Word: cholesterol
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Researchers have discovered seven new genes that affect cholesterol levels in humans and that may influence the risk of heart disease...
...becoming clear, for example, that statins, an $18 billion market in the U.S., may lower the risk of heart disease by doing more than just lowering cholesterol - 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...
...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...
...could such a drug be approved in the first place? The Food and Drug Administration would only say that it is "evaluating the available data related to the ENHANCE study." That would include the "food and family" advertisements for Vytorin, which claim that the drugs attack high cholesterol levels, whether they come from your diet or from your genes, or some combination of both. Davies says the company has made "no determination at this time" on the fate of that campaign. But it should give the FDA good reason to evaluate how it approves future medications in this class...
...meantime, doctors are likely to dial back on their use of Vytorin. "If they aren't getting to the target goal [cholesterol level] with generic simvastatin, then because this study is raising questions I think a lot of physicians will think about switching to higher doses of drugs like Lipitor or Crestor before going to Vytorin," says Blumenthal. At least the commercials got one thing right - your risk of heart disease does depend on the food you eat and the genes you inherit. It's just that Vytorin may not be best way to fight those factors when it comes...