Testosterone Therapy in Men An update

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1 Testosterone Therapy in Men An update SANDEEP DHINDSA Associate Professor of Medicine Director, Division of Endocrinology and Metabolism, Saint Louis University, St. Louis, MO

2 Presenter Disclosure None

3 Objectives identify appropriate candidates for testosterone replacement therapy monitor testosterone replacement therapy acknowledge side-effects of testosterone therapy

4 FDA Drug Safety Communication requiring labeling change to inform of possible increased risk of heart attack and stroke with use, March 3, 2015 Testosterone is an F.D.A.-approved replacement therapy only for men with disorders of the testicles, pituitary gland or brain that cause hypogonadism Testosterone should not be used to relieve symptoms in men who have low testosterone for no reasons other than aging. Health care professionals should make patients aware of the possible increased cardiovascular risk when deciding whether to start or continue a patient on testosterone therapy.

5 Decline in Testosterone with age

6 SHBG (nmol/l) Albuminbound T 50% Free T 3% BMI (kg/m2) SHBG-bound T 47% SHBG (nmol/l) Total testosterone should be measured by liquid chromatography tandem mass spectrometry Free Testosterone should be separated by equilibrium dialysis Calculated Free Testosterone (using total testosterone, SHBG and albumin) is also reliable (normal range ng/dl) AGE (years)

7 European Male Aging Study Secondary hypogonadism is more common than primary hypogonadism at all ages. Hypogonadism was defined based on low T and not symptoms Tajar et al; J Clin Endocrinol Metab, April 2010, 95(4):

8 The Syndrome of Late-Onset Hypogonadism as defined by at least three sexual symptoms and total T of <320 ng/dl and free T of <6.3 ng/dl Wu et al; N Engl J Med 2010;363:

9 Normal range of Total and Free Testosterone concentrations Young (19-40 years) healthy non-obese men (n=456) (Framingham Study Cohort) Total Testosterone (ng/dl) Free Testosterone (ng/dl) Elderly (70-89 years) healthy men (n=394) Health in Man Study (Australia) Total Testosterone (ng/dl) Free Testosterone (ng/dl) 2.5 th percentile th percentile Mean (SD) 724 (221) 14.2 (4.5) 412 (141) 5.7 (1.5) Median Total testosterone was measured using LC-MS/MS. Free testosterone was calculated using SHBG and albumin. Bhasin et al; J Clin Endocrinol Metab, August 2011, 96(8): Yeap et al, J Clin Endocrinol Metab, November 2012, 97(11): Healthy older men were those reporting excellent or very good health and who also had no history of smoking, diabetes, CVD, cancer, depression, or dementia.

10 Probability of dying from any cause according to plasma levels of Testosterone in elderly men (3690 community-dwelling men aged 70 to 89 years) * * * Quartile Quartile Quartile 3 Quartile 4 0 Total T calculated Free T Quartiles Total T (ng/dl) Calculated Free T (ng/dl) optimal range of total T: ng/dl Yeap, J Clin Endocrinol Metab, January 2014, 99(1):E9 E18

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12 The Testosterone Trials The T trials are a coordinated set of seven double blind randomized placebo controlled trials conducted at twelve US sites. 790 men older than 65 years of age who were symptomatic and had subnormal total testosterone concentration were randomized to receive testosterone (Androgel 1%) or placebo gel for a year. To enroll, subjects had to qualify on the basis of symptoms in one of the three main trials (sexual function trial, physical function trial, or the vitality trial). Other four trials: cognitive function, anemia, bone density and cardiovascular risk factors The dose of testosterone gel was adjusted to keep the concentration within the normal range for young men (19 to 40 years of age).

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17 Effect of testosterone replacement on response to sildenafil citrate in men with erectile dysfunction and low testosterone These data do not support the routine addition of testosterone to a PDE5 inhibitor therapy to improve erectile response in men with ED and low testosterone levels. Ann Intern Med Nov 20;157(10):

18 Older Men Are as Responsive as Young Men to the Anabolic Effects of Graded Doses of Testosterone on the Skeletal Muscle Changes from baseline in FFM, fat mass, leg press strength, and skeletal muscle mass in young (black bars) and older (grey bars) men in response to graded doses of testosterone enanthate. Healthy, young (n=54) and older men (n=52) were randomized to receive a long-acting GnRH agonist plus one of five different doses of testosterone enanthate (25, 50, 125, 300, and 600 mg weekly, im) for 20 wk. J Clin Endocrinol Metab, February 2005, 90(2):

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21 The Testosterone in Older Men with Mobility Limitations (TOM) trial Minimal clinically Important Difference Changes in gait speed without a load and stair-climbing power without a load did not differ significantly between the groups. Basaria et al, NEJM, 2010

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24 Testosterone Treatment did not affect Cognitive Function in Older Men With Low Testosterone and Age-Associated Memory Impairment JAMA, 2017;317(7):

25 Testosterone vs Placebo Treatment for 12 Months and Hemoglobin Concentrations in Participants in the Anemia Trial Testosterone treatment resulted in erythrocytosis (Hg >17.5 g/dl) only in nonanemic men, in 6 (2%) of 336 participants. Four of those 6 had serum T >800 ng/dl when erythrocytosis was detected. Roy et al, JAMA Internal Med, 2017

26 Snyder et al, JAMA Intern Med., 2017

27 Treatment with 1mg anastrazole or placebo in elderly hypogonadal men for one year (JCEM 2009)

28 Treatment with 1mg anastrazole or placebo in elderly hypogonadal men for one year: effect on bone mineral density (JCEM 2009)

29 PSA and Testosterone Does Testosterone replacement increase PSA? ~30%; increases PSA to normal levels. An average increase in serum PSA levels of about 0.30 ng/ml in young hypogonadal men 0.43 ng/ml in older hypogonadal men PSA (µg/l) upper normal limit Does Testosterone increase prostate volume? ~15% untreated hypogonadal men testosterone-treated hypogonadal men PSA in untreated hypogonadal men (n=47), testosterone-treated hypogonadal men (n=78), and age-matched normal men (n=75) Behre et al. Clin Endocrinol 1994 Testosterone replacement therapy has not been shown to cause an increase in incidence of BPH or prostate cancer in underpowered trials of relatively short duration (<3 years). 0 normal men

30 Effect of Testosterone Replacement Therapy on Prostate Tissue in Men With Late-Onset Hypogonadism JAMA Randomized, double-blind, placebo-controlled trial of 44 men, aged 44 to 78 years Serum testosterone levels lower than 300 ng/dl Participants received 150 mg of testosterone or matching placebo intramuscularly every 2 weeks for 6 months

31 Saturation model The saturation model suggests that testosterone is like water for a thirsty tumor. Once thirst is quenched, additional water serves only as excess. The saturation point occurs at approximately 8 nmol/l (approximately 250 ng/dl)

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33 Adverse Effects of Testosterone Therapy in Adult Men: A Systematic Review and Meta- Analysis; Fernandez-Balsells et al, JCEM 2010 Continuous outcomes Weighted mean difference Lower boundary Prostate symptom scale PSA change (ng/ml) HDL cholesterol (mg/dl) LDL cholesterol (mg/dl) Fasting triglycerides (mg/dl) Total cholesterol (mg/dl) Fasting glucose Systolic blood pressure Diastolic blood pressure Upper boundary

34 The annual rate of major adverse cardiovascular event (MI, stroke death due to cardiovascular causes) was 1.7% in both groups (7 men out of 394 in each group), a rate which would be expected in an elderly population, 20% of whom had history of myocardial infarction or stroke prior to entering the study. During a follow-up period of one year of observation after discontinuation of treatment, 2 men in testosterone group and 9 men in placebo had a cardiovascular event. While these data are reassuring, T trials are not long enough to provide definite evidence of cardiovascular safety after testosterone therapy in elderly men. Snyder et al, NEJM 2016

35 Testosterone Treatment and Coronary Artery Plaque Volume in Older Men With Low T, JAMA. 2017;317(7):

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37 Effects of Testosterone Administration for 3 Years on Subclinical Atherosclerosis Progression in Older Men With Low or Low-Normal Testosterone Levels: A Randomized Clinical Trial; Basaria et al, JAMA men 60 years or older low or low-normal total testosterone levels ( ng/dl) OR free testosterone <50 pg/ml) 156 participants were randomized to receive 7.5 g of 1% testosterone and 152 were randomized to receive placebo gel packets daily for 3 years. The dose was adjusted to achieve testosterone levels between 500 and 900 ng/dl. Coprimary outcomes included common carotid artery intimamedia thickness and coronary artery calcium; secondary outcomes included sexual function and health related quality of life.

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39 Overview of the metaanalyses A: cardiovascular events B: stroke C: mortality Lancet Diabetes and Endocrinology, November 2016

40 Effect of appropriate testosterone replacement therapy on MI, stroke and mortality in men with low testosterone P=0.005 P=0.03 P<0.001 Mean duration of treatment:- normalized-trt 3.0±2.7 years non-normalized T 1.5±1.9 years P<0.001 untreated MI Stroke mortality normalized T non-normalized T Number of subjects: Untreated (13,378), normalized T (43,931), non-normalized T (25,701) Sharma R et al. Eur Heart J, 2015

41 [June 2014] The U.S. Food and Drug Administration (FDA) is requiring manufacturers to include a general warning in the drug labeling of all approved testosterone products about the risk of blood clots in the veins (DVT and PE). The risk of venous blood clots is already included in the labeling of testosterone products as a possible consequence of polycythemia. Because there have been postmarket reports of venous blood clots unrelated to polycythemia, FDA is requiring a change to drug labeling of all testosterone products to provide a more general warning regarding venous blood clots. Testosterone Replacement Therapy and the Incidence of DVT and Pulmonary Embolism: A Retrospective Cohort Study from VA Normal on-treatment stt Group (Gp1): Adequately treated patients: 38,362. Low on-treatment stt Group (Gp2): Inadequately treated patients: 22,191. Untreated Subjects (Gp3): subjects with low baseline stt but who did not receive any TRT during the study period: 10,854 The incidence of DVT/PE was 0.5%, 0.4%, and 0.4% in Gp1, Gp2, and Gp3, respectively.

42 FDA (March 2015): We are requiring manufacturers of approved testosterone products to conduct a well-designed clinical trial to more clearly address the question of whether an increased risk of heart attack or stroke exists among users of these products. We are encouraging these manufacturers to work together on a clinical trial, but they are allowed to work separately if they so choose. On the basis of the cardiovascular event rates reported in the largest systematic meta-analysis, any randomized controlled trial aiming to detect a true difference in cardiovascular risk between treatment groups receiving exogenous testosterone and their controls would require at least 17,664 participants in each trial group. (Onasanya et al, Lancet D&E, Nov 2016) Will one randomized controlled trial resolve this issue?

43 SUMMARY FDA recommends that only organic hypogonadism be treated. TRT should be titrated to achieve serum total testosterone concentrations of ~700 in young (<40 years) men and ~400 ng/dl in elderly (>70 years) men. TRT can cause polycythemia There is no definitive evidence that TRT increases or decreases cardiovascular events.

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