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Study Casts Doubt on Cholesterol Drug Vytorin

Critics claim drug makers delayed releasing bad news

January 14, 2008    Spanish

Vytorin • Doctors Warned About Vytorin • Study Casts Doubt on Cholesterol Drug Vytorin • The Vytorin Study: A Doctor's Advice --- Complaints • Consumer Complaints

Bad news for consumers with high cholesterol levels: A long-delayed study shows the expensive new drug Vytorin had no benefit on the buildup of artery plaque over the older drug Zocor and could even put users at greater risk, even though Vytorin cut bad cholesterol 40% more.

Patients on Vytorin actually had more heart attacks, cardiovascular deaths and heart procedures than those who got Zocor, although researchers said the differences were small and could be due to chance.

In addition, patients on Vytorin ended the study with slightly more plaque in their arteries, a result that could also be due to chance.

Critics were quick to pounce. Sidney Wolfe, M.D., director of Public Citizen’s Health Research Group, said drug makers Merck and Schering-Plough and the U.S. Food and Drug Administration (FDA) lagged in warning the public about the drugs' risks.

"We first warned against using Vytorin, a combination of Zetia and the cholesterol drug Zocor (now generically available as simvastatin), in December 2004 on our Web site, WorstPills.org," Wolfe said.

"At the time, we said the FDA's own pharmacology reviewer recommended against approval of Vytorin, warning that tests showed serious toxicity in laboratory animals, regardless of how small of an amount of this combination drug was used.

Wolfe said the delays in releasing the study results were suspicious.

"It is disturbing that the companies completed the trial in April 2006 but found excuse after excuse not to release the unfavorable results to the public until today," he said.

Wolfe noted that the FDA's own pharmacology reviewer recommended against approval of Vytorin, warning that tests showed serious toxicity in laboratory animals, regardless of how small an amount of the drug was used.

"Now, a clinical trial by Merck and Schering-Plough adds to our concerns. It is disturbing that the companies completed the trial in April 2006 but found excuse after excuse not to release the unfavorable results to the public until today," Wolfe said.

Despite the worse outcomes experienced by some patients in the trial, some physicians are likely to ignore the study, arguing that cholesterol is a better measure of a drug's effectiveness than the measurement of plaque buildup.

"Physicians should only use ... Vytorin as a last resort," Steven Nissen, head of cardiology at the Cleveland Clinic, said in a Forbes story. "It should not be used as a routine therapy for high cholesterol unless we see some additional evidence of benefit."

The Vytorin Study: A Doctor's Advice

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