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After study review, FDA says patients should not stop taking cholesterol-lowering drugs.

By jeremyc | January 9, 2009

 The AP (1/9, Johnson) reports, “The Food and Drug Administration (FDA) said Thursday patients should not stop taking Vytorin (ezetimibe and simvastatin) or other cholesterol-lowering drugs, based on its just-completed review of a controversial study that hammered Vytorin sales.” In January 2008, “initial results of a study called ENHANCE showed Vytorin was no better than Zocor (simvastatin) at reducing plaque buildup in neck arteries — indicating Zetia (ezetimibe) gave no added benefit over Zocor.”

        In a statement posted on the FDA’s website, the agency said that “following two years of treatment…carotid artery thickness increased by 0.011 mm (millimeters) in the Vytorin group and by 0.006 mm in the simvastatin group,” HealthDay (1/8, Reinberg) added. “The difference in the changes in carotid artery thickness between the two groups was not statistically significant.” The statement noted that “the difference in the reductions in [low-density lipoprotein] cholesterol between the two groups was statistically significant.” The agency “reiterated its position that ‘elevated amounts of…(LDL)…are a risk factor for cardiovascular diseases such as heart attack, stroke, and sudden death, and that lowering LDL cholesterol reduces the risk of these diseases.”

        In the Wall Street Journal (1/8) Health Blog, Jonathan D. Rockoff wrote that “the drug’s marketers, Schering-Plough and Merck, said they were ‘pleased’ with the announcement. But this doesn’t mean the companies are out of the woods just yet.” The agency “must also review another study, called Seas (Simvastatin and Ezetimibe in Aortic Stenosis), that suggested Vytorin increased the risk of cancer, although that finding has been seriously disputed. A third study, Improve-It (IMProved Reduction of Outcomes: Vytorin Efficacy International Trial), is looking at whether Vytorin actually reduces heart attacks, strokes, and death.” In addition, “federal and state prosecutors are probing whether the companies improperly marketed Vytorin.” Bloomberg News (1/9, Pettypiece), Dow Jones Newswires (1/9, Favole, Dooren), MedPage Today (1/8, Peck), and MarketWatch (1/9, Witkowski) also cover the story.

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