Word: vytorin
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Dates: during 2000-2009
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After nearly two years of waiting, the results came out on Monday on the long-awaited heart drug Vytorin - and the news wasn't good. Vytorin's manufacturers, Merck and Schering-Plough, announced that while the drug reduced levels of LDL, or bad cholesterol, in a group of 750 patients, the medication, which has been on the market since 2004, had little effect on the buildup of plaque in the arteries, a harbinger of heart attack and stroke...
...studies have shown that statins can also lower inflammatory factors that can aggravate plaques, causing them to burst and block heart arteries, as well as reduce amounts of triglycerides, a particularly dangerous form of fat for the heart. "The bottom line is that we just don't know what Vytorin does, because we don't have the clinical trials," he says. "We know Vytorin blocks absorption of cholesterol. But what else does it block - something else in the diet that could be beneficial? We just don't understand fully how it works...
...extended delay in reporting the results of the Vytorin study - called ENHANCE - Schering-Plough spokesperson Lee Davies told TIME that it was due to the time involved in reading and interpreting the tens of thousands of images of the carotid arteries that the study generated - data that had been available since April 2006. The company's procrastination prompted much discussion among heart doctors and on Capitol Hill: At the end of 2007, the House Energy and Commerce Committee sent a letter to the two manufacturers asking for the findings - and noting that the end point of the study specified...
...even there, Vytorin failed to show much effect. Vytorin is actually the combination of two drugs - one of the early statin medications, simvastatin (also known as Zocor), made by Merck, and ezetimibe, or Zetia, made by Schering-Plough. Ezetimibe is the first cholesterol-lowering medication that works by blocking absorption of cholesterol in the gut, rather than regulating the fat's production in the liver, like other statins do. ENHANCE compared the effect of Vytorin to simvastatin alone, and showed little difference between the two medications when it came to plaque size in the arteries. Simvastatin came off patent...
ENHANCE may only be the opening salvo against Vytorin - three larger trials are currently under way to measure the drug's effect on heart attack and stroke - and many physicians are not optimistic. "Given these results, it's highly unlikely that those outcomes studies will show dramatic benefit for Vytorin," notes Dr. Raymond Gibbons of the Mayo Clinic, and past president of the American Heart Association...