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Study Reveals Disappointing Results from Popular Cholesterol Drug
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findingDulcinea Staff
On Jan. 14, Merck & Co. and Schering-Plough Corp. reported eagerly anticipated, but disappointing, results from a cholesterol-lowering drug study that was completed in 2006.
30-Second Summary
The companies had expected the study, called Enhance, to show that Vytorin, a combination of Zetia and Zocor, cleared plaque from arteries better than Zocor alone.
The study consisted of 720 patients and lasted for two-years. It found that Vytorin does not clear away plaque more effectively than Zocor alone.
In some cases, patients taking Vytorin had higher plaque accumulation in arteries; however, this could be due to chance or error considering the small sample size.
According to Matthew Herper of Forbes, the companies changed the main goal of their two-year study in November 2007, a year and nine months after it had been completed.
This change is considered out of the ordinary as goals are defined before a study and not changed after a study has been completed.
The change was the catalyst for a congressional investigation into the delay of the results.
Since the results were released, the two companies have seen their stock prices fall.
Five million people use Zetia and Vytorin worldwide, according to The New York Times. Approximately one million prescriptions are written for the drugs each week, and in 2007, their combined sales reached $5 billion.
The study consisted of 720 patients and lasted for two-years. It found that Vytorin does not clear away plaque more effectively than Zocor alone.
In some cases, patients taking Vytorin had higher plaque accumulation in arteries; however, this could be due to chance or error considering the small sample size.
According to Matthew Herper of Forbes, the companies changed the main goal of their two-year study in November 2007, a year and nine months after it had been completed.
This change is considered out of the ordinary as goals are defined before a study and not changed after a study has been completed.
The change was the catalyst for a congressional investigation into the delay of the results.
Since the results were released, the two companies have seen their stock prices fall.
Five million people use Zetia and Vytorin worldwide, according to The New York Times. Approximately one million prescriptions are written for the drugs each week, and in 2007, their combined sales reached $5 billion.
Headline Links: Study raises concerns about cholesterol drug
The New York Times reports that the Enhance study was originally completed in April 2006. It found that the cholesterol-lowering drug Vytorin, did not slow the growth of plaque in the arteries more effectively than Zocor alone. In fact, in some cases patients taking Vytorin had higher plaque accumulation.
Source: The New York Times (free registration may be required)
According to Matthew Herper of Forbes, the main goal of the Enhance study was changed in November 2007; this was after Merck and Schering-Plough missed several self-imposed deadlines. Bruce Psaty, a drug safety expert states, "You just don't change a primary endpoint in a major important trial partway through.”
Source: Forbes
The bottom line
Dr. Michael Davidson, who worked on some of the FDA trials of Vytorin and Zetia, thinks that despite the findings, some patients should continue to take the drugs. "We treat based [on] goals rather than [on] specific drugs," Dr. Davidson, director of preventive cardiology at the University of Chicago's Pritzker School of Medicine, told The Wall Street Journal, "That's the important message that is not changed by this trial."
Source: The Wall Street Journal
Background: Vioxx and the FDA
The U.S. Food and Drug Administration came under fire for another Merck drug in 2004. The FDA-approved Vioxx, a non-steroidal anti-inflammatory (NSAID) primarily used to treat arthritis, was pulled from the market after it was found to increase the risk of heart attack and stroke.
Source: Drugs.com
Opinions: Should patients use Zetia and Vytorin?
Contra
Dr. Scott K. Aberegg, an assistant professor of Medicine at Ohio State University in Columbus, writes on his Medical Evidence blog that the recent study should prompt people to consider boycotting ezitimibe, the class of cholesterol-lowering drug Zetia falls in, until “improved clinically meaningful outcomes can be shown with this agent in properly designed and conducted trials with sufficient transparency.” Aberegg describes his blog as a discussion forum for medical professionals “interested in how clinical trials evidence is generated, disseminated, and incorporated into clinical practice.”
Source: Medical Evidence Blog
Pro
Lee Davies, a spokesman for Schering-Plough, told WebMD that "the implications drawn from the findings in terms of clinical use seem out of proportion to what the trial was designed to demonstrate. One should keep in mind that while statins are the first-line therapy for most people, they are not enough for many people and are not appropriate for some. There is a need for viable alternatives, and Zetia and Vytorin have proven to be very effective for lowering LDL levels."
Source: Web MD
Reference Material: Good and bad cholesterol, types of cholesterol-lowering drugs and the Merck study
The Mayo Clinic explains that low-density lipoprotein, widely known as LDL, is the “bad” cholesterol, because it can accumulate on artery walls and potentially cause a heart attack or stroke. High-density lipoprotein, or HDL, is the “good” cholesterol, because it helps prevent arterial blockage.
Source: Mayo Clinic
The American Heart Association provides information on cholesterol-lowering drugs including statins, selective cholesterol absorption inhibitors (Zetia), resins, fibrates and niacin.
Source: The American Heart Association
The Merck Web site offers the company's response to the findings with data from the study.
Source: The official Web site of Merck & Co., Inc.
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