Transcript Testosterone: To Replace or Not to Replace?

Testosterone: To Replace or Not to
Replace?
Hanna Raber, PharmD, TTS
PGY2 Ambulatory Care Resident
Saint Joseph Health System
Mishawaka, Indiana
This speaker has no actual or potential conflicts of interest to
disclose in relation to this presentation
Objectives
• Describe basic recommendations from the
Endocrine Society for hypogonadism screening
• List two benefits and risks associated with
testosterone replacement in men with
hypogonadism
• Evaluate published medical literature regarding
testosterone replacement therapy and the
association with cardiovascular events
Do You Have Low T?
Picture from: http://www.nytimes.com/2013/11/24/business/selling-that-new-manfeeling.html
Picture from: http://www.uvcshopping.com/shops/services/low-t
Endocrine Society 2010 Guidelines
Hypogonadism:
 Results from failure of the testis to produce
physiological levels of testosterone
Screening:
 No routine screening in general population
 Diagnosis = symptoms + low testosterone levels
 Measure serum testosterone levels in the
morning
 Repeat serum testosterone measurement for
diagnosis
J Clin Endocrinol Metab. 2010; 95: 2536-59
Symptoms of Androgen Deficiency
More Specific
Less Specific
Delayed or incomplete sexual
development
Decreased energy, motivation, selfconfidence
Reduced libido and spontaneous
erections
Depressed mood
Hot flashes, sweats
Poor concentration and memory
Breast discomfort, gynecomastia
Sleep disturbances
Loss of body hair
Mild anemia
Small or shrinking testes
Reduced muscle bulk
Infertility, low sperm count
Increased body fat
Height loss, low trauma fracture, low
BMD
Diminished physical performance
J Clin Endocrinol Metab. 2010; 95: 2536-59
Pros of Testosterone Replacement
 Improves sexual function
 Increases bone mineral density
 Increases free-fat mass
 Increases strength
 Improves lipid profile
 Improves insulin resistance
 Increases time to ST depression
J Clin Endocrinol Metab. 2010; 95: 2536-59
Cons of Testosterone Replacement
 Prostate hypertrophy, prostate cancer
 Decrease in HDL
 Induction or worsening of OSA
 Increase in hemoglobin and hematocrit
 Side effects
 Cardiovascular events???
J Clin Endocrinol Metab. 2010; 95: 2536-59
FDA Alert
• Issued 3/3/2015
• “…FDA has concluded that there is a possible
increased cardiovascular risk associated with
testosterone use”
• Label changes to reflect the possible
increased risk of heart attacks and strokes
FDA drug safety communication. March 3, 2015
FDA Alert
5 Observational
Studies
2 found
cardiovascular
harm with TRT
2 found
mortality
benefit
1 inconclusive
FDA drug safety communication. March 3, 2015
2 MetaAnalyses
1 found
cardiovascular
harm with TRT
1 found no
increased risk of
cardiovascular
harm
Observational Study -Vigen et al
JAMA. 2013;310:1829-36
Observational Studies-Finkle et al
Rates of MI per 1,000 persons per year
PLoS One. 2014;9:e85805
Observational Studies (+)
• Shores Study (2012)
– Male veterans older than 40 years
– Found a decreased risk of all-cause mortality
with TRT compared to no TRT
• Muraleedharan Study (2013)
– Men with type 2 diabetes in the UK
– Increased risk of all-cause mortality in men
with no TRT compared to those on TRT
J Clin Endocrinol Metab. 2012;97:2050-8
Eur J Endocrinol. 2013;169:725-33
Conclusions
• Testosterone levels should be checked in the
morning and should be repeated to make an
accurate diagnosis of hypogonadism
• Testosterone replacement therapy is
recommended for patients with low
testosterone levels AND symptoms
• Cardiovascular events have been associated
with testosterone replacement
• Untreated hypogonadism has been associated
with increased mortality
Testosterone: To Replace or Not to
Replace?
Hanna Raber, PharmD, TTS
PGY2 Ambulatory Care Resident
Saint Joseph Health System
Mishawaka, Indiana