Cholesterol drug Vytorin may actually work, new data shows
FILE - This 2004 file photo provided by Schering-Plough Corp. shows the cholesterol-lowering drug Vytorin. (AP Photo/Schering-Plough Corp., File)
Dismissed by some cardiologists as an expensive placebo several years ago, the cholesterol-lowering pill Vytorin may be poised for a comeback.
Researchers at the American Heart Association meeting on Monday in Chicago presented data from an randomized, double-blind study of 18,144 high-risk patients that found that patients taking Vytorin -- a combination of the cholesterol-lowering statin Zocor plus Zetia, a non-statin -- experienced fewer heart attacks, strokes and repeat hospitalizations than those taking just statins.
The results, which have not yet been peer-reviewed, could dramatically alter the landscape for the multi-billion-dollar cholesterol drug industry. The American Heart Association and the American College of Cardiologists currently only recommend statins.
Statins, which lower the amount of LDL or bad cholesterol in the blood, are considered a kind of miracle drug in modern medicine. Among the most widely prescribed in the world, they are often able to lower a person's cholesterol to very low levels with few noticeable side effects. But they don't work for everyone and some can't tolerate a full dose -- they can cause muscle pain, digestive issues and liver damage -- and until now there haven't been any good alternatives.
Statins work by reducing the cholesterol made in the liver while Zetia or ezetimibe work by blocking absorption of the cholesterol.
The difference between the statin and combination therapy was modest, but significant. The study, which was funded by Merck and conducted at multiple centers around the world, followed patients for an average of six years after a hospitalization and found a 6.4 percent reduction in relative risk of a repeat incident between taking just statins and taking both drugs and that the side effects reported were lower than those for statins.
Vytorin has been among the most controversial drugs in the cardiovascular world. After the drug's developers -- Merck and Schering-Plough -- were accused of suppressing negative data in 2007-2008, prescriptions fell and the companies' stock prices plunged. Merck, which admitted no wrongdoing, paid $688 million to settle lawsuits from shareholders regarding the controversy.
Some researchers who were not involved in the study said back then that they wondered whether Vytorin and Zetia lowered cholesterol but did not reduce heart attacks or strokes. The results released Monday appeared to indicate that bringing a patient's cholesterol lower does appear to reduce heart incidents.
Merck says it plans to submit the data to the Food and Drug Administration in mid-2015 to get approval to market the drug for reducing major cardiovascular events.
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