Chantix Prevents Heart Attacks
Pfizer Inc. (PFE) is considering funding a clinical trial to test whether its smoking-cessation drug Chantix can help prevent heart attacks in smokers.
Prescriptions for the three-year-old drug have slowed due to publicity surrounding potential psychiatric side effects - first-quarter sales dropped 36% to $177 million. A study that demonstrates Chantix helps prevent heart attacks could mitigate the safety issues and revive sales, though there is the risk that a negative result would further damage sales.
Pfizer has received inquiries from academic researchers about testing whether Chantix helps reduce the risk of subsequent heart attacks in smokers who have already had one, Briggs Morrison, senior vice president and head of drug development in Pfizer's primary-care unit, told Dow Jones Newswires Friday. But the New York-based company hasn't yet made a decision on whether to fund such a trial.
Some might view a cardiovascular-outcomes study for Chantix as superfluous because smoking is a well-known risk factor for heart disease. And in studies, a higher proportion of Chantix users were able to stop smoking than users of a comparator drug or placebo. Thus, it's reasonable to assume that someone who uses Chantix to stop smoking will have a reduced risk of heart disease.
However, "there are others in the academic community who've said, 'We think that's probably true but wouldn't it be important to formally demonstrate that? '" Morrison said.
Morrison said Pfizer expects to reach a decision by the end of the year on whether to fund such a study. He said the company hasn't yet determined how large, long or costly it would be. Cardiovascular-outcomes studies of other drugs typically include thousands of patients and can take several years.
Pfizer presented a study in March showing that Chantix helped more smokers with a history of heart disease to quit smoking, versus a fake drug, but the study didn't measure whether that translated into fewer heart attacks.
Last year, the U.S. Food and Drug Administration issued an alert saying it was increasingly likely there is an association between use of Chantix and serious neuro-psychiatric symptoms such as suicidal thoughts, and Pfizer updated the drug's prescribing label to advise patients to stop taking the drug if these symptoms occur. Lawsuits have been filed against the company alleging use of the drug led to suicides, attempted suicides and other injuries.
Morrison said ongoing studies of Chantix could shed more light on the " questions that have come up around neuro-psychiatric symptoms."
Pfizer shares were recently up 12 cents at $13.48.
-By Peter Loftus, Dow Jones Newswires; 215-656-8289; peter.loftus@dowjones.com
Source: cnn money
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