to two. The study was far too small for any conclusions about heart events.
I don't need to stop taking Vytorin, then?
No, says Roger Blumenthal, a Johns Hopkins cardiologist and chair of the American College of Cardiology's prevention committee. Besides the trivial number of cardiovascular problems, he says, there was no indication of liver-function problems, a sign of trouble.
Why was Vytorin supposed to work better than Zocor alone?
In clinical trials that led to Vytorin's approval in 2004, the combined one-two punch of a statin, which inhibits cholesterol production in the liver, and Zetia, which keeps the substance from being absorbed in the intestine, knocked down the level of LDL cholesterol about 20 percent more than Zocor could by itself. That was the case in this study, too: the average LDL in the Vytorin group dropped by 58 percent compared towith 41 percent in the Zocor group. Moreover, long-term studies of Zocor and the even-more-potent statin Lipitor have shown that radically lower LDL levels pays off in reduced cardiovascular events.
What was it that Vytorin failed to do?
As fatty plaque builds up, it increases the thickness of the walls of the carotid arteries in the neck; progressive thickening is a good indicator of cardiovascular risk. Slowing or reversing the process demonstrates a drug's effectiveness. On average, the thickness in both groups increased (very slightly) during the two-year study.
What was Vytorin's problem?
It's a mystery. But the patients in the study weren't exactly typical—all had extremely high LDL levels of above 300 because of a genetic condition. Whether the results of the study are relevant to individuals with more-typical LDL isn't clear.
If I'm not now taking Vytorin, is there a reason not to start?
Many experts feel that Vytorin shouldn't be anyone's first cholesterol-lowering drug. The clinical benefits and side effects of Zocor are well known, while Zetia—the nonstatin part of Vytorin—hasn't had time to amass a similar résumé. "We've always said you start with a statin and add on if a statin doesn't work well enough," says Mark Abramowicz, editor of the Medical Letter, an authoritative advisory publication for physicians. (It will issue a special brief on Vytorin next week.) Vytorin is also an option for those on a high-dose statin who experience muscle or joint discomfort, weakness, or pain. The dose of Zocor in Vytorin can be as low as 10 milligrams, one eighth of the maximum.
Is there anything else I should consider?
How about cost? Consumer Reports Best Buy Drugs, an information and education arm of Consumers Union, noted in a release on Monday that Vytorin is considerably more expensive than simvastatin, the generic version of Zocor now produced by several manufacturers. In November, a month's worth of Vytorin was priced at about $120 on average, while simvastatin was about $40 to $75, depending on dose. (And the copay for generics is lower in most healthcare plans than it is for brand-name drugs.) Simvastatin is also cheaper than Lipitor or Crestor, two newer brand-name statins, observes Steven Findlay, the project's managing editor.
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