Testosterone; What s all the hype? KRISTEN WYRICK, LTCOL,USAFR, MC USUHS, FAMILY MEDICINE JOINT BASE LANGLEY-EUSTIS

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1 Testosterone; What s all the hype? KRISTEN WYRICK, LTCOL,USAFR, MC USUHS, FAMILY MEDICINE JOINT BASE LANGLEY-EUSTIS

2 The faces of Low Testosterone

3 What your patients are seeing

4

5 Pharmacy Industry Testosterone sales in $300 million to $2.3 billion Estimated to hit $5 billion by 2018 Advertising budget $100 million annually Direct to consumer advertising Research that is pharma funded shows significantly lower risk from testosterone than those studies which are independently funded Some leading speakers/authors on this topic have relationships with makers of testosterone products or with the legal community

6 The Legal side

7

8 Preview Late onset Androgen Deficiency Clinical Practice Guideline Testosterone therapy Cardiovascular controversy Prostate Cancer Review recommendations Questions

9 Low T Syndrome Syndrome associated w/ serum testosterone <317ng/dL Normal decline in free testosterone w/ age- 1.3% a year age Approx 40% of men in their 60 s have testosterone levels in this range Studies show that 5% of all men years have symptomatic androgen deficiency Studies have not shown any significant patient oriented outcomes in treating the general population Side Note- If an obese male loses 17 lbs -testosterone will go up by 15% (no drugs)

10 Signs and Symptoms Low muscle mass Low energy Decreased libido Erectile Dysfunction Metabolic syndrome Gynecomastia Loss of Body Hair Dysthymia Poor concentration Sleep disturbances Anemia Increased BMI Diminished work performance Low bone mineral density

11 Endocrine Society CPG 2010 Reasonable to screen men with classic signs and symptoms of androgen deficiency Measure morning total Testosterone level with reliable assay If low, then confirm by repeating measurement with free and total Do not screen general population Evaluate and monitor patients on treatment at 3 mos and annually Goal for treatment is to restore their testosterone to mid-normal range ng/dl

12 Who Not to Treat Prostate Cancer/ Breast Cancer PSA > 3ng/ml Undiagnosed prostate nodule/ induration or symptomatic BPH HCT >50% Untreated obstructive sleep apnea Uncontrolled severe heart failure

13 Testosterone Therapy Recommended regimens for initiating therapy 100mg weekly or 200mg bi-weekly t. cypionate IM $30.00/mo 1-2 4mg patches applied to skin nightly $400.00/mo 5-10g of t. gel applied daily $500.00/mo 30mg of bioadhesive, buccal t. tablet q12h $400.00/mo ***Adjust dose and regimen based on serum testosterone level***

14 Risks of Testosterone Therapy Adverse events w/ evidence Erythrocytosis Acne and Oily skin Detection of subclinical prostate CA Growth of prostate cancer Reduced sperm production and fertility Uncommon adverse events w/ weak evidence Gynecomastia Male pattern balding Growth of Breast Cancer Induction or worsening of OSA

15 Cardiovascular Debate Vigen et al. JAMA 2013 Article- Increased risk of adverse CV Outcomes Complex retrospective study with a messy data set Omitted 1,132 men from the statistical analysis Raw event rate 10% testosterone grp vs 21% non-testosterone grp Basaria et al. N Engl J Med Adverse events w/ testosterone admin 209 patients enrolled, mean age in the treatment group vs 5 in the placebo group had adverse CV events Study was shut down early due to higher incidence of CV events Xu et al. BMC Med 2013 Meta-Analysis, poor inclusion criteria Finkle et al. Plos One 2014 Compared testosterone tx to PDE-5 inhibitors

16 Cardiovascular Debate (continued) Link between normalizing testosterone and improvement in metabolic syndrome 20 years of research that has shown improved mortality for those with hypogonadism when treated with testosterone therapy Shores et al. J Clin Endo Metab overall mortality is lower in treated patients with hypogonadism (<300ng/dL) Mortality was reduced by one half in men who received testosterone therapy Muraleedharan et al. Eur J Endocrin testosterone deficiency associated with increased mortality, improved survival in men with type 2 DM.

17 FDA Warning FDA Drug Safety Communication: FDA cautions about using testosterone products for low testosterone due to aging; requires labeling change to inform of possible increased risk of heart attack and stroke with use March 2015

18 Testosterone and Prostate Cancer Average increase in PSA after starting testosterone ng/ml per year 1.4ng/mL increase or greater is considered abnormal Refer to urology Recommend checking PSA prior to starting testosterone Urology referral recommended if PSA >4.0 ng/ml or >3.0 ng/ml in high risk individuals If PSA >0.6 ng/ml at baseline then DRE and repeat PSA at 6 mos and annually If any nodules on DRE, then urology eval prior to starting testosterone

19 How do well do we do this therapy? Retrospective study looked at 10 years worth of patients who had received testosterone therapy, approx. 61, 000 males >40 years old 20% of patients treated did not meet criteria for low testosterone 50% received a follow-up testosterone level after starting therapy 40% received a follow-up PSA Patients followed by an endocrinologist or urologist were more likely to have received follow-up lab tests. Primary Care providers need to do better with follow up testing

20 Bottom Line Need additional investigation to sort out relationship between testosterone and CVD Use caution in individuals at high risk for CVD/ recent events Consider treating those with low T and metabolic syndrome/ diabetes Goal of treatment in older men should be low normal range ( ng/dl) Injectable testosterone has a peak immediately after dosing which may pose an increased risk compared to other forms- not well studied Not recommended to screen and/or treat asymptomatic men

21 In Summary Screen symptomatic men at risk for androgen deficiency Morning testosterone, reliable assay (talk to your friendly endocrinologist) Repeat if abnormal and include free and total LH/FSH, CBC and PSA at this time Monitor testosterone level at 3-6 mos and annually Shoot for ng/dl range on treatment Monitor symptom improvement More evidence needed to determine the link between CVD and testosterone therapy

22 References Bhasin S. Testosterone therapy in men with androgen deficiency syndromes: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab Jun;95(6): Vigen R, et al. Association of testosterone therapy with mortality, myocardial infarction, and stroke in men with low testosterone levels. JAMA 2013; 310: Basaria S, et al. Adverse Events Associated with Testosterone Administration. The New England journal of medicine. 2010;363(2): Finkle WD, et al. Increased risk of non-fatal myocardial infarction following testosterone therapy prescription in men. PLoS One. 2014;9 Shores M, et al. Testosterone treatment and mortality in men with low testosterone levels. J Clin Enocrin Metab Jun;97(6): Xu L, et al. Testosterone therapy and cardiovascular events among men: a systematic review and meta-analysis of placebo-controlled randomized trials. BMC Medicine. 2013;11:108. Traish, A. M. et al. (2014), Long-term testosterone therapy in hypogonadal men ameliorates elements of the metabolic syndrome: an observational, long-term registry study. International Journal of Clinical Practice, 68: Baillargeon, et al. Screening and monitoring in men prescribed testosterone therapy in the US, Public Health Rep Mar-Apr;130(2):

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