Testosterone Therapy Increases Cardiovascular Risk
in Older Men
Results of large study urges both cautious
testosterone prescribing and additional investigation –
Nov. 6, 2013 - Among a group of older men who
underwent coronary angiography and had a low serum testosterone level,
the use of testosterone therapy was associated with increased risk of
death, heart attack, or ischemic stroke, according to a study in the
November 6 issue of JAMA.
An estimated 2.9 percent of U.S. men over 40 years
old are prescribed testosterone therapy, yet there have been limited
randomized trial data examining the long term benefits and risks.
“Rates of testosterone therapy prescription have
increased markedly in the United States over the past decade. Annual
prescriptions for testosterone increased by more than 5-fold from 2000
to 2011, reaching 5.3 million prescriptions and a market of $1.6 billion
in 2011, according to background information in the article.
“Professional society guidelines recommend
testosterone therapy for patients with symptomatic testosterone
deficiency. In addition to improving sexual function and bone mineral
density and increasing free-fat mass and strength, treatment with
testosterone has been shown to improve lipid profiles and insulin
resistance and increase the time to ST depression [a finding on an
electrocardiogram suggesting benefit] during stress testing.”
However, a recent randomized clinical trial of
testosterone therapy in men with a high prevalence of cardiovascular
diseases was stopped prematurely due to adverse cardiovascular events
raising concerns about testosterone therapy safety.
Rebecca Vigen, M.D., M.S.C.S., of the University of
Texas at Southwestern Medical Center, Dallas and colleagues evaluated
the association between the use of testosterone therapy and all-cause
mortality, myocardial infarction (MI; heart attack), and stroke among
male veterans and whether this association was modified by underlying
coronary artery disease (CAD).
The study included 8,709 men with low testosterone
levels (<300 ng/dL) who underwent coronary angiography in the Veterans
Affairs (VA) system between 2005 and 2011. There was a high level of
co-existing illnesses among this group, including prior history of heart
attack, diabetes, or CAD. Of the 8,709 patients, 1,223 (14.0 percent)
initiated testosterone therapy after a median (midpoint) of 531 days
The average follow-up was approximately 2 years,
3.5 months. The primary measured outcome for the study was a composite
of all-cause mortality, heart attack, and ischemic stroke.
The researchers found that the proportion of
patients experiencing events 3 years after coronary angiography was 19.9
percent in the no testosterone therapy group (average age, 64 years) and
25.7 percent in the testosterone therapy group (average age, 61 years),
for an absolute risk difference of 5.8 percent.
Even accounting for other factors that could
explain the differences, use of testosterone therapy was associated with
adverse outcomes and was consistent among patients with and without CAD.
The increased risk of adverse outcomes associated
with testosterone therapy use was not related to differences in risk
factor control or rates of secondary prevention medication use because
patients in both groups had similar blood pressure, low-density
lipoprotein levels, and use of secondary prevention medications.
“Additional information from the ongoing T Trial -
a randomized trial of 800 men aged 65 and older with diminished walking
ability, interest in sex, energy, memory or iron levels in blood who
will receive testosterone gel or placebo for one year - may provide
important guidance to older men who meet current recommendations for
testosterone therapy. Until then prescribers and patients should be
wary." – Dr. Anne R. Cappola, Perelman School of Medicine at the
University of Pennsylvania, Associate Editor for JAMA
“These findings raise concerns about the potential
safety of testosterone therapy,” the authors write. “Future studies
including randomized controlled trials are needed to properly
characterize the potential risks of testosterone therapy in men with
Editorial: Testosterone Therapy and Risk of
Cardiovascular Disease in Men
“Perhaps the most important question is the
generalizability of the results of this study to the broader population
of men taking testosterone: men of this age group who are taking
testosterone for ‘low T syndrome’ or for antiaging purposes and younger
men taking it for physical enhancement,” writes Anne R. Cappola, M.D.,
Sc.M., of the Perelman School of Medicine at the University of
Pennsylvania, Philadelphia, in an accompanying editorial.
“Are the benefits—real or perceived—for these
groups of men worth any increase in risk? These populations represent a
sizable group of testosterone users, and there is only anecdotal
evidence that testosterone is safe for these men.”
“In light of the high volume of prescriptions and
aggressive marketing by testosterone manufacturers, prescribers and
patients should be wary. There is mounting evidence of a signal of
cardiovascular risk, to which the study by Vigen et al contributes. This
signal warrants both cautious testosterone prescribing and additional
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