Testosterone Treatment in Older Men

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1 Testosterone Treatment in Older Men J. Bruce Redmon, M.D. Professor Division of Endocrinology Departments of Medicine and Urologic Surgery Disclosure Information I have no financial relationships to disclose. I will not discuss off label use and/or investigational use in my presentation. Outline Trends in testosterone prescribing. How do we diagnose testosterone deficiency? What are expected benefits of treatment? What are options for treatment? Are there risks of treatment? 1

2 Testosterone Prescriptions in the US

3 What is a Normal Testosterone Level? Testosterone Physiology SHBG - aging, hyperthyroidism, hepatitis, estrogens, anticonvulsants - obesity, hypothyroidism nephrotic syndrome, androgens GnRH H P LH -- Free T SHBG-T T T Alb-T Total Testosterone What is Normal Testosterone Framingham Heart Study Young healthy men Mean/Median 700 ng/dl (FT 14 ng/dl) 2.5 th 350 (FT 7) 1 st 280 (FT 5-6) Univ Washington very healthy older men Mean 420 ng/dl; 20% < 300 EMAS Late onset hypogonadism 3 sexual symptoms-libido, AM erections, ED T < 320 ng/dl and FT < 6.4 ng/dl 3

4 Measuring Testosterone Morning blood sample total testosterone Repeat abnormal result Assess free testosterone in selected patients Obese Equivocal, borderline, low normal total levels Assessing free T levels Unreliable assays Gold standard equilibrium dialysis expensive, time consuming Estimate free T using total T and SHBG (on-line calculator) 24 hr Testosterone Profile in a Healthy Young Man Spratt, AJP, Hypogonadism Signs and Symptoms 4

5 Hypogonadism Signs and Symptoms Decreased libido Decreased frequency of erections and sexual events Female body habitus Decrease/absence of androgen dependent hair Decreased bone density Smaller testes Increased breast tissue ADAM Does Treatment Make A Difference? 5

6 Testosterone Rx in Aging Males Small increase in muscle mass, decrease in fat mass (2-3 kg); inconsistent effects on muscle strength and minimal effects on functional status. Some increase in bone density (if lower testosterone at baseline or higher testosterone dose). No clear benefit in erectile function, mood, cognitive function. NEJM 9/12/13 T Levels and Effects Baseline T ng/dl Incr body fat < 350 Decr lean mass < 200 Decr leg strength < 45 (female levels) Decr sexual desire < 200 Decr erectile function < 200 6

7 Testosterone Therapy Weight Loss and Testosterone Levels Corona, Eur J Endocrin, 2013 Testosterone Therapy Alkylated testosterone (methyltestosterone) Short half-life, liver toxicity Intramuscular T esters T enanthate, T cypionate, T undecanoate Transdermal patch Transdermal gel Buccal preparation Subcutaneous testosterone pellets Nasal testosterone 7

8 Are there risks of treatment? Testosterone Rx in Aging Males Adverse Effects Fernandez-Balsells, studies, 4 > 1 yr duration (458 men) T Rx associated with Increased risk of erythrocytosis (RR 3.15, ) Decrease (trivial) in HDL cholesterol No increased risk of composite prostate outcomes, cardiovascular events or mortality 8

9 FDA January, 2014 Drug safety communication FDA investigating risk of stroke, MI and death in men taking testosterone. No conclusion at this time that there is increased risk. June, 2014 General warning Risk of venous thromboembolic disease. Where to Go From Here? 2002 NIH asked IOM to review and make recommendations regarding future directions for clinical trials of T therapy in older men. IOM recommendations: Establish the nature of benefits in populations of aging men most likely to see benefit. Initial short term efficacy trials in older men ( 65) with clinically low T levels and at least one symptom that may be related to T deficiency. Establish clear benefit before assessing long term risk. Guidelines AACE 2002 Total T in am; repeat to confirm. SHBG or FT if borderline, equivocal. Aging symptoms, T < 200 ng/dl may be potential candidates; alternative mean-2.5 SD (~ 320 ng/dl). Endocrine Society 2010 Consistent signs/sx and unequivocally low T. Measure total T in am. Confirm Total T (LL of lab ref range, ng/dl). Free T (LL of lab ref range, 5 9 ng/dl) Aging No panel consensus - < vs < 200 ng/dl ISA/ISSAM/EAU/EAA/ASA 2009 Symptoms and signs Total T measured 7 11 AM > 350 ng/dl does not require replacement < 230 ng/dl usually benefits from T treatment ng/dl repeat T and SHBG; FT < 6.5 ng/dl supporting evidence for T treatment. EMAS 3 sexual symptoms Total T < 320 ng/dl FT < 6.4 ng/dl 9

10 Summary New modalities of T therapy, marketing and the aging US population have increased awareness of testosterone levels in men. Many purported symptoms of low T are not well supported by data. Optimal criteria for diagnosing clinically important testosterone deficiency and possible adverse effects of long-term therapy are unknown. Goals should be to identify the (rare) man with unequivocal hypogonadism, reassure men with adequate testosterone status and discuss management options with men with equivocal testosterone status. 10

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