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Prostate Cancer Drug Linked to Heart Failure
The GlaxoSmithKline drug Avodart reduces the risk of prostate cancer, but it also might increase the chances of heart failure, according to the New England Journal of Medicine.
The findings could hurt a request filed Monday by GSK with the U.S. Food and Drug Administration to have Avodart approved as a cancer preventative, reports the Triangle Business Journal.
GlaxoSmithKline already sells Avodart as a treatment for enlarged prostate. No links to heart failure have surfaced in that indication for Avodart.
The New England Journal of Medicine study found that a daily, 0.5 mg dose of dutasteride, the active ingredient in Avodart, reduced the risk of prostate cancer by 22 percent in 6,729 men between the ages of 50 and 75.
A biopsy or prostate surgery found cancer in 659 of the 3,305 men that took dutasteride compared with 858 of the 3,424 who took a placebo.
The study also found a higher rate of cardiac failure in men taking dutasteride—0.7 percent versus 0.4 percent for those taking the placebo.
A statement issued by GlaxoSmithKline touted the positive results of dutasteride reducing the risk of prostate cancer but did not address the heart-failure issue.
Spokeswoman Sarah Alspach told the Associated Press that the heart-failure rate published in the New England Journal of Medicine report “is unexpected and inconsistent” with previous testing of the drug.
Jeff Drew writes for the Triangle Business Journal
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