Results of a new study indicate there could be an increased risk of heart failure from Avodart, GlaxoSmithKline’s prostate drug.
The study, published in Thursday’s New England Journal of Medicine, was intended to show that Avodart could be used as a preventative cancer medication. However, researchers discovered an unexpected spike in the number of men who developed heart failure, which may have been caused by Avodart side effects.
Avodart (dutasteride) was approved by FDA for the treatment of urinary problems in October 2002. Avodart works by reducing the size of an enlarged prostate, by reducing the enzymes that turn testosterone into DHT (dihydrotestosterone), which is the primary cause of prostate growth. Earlier this week, GlaxoSmithKline asked FDA to approve Avodart as a prostate cancer prevention drug, citing the study’s findings.
The study included about 6,700 men at high risk for prostate cancer, but who had not tested positive for the disease. The men were given Avodart or placebos for four years and then given biopsies.
While researchers found that prostate cancer was found in only 20% of the men given Avodart, as compared with 25% of men given a placebo, they also found that nearly twice as many men (30) given Avodart developed heart failure, compare with those who developed heart failure while on the placebo (16).
GlaxoSmithKline officials say that the Avodart heart failure results were unexpected and were inconsistent with other studies. They also said that the men who developed heart failure tended to be taking other drugs. Researchers say that there has been no unusual increase in Avodart heart failure risk among men who have used the drug to alleviate urinary problems from an enlarged prostate.