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Researchers found that for older men, hormone replacement therapy
with testosterone gel might improve bone health and help avoid
anemia, but it wouldn't help with thinking skills. Two studies
looking at testosterone use and heart health produced mixed results.
The new studies substantially improve the information available on
testosterone treatment, said Susan Ellenberg, who co-authored four
of the new studies.
"There are definitely benefits and potential risks," said Ellenberg,
a professor of biostatistics in the Perelman School of Medicine at
the University of Pennsylvania in Philadelphia. "It’s not an
overwhelming conclusion that every man over 65 should be on this or
stay away from it."
Testosterone levels tend to decline as men age. Doctors sometimes
prescribe testosterone gel - known as androgen replacement therapy.
Four of the new studies are the last in a group of seven known as
the Testosterone Trials, which evaluated the use of androgen
replacement therapy in men over 65 with low testosterone unrelated
to any health condition.
The three earlier Testosterone Trials, published last year in the
New England Journal of Medicine, found that testosterone therapy
improved sexual function but produced mixed results for physical
function and vitality. (See Reuters Health story of Feb 17, 2016
here: http://reut.rs/2m5wYCP.)
In one of the new studies published today in JAMA, researchers
compared cognitive function over 12 months in 247 men using
testosterone gel and 246 men using a placebo. All the men had memory
problems to start with, and there was no difference in cognitive
functions at the end of the study.
Two new studies in JAMA Internal Medicine did find benefits of
testosterone gel over placebo. Men with anemia - the result of too
few healthy red blood cells - had their conditions improve with
testosterone gel. Additionally, men using testosterone gel had
increases in bone density and strength, but more studies are needed
to determine if those men are also less likely to have bone
fractures.
The last of the new Testosterone Trials evaluated heart health in
138 older men with low testosterone and evidence of hypogonadism,
which occurs when the testes don't produce enough of the hormone.
Seventy-three participants used testosterone gel and 65 used a
placebo.
At the end of that study, compared to men using the placebo, men
using testosterone gel had a greater increase in coronary artery
plaque, which is tied to poor heart health.
"If you’re looking for benefits, you’d like to see it in the other
direction," Ellenberg told Reuters Health.
Clouding the picture on heart health and androgen replacement
therapy is a fifth study from Kaiser Permanente in JAMA Internal
Medicine that linked testosterone gel to fewer cardiovascular events
like strokes and heart attacks.
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The researchers compared data from 8,808 men age 40 and older who
received androgen replacement therapy for low testosterone and
35,527 men who never received the treatment.
The rate of cardiovascular events like heart attacks and strokes
among men who received testosterone was about 17 per 1,000 people
per year, compared to about 24 events per 1,000 per year among men
who didn't get the treatment.
T. Craig Cheetham, who led the new study, said previous studies
suggested an increased risk of heart problems tied to testosterone
use.
"We were a little surprised to find lower rates," said Cheetham, of
the Kaiser Permanente Southern California Department of Research and
Evaluation in Pasadena.
The new study can't prove testosterone treatment reduced the risk of
cardiovascular problems, he told Reuters Health.
"The results suggest we didn’t find in our population that there was
an increased risk," he said. "I think that’s as far as I would go."
In March 2015, the U.S. Food and Drug Administration (FDA)
emphasized testosterone treatments are "approved only for men who
have low testosterone levels caused by certain medical conditions."
The FDA also said there is a possible increased risk of heart
attacks and strokes with testosterone treatments. The agency is
requiring manufacturers to conduct "a well-designed clinical trial
to more clearly address the question of whether an increased risk of
heart attack or stroke exists among users of these products."
(http://bit.ly/2mjvSiu)
SOURCE: http://bit.ly/2lJzJc6, http://bit.ly/2lJimbm and http://bit.ly/2lJuDNd
JAMA, online February 21, 2017; and http://bit.ly/2lJDH4N, http://bit.ly/2lJzP3s
and http://bit.ly/2lJpjJs JAMA Internal Medicine, online February
21, 2017.
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