Adverse cardio effects derail testosterone gel study

A five-year-old study designed to determine if a testosterone gel could bolster the strength of frail men over the age of 65 had to be suspended at the end of last year after researchers discovered a raft of serious cardiovascular problems among the subjects taking the hormone therapy. The New England Journal of Medicine revealed the side effects just last week.

Researchers said that the 209 men recruited for the study did demonstrate significant improvements in muscle strength and mobility after being treated with testosterone, which has been provided to a growing number of older men interested in counteracting the effects of aging. But 10 of the men treated with testosterone experienced cardiovascular issues--with one of them dying of a heart attack--compared to only one similar case in the control group.

"There was a great deal of consternation and deliberation," Boston University Professor Shalender Bhasin told the New York Times. "The lesson to be learned here is that physicians and patients, especially older men who are considering testosterone therapy, should weigh these findings of adverse events in their decision making."

Researchers planning a much larger testosterone study quickly adjusted their protocols and laid plans for additional safety monitoring during the trial. Testosterone therapies have been a hot commodity among developers. Just last March Eli Lilly paid $50 million upfront to license an underarm testosterone therapy being developed by Australia's Acrux. 

- here's the story from the New York Times

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