THE TESTOSTERONE TRIALS
The first trials tracked 790 men age
65 and older with low levels of testosterone
and symptoms attributable to
low-T, including sexual problems, fatigue,
muscle weakness, or impaired
memory and thinking.
Initial trial findings, published last
year in the Journal of the American
Medical Association, reveal a mixed
bag of benefits and
risks. For anemic
men, 54 percent with
unexplained anemia
and 52 percent with
anemia from known
causes showed a
significant increase in
red blood cells, compared
with 15 percent
and 12 percent, respectively,
of those in
the placebo group.
One study found
that a quarter of
new users received
prescriptions
without their
hormone levels
even being tested.
Likewise, in a measure of the amount
of mineral in bone and estimated
bone strength, after one year of treatment,
older men with low T showed
a significant increase in volumetric
bone mineral density (vBMD) and
estimated bone strength compared
to men in the control group. These
increases were higher in the spine
than in the hip.
AREAS OF CONCERN
Less encouraging were the cardiovascular
and cognitive trials. The former
found a buildup of arterial plaque, a
risk factor for cardiovascular disease,
among the testosterone-treated
group. Though researchers conclude
that a larger and longer trial is
needed to determine its full significance,
this was enough to prompt
the FDA to issue an advisory of the
increased risk for heart attack and
stroke. TRT package labels currently
carry an FDA-mandated warning of
potential heart risks.
The cognition trials
focused on older
men with age-associated
memory impairment
(AAMI).
As opposed to
dementia, AAMI
is a milder type of
cognitive decline.
The results showed
no improvement in
cognitive ability.
A MORE BALANCED APPROACH
The conclusion published on the NIH
website calls for further trials and
urges a more measured prescriptive
approach to balance the benefits
and risks of TRT. Evan Hadley,
M.D., director of NIA’s Division of
Geriatrics and Clinical Gerontology,
highlights the need for decisions
about testosterone treatment “to be
individualized, taking into account
each patient’s balance of risks for the
various conditions that testosterone
treatment could affect.”
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