Study adds weight to case against cholesterol drug Zetia

 
Bad news continues to buffet the once-blockbuster cholesterol drug ezetimibe, which is sold under the brand name Zetia. Backing up research released last year, a new study has found that ezetimibe does not reduce fatty build-ups in the arteries, despite lowering levels of "bad" (LDL) cholesterol in the blood. On the other hand, one of the oldest treatments for high cholesterol—the B vitamin niacin—seems to help on both counts, say the researchers.

The study included 363 people with heart disease, or a high risk of the disease, who had been taking drugs called statins for several years to lower their cholesterol. Statins are the usual go-to drug when changes in diet and exercise don't reduce a person's cholesterol enough. But sometimes even statins fall short and people need additional treatment. Ezetimibe was approved by the FDA as a supplemental treatment, and for occasional use on its own, in 2002. Besides Zetia, you can also get a pill called Vytorin that combines ezetimibe with a statin (the earlier research looked at this combined form).

In the new study, half the people took ezetimibe and half took an extended-release version of niacin, in addition to their statin. All had regular ultrasound scans to check the narrowness of the arteries in their necks. The level of build-up in these blood vessels can help predict a person's risk of having a heart attack or stroke.

When the researchers saw that people taking niacin had notable improvement in their arteries while those taking ezetimibe did not, they decided to stop the study early. This meant that only 208 patients completed the full 14 weeks of the study. Pulling the plug early has turned out to be a somewhat controversial move, as it has meant there's less data to backup the potential benefits of taking niacin along with a statin. However, the researchers felt it was warranted since the difference between the two treatment groups was so pronounced.

The study also found that people taking ezetimibe were slightly more likely to have died, had a heart attack, or had other serious heart or circulation problems during the study. However, the number of participants with these problems was too small to draw firm conclusions.

What you need to know. These findings are another major blow to ezetimibe. They come on the heels of reports that the drug may raise the risk of cancer and a decision by its manufacturers to pay out $41.5 million to settle claims that the drug's benefits were misrepresented.

Consumer Reports has recommended that doctors not prescribe Zetia or Vytorin to new patients, and that they re-evaluate patients already taking the drugs, to make sure the potential benefits outweigh the potential risks. So what should you do if you're a patient who falls into this latter category? It's important that you don't suddenly stop taking any medication you've been prescribed. But if you have concerns, make an appointment to discuss these with your doctor.

—Sophie Ramsey, patient editor, BMJ Group

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