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Biotech Week
February 18, 2004
SECTION: EXPANDED REPORTING; Pg. 59
LENGTH: 898 words
HEADLINE: BETH ISRAEL DEACONESS: "No compelling evidence"of prostate
cancer,
heart disease risk found in study
BODY:
A retrospective analysis by researchers at Beth Israel Deaconess
Medical
Center found no causal relationship between testosterone replacement
and
prostate cancer or heart disease risk.
The comprehensive review of 72 studies, addresses the current
controversy
about testosterone replacement therapy and its potential health risks
to men.
"We reviewed decades of research and found no compelling evidence
that
testosterone replacement therapy increases the incidence of prostate
cancer or
cardiovascular disease," said Abraham Morgentaler, MD, a urologist at
BIDMC and
associate clinical professor at Harvard Medical School. "Although it
would be
helpful to have data from long-term, large-scale studies, it must also
be
recognized that there already exists a substantial body of research on
the
effects of testosterone in men."
The study was published in the New England Journal of Medicine.
Low levels of testosterone affect an estimated 2-4 million men in
the United
States, a condition termed hypogonadism, and the prevalence of this
condition
increases with age. The symptoms include diminished libido and sense of
vitality, erectile dysfunction, reduced muscle mass and bone density,
depression, and anemia.
The causes of hypogonadism may be classified as primary, meaning
inadequate
function of the testes; secondary, inadequate pituitary stimulation of
the
testes; or a combination of primary and secondary causes, which is
common in
older men. Testosterone supplementation, in the form of injections,
patches,
gels and a buccal tablet, is designed to elevate a hypogonadal man's
testosterone levels into the normal physiologic range and alleviate
symptoms.
"Testosterone is only for men who have symptoms of low testosterone
combined
with a confirmatory blood test. Testosterone therapy can be beneficial
and safe
for these men as long as they are appropriately monitored by their
physician,"
said Morgentaler.
It has been known since the 1940's that severe reductions of
testosterone can
cause shrinkage of metastatic prostate cancer, and therefore there has
been a
concern that raising testosterone levels might cause growth of any
hidden
prostate cancers. However, the study by Ernani L. Rhoden, MD, and
Morgentaler
found no connection between higher testosterone levels and prostate
cancer, nor
did they find evidence that testosterone treatment causes prostate
cancer.
In fact, they note that prostate cancer becomes more prevalent
exactly at the
time of a man's life when testosterone levels decline. To date,
prospective
studies have demonstrated no difference in prostate cancer incidence
among
hypogonadal men using testosterone therapy compared to men in the
general
population.
Regarding benign prostatic hyperplasia (BPH), multiple studies have
failed to
demonstrate consistent exacerbation of voiding symptoms during
testosterone
supplementation. "The impact of testosterone therapy on benign prostate
growth
appears to be mild," said Rhoden, "and rarely of clinical significance.
However,
testosterone therapy should be used cautiously in men with severe
urinary
symptoms."
Monitoring the prostate during testosterone therapy is mandatory,
given the
theoretical concern that testosterone treatment may stimulate the
growth of an
occult cancer. Before and during treatment men should undergo regular
evaluation, with a digital examination of the prostate, and a blood
test called
prostate-specific antigen (PSA). Patients with an abnormal prostate
exam or an
elevated PSA should undergo a prostate biopsy before initiating
testosterone
replacement to exclude the possibility that cancer is present. To
monitor BPH,
they recommend determining a base-line voiding history at the start of
treatment
and assessing urinary symptoms at follow-up.
The belief that testosterone may be a risk factor in cardiovascular
disease
is based on the observation that more men than women have
cardiovascular events
and men have higher testosterone levels than women. However, Rhoden and
Morgentaler write that few, if any, data support a causal relation
between
higher testosterone levels and heart disease.
Indeed, several studies suggest that higher testosterone levels may
actually
have a favorable effect on atherosclerosis and heart disease. Studies
of
testosterone replacement therapy have not demonstrated an increased
incidence of
cardiovascular disease, myocardial infarction, stroke, or angina,
according to
the retrospective analysis.
Rhoden and Morgentaler describe other potential risks or side
effects from
testosterone replacement therapy as infrequent (acne or oily skin,
sleep apnea);
rarely of clinical significance (fluid retention); or reversible with
cessation
of treatment (gynecomastia, testicular atrophy or infertility).
Testosterone
treatment should be used cautiously or not at all in men with advanced
liver
disease. Skin reactions are commonly encountered in men being treated
with the
patch with a low incidence observed with testosterone gel (Rhoden EL,
Morgentaler A. Risks of testosterone-replacement therapy and
recommendations for
monitoring. N Engl J Med, 2004;350(5):482-92).
This article was prepared by Biotech Week editors from staff and
other
February 18, 2004
SECTION: EXPANDED REPORTING; Pg. 59
LENGTH: 898 words
HEADLINE: BETH ISRAEL DEACONESS: "No compelling evidence"of prostate
cancer,
heart disease risk found in study
BODY:
A retrospective analysis by researchers at Beth Israel Deaconess
Medical
Center found no causal relationship between testosterone replacement
and
prostate cancer or heart disease risk.
The comprehensive review of 72 studies, addresses the current
controversy
about testosterone replacement therapy and its potential health risks
to men.
"We reviewed decades of research and found no compelling evidence
that
testosterone replacement therapy increases the incidence of prostate
cancer or
cardiovascular disease," said Abraham Morgentaler, MD, a urologist at
BIDMC and
associate clinical professor at Harvard Medical School. "Although it
would be
helpful to have data from long-term, large-scale studies, it must also
be
recognized that there already exists a substantial body of research on
the
effects of testosterone in men."
The study was published in the New England Journal of Medicine.
Low levels of testosterone affect an estimated 2-4 million men in
the United
States, a condition termed hypogonadism, and the prevalence of this
condition
increases with age. The symptoms include diminished libido and sense of
vitality, erectile dysfunction, reduced muscle mass and bone density,
depression, and anemia.
The causes of hypogonadism may be classified as primary, meaning
inadequate
function of the testes; secondary, inadequate pituitary stimulation of
the
testes; or a combination of primary and secondary causes, which is
common in
older men. Testosterone supplementation, in the form of injections,
patches,
gels and a buccal tablet, is designed to elevate a hypogonadal man's
testosterone levels into the normal physiologic range and alleviate
symptoms.
"Testosterone is only for men who have symptoms of low testosterone
combined
with a confirmatory blood test. Testosterone therapy can be beneficial
and safe
for these men as long as they are appropriately monitored by their
physician,"
said Morgentaler.
It has been known since the 1940's that severe reductions of
testosterone can
cause shrinkage of metastatic prostate cancer, and therefore there has
been a
concern that raising testosterone levels might cause growth of any
hidden
prostate cancers. However, the study by Ernani L. Rhoden, MD, and
Morgentaler
found no connection between higher testosterone levels and prostate
cancer, nor
did they find evidence that testosterone treatment causes prostate
cancer.
In fact, they note that prostate cancer becomes more prevalent
exactly at the
time of a man's life when testosterone levels decline. To date,
prospective
studies have demonstrated no difference in prostate cancer incidence
among
hypogonadal men using testosterone therapy compared to men in the
general
population.
Regarding benign prostatic hyperplasia (BPH), multiple studies have
failed to
demonstrate consistent exacerbation of voiding symptoms during
testosterone
supplementation. "The impact of testosterone therapy on benign prostate
growth
appears to be mild," said Rhoden, "and rarely of clinical significance.
However,
testosterone therapy should be used cautiously in men with severe
urinary
symptoms."
Monitoring the prostate during testosterone therapy is mandatory,
given the
theoretical concern that testosterone treatment may stimulate the
growth of an
occult cancer. Before and during treatment men should undergo regular
evaluation, with a digital examination of the prostate, and a blood
test called
prostate-specific antigen (PSA). Patients with an abnormal prostate
exam or an
elevated PSA should undergo a prostate biopsy before initiating
testosterone
replacement to exclude the possibility that cancer is present. To
monitor BPH,
they recommend determining a base-line voiding history at the start of
treatment
and assessing urinary symptoms at follow-up.
The belief that testosterone may be a risk factor in cardiovascular
disease
is based on the observation that more men than women have
cardiovascular events
and men have higher testosterone levels than women. However, Rhoden and
Morgentaler write that few, if any, data support a causal relation
between
higher testosterone levels and heart disease.
Indeed, several studies suggest that higher testosterone levels may
actually
have a favorable effect on atherosclerosis and heart disease. Studies
of
testosterone replacement therapy have not demonstrated an increased
incidence of
cardiovascular disease, myocardial infarction, stroke, or angina,
according to
the retrospective analysis.
Rhoden and Morgentaler describe other potential risks or side
effects from
testosterone replacement therapy as infrequent (acne or oily skin,
sleep apnea);
rarely of clinical significance (fluid retention); or reversible with
cessation
of treatment (gynecomastia, testicular atrophy or infertility).
Testosterone
treatment should be used cautiously or not at all in men with advanced
liver
disease. Skin reactions are commonly encountered in men being treated
with the
patch with a low incidence observed with testosterone gel (Rhoden EL,
Morgentaler A. Risks of testosterone-replacement therapy and
recommendations for
monitoring. N Engl J Med, 2004;350(5):482-92).
This article was prepared by Biotech Week editors from staff and
other
