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nation, include rectal prostate examination and blood
samples for measurement of testosterone, PSA, hemato-
crit and hemoglobin levels
39
(
B
).
Recommendation
Consultations should be held every three or six months
after starting treatment, and then annually to evaluate if
the symptoms have responded to treatment or if the pa-
tient had any adverse effects.
W
hat
level
should
the
testosterone
dose
be
kept
at
for
patients
undergoing
ART?
The current data is insufficient to determine the opti-
mum level of testosterone for efficacy and safety. Curren-
tly, average-to-low levels for healthy young adults appear
to be appropriate as therapeutic target.
Supraphysiological levels should be avoided. Phar-
macogenetics linked to AR (Androgen Receptor) may
be a future option to individualize the optimal level of
testosterone
40
(
B
).
Monitor testosterone levels 3 and 6 months after star-
ting ART. For patients that receive intramuscular replace-
ment, the levels of testosterone should be interpreted in
midway between one injection and another
38
(
B
).
Recommendation
Currently, average or low levels for healthy young adults
appear to be appropriate as a therapeutic target.
W
hat
level
should
hematocrit
be
kept
at
for
patients
undergoing
ART?
In patients underg oing ART, hematocrit should be mea-
sured 3, 6 and 12 months after the start of treatment, and
then yearly. An increase in hematocrit over 50% was the
most common adverse effect found in ART according to
a major review of evidence. This review showed that the-
re was a significantly higher number of participants with
hematocrit above 50% in the group undergoing testoste-
rone replacement than the placebo group
37
(
A
). The criti-
cal threshold for hematocrit is not yet clear. Dose adjust-
ments may be required to keep hematocrit below 52% to
55%
39
(
B
). According to another recommendation, if the
hematocrit is above 54% ART should be discontinued un-
til the hematocrit returns to safe levels
38
(
B
).
Recommendation
Maintain the level of hematocrit at up to 54%.
W
hat
about
liver
funcion
tests
?
The use of oral testosterone preparations could lead to he-
patotoxic effects. testosterone undecanoate is an oral pre-
paration that seems to have no significant hepatotoxicity.
A study with good evidence conducted with 237 men
aged between 60 and 80 for 6 months showed no chan-
ges in liver function with ART using oral testosterone un-
decanoate. The study suggests that long term research is
needed to establish safety
41
(
A
).
Intramuscular injections and transdermal prepa-
rations do not appear to be associated with liver dys-
function.
Therefore, the measurement of liver function is requi-
red only in patients with orally administered ART
42
(
D
).
Only 17a-alkylated oral preparations such as fluoxy-
mesterone and methyltestosterone display hepatotoxicity.
Recommendation
Liver function monitoring is not recommended in pa-
tients on ART with any pharmaceutical form other than
17a-alkylated oral preparations.
I
s
it
important
to monitor
bone mass
?
A systematic review of randomized clinical trials lasting
6 months to 3 years that evaluated the effects of ART on
bone mineral density remained inconsistent and inaccu-
rate, though bone mineral density appears to increase
with ART
43-45
(
A
).
It is recommended to assess bone mass of the lum-
bar spine and femur neck after one to two years of ART in
hypogonadic men with osteopenia or osteoporosis
38
(
B
).
Recommendation
It is recommended to assess bone mass of the lumbar spi-
ne and femur neck after one to two years of ART in hypo-
gonadic men with osteopenia or osteoporosis.
H
ow
should
prostate
cancer
be
monitored
?
After starting ART, patients should be monitored for pros-
tate disease, with rectal examination and PSA measure-
ments 3, 6 and 12 months after treatment, and then an-
nually, if there are no abnormalities.
The patient should undergo prostatic investigation if:
1.
PSA is higher than 4 ng/mL or 3 ng/mL in men with
a high risk of prostate cancer;
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