A dro r gen e R e R p e lac a e c m e e m n e t t T her e a r p a y Androgen Replacement Therapy in the Aging O j b ecti t ve v s Male

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1 Androgen Replacement Therapy in the Aging Male Thomas J. Walsh, MD, MS Department of Urology University of California, San Francisco Objectives 1. List 3 effects of androgens on normal male physiology. 2. Describe 2 controversial issues surrounding androgen replacement in the older male. 3. Outline an appropriate testosterone replacement algorithm in hypogonadal men. Androgen Effects on the Normal Male Blood-clotting, Lipids Behavior/mood Aging and Testosterone Androgen Replacement: Benefits and Risks Institute of Medicine 2003: What Have We Learned Since? When and What to Give Heart-vasodilation Liver-serum proteins Fat-reduction Muscle-anabolic Bone marrow- stem cells Body Hair Kidney-erythropoietinerythropoietin Male sex organs- maintenance Bone-growth, density 1

2 What Happens to Testosterone with Age? Age and Testosterone Levels It falls but gradually. Also known as: Male Menopause Late Onset Hypogonadism (LOH) Andropause Viropause Male Climacteric ADAM-Androgen Deficiency in the Aging Male SM Harman et al. JCEM. 86: 724, 2001 Baltimore Longitudinal Study of Aging Prospective, 40 year study to date. N=890 men evaluated Age and SHBG Levels Age and Testosterone Younger Older Bioavailable T SHBG-T Bioavailable T SHBG-T SM Harman et al. JCEM. 86: 724,

3 Aging and Testosterone Androgen Replacement: Benefits and Risks IOM 2003: What Have We Learned? When and What to Give * * Symptoms/Findings with ADAM 1. Decreased libido/erectile dysfunction 2. Mood changes, fatigue and depression 3. Memory loss 4. Decreased lean body mass and muscle loss 5. Increase in visceral fat 6. Decreased body/facial hair and skin thinning 7. Decreased bone mineral density-osteoporosis 8. Infertility and testis atrophy 9. Gynecomastia * Conditions specific to hypogonadism Androgen Replacement: Benefits : Risks Symptom/Finding Libido/erectile function Mood changes/fatigue/depression Increased body mass and muscle Decreased body/visceral fat Cardiovascular benefit Increased bone mineral density Improved cognition Evidence? /Maybe Maybe Obstructive Sleep Apnea Infertility Polycythemia CV disease Prostate Health 3

4 Institute of Medicine Statement- November 2003 What? The NIA (National Institutes of Aging) and NCI (National Cancer Institute) requested the IOM to conduct a 12-month study to: 1) Review and assess current knowledge about the risks and benefits of testosterone therapy in older men. 2) Prepare an evidence-based report and make recommendations regarding the design, safety, and ethics of clinical trials of this intervention, if warranted. Why? Due to growing concern about an increase in the number of older men using testosterone replacement in the absence of adequate scientific information about risks and benefits. Institute of Medicine Statement- November 2003 Who? The committee consisted of prominent scientists in epidemiology, endocrinology, geriatrics, urology, oncology, psychiatry and other relevant fields. And? Institute of Medicine Statement- November 2003 Critical gaps in knowledge Unclear if lower testosterone concentrations affect health outcomes in older men Evidence suggests benefits of testosterone replacement, but it is generally mixed and inconclusive Aging and Testosterone Androgen Replacement: Benefits and Risks IOM 2003: What Have We Learned? When and What to Give No definitive evidence of risk associated with replacement 4

5 Prostate Health No clear link between testosterone level and BPH Association between testosterone replacement and prostate cancer still inconclusive, but: Lower endogenous T may = worse cancer Imamoto, et al. Eur Urol 2005; 47: Isom-Batz, et al. J Urol 2005; 173: No obvious increased risk of prostate cancer in men on T replacement Meta-analysis N=651, OR 1.09 Calof, et al. J Gerontol 2005; 60: Prostate Health No evidence of cancer recurrence after treatment for organ-confined or locally advanced CaP. Agarwal, et al. J Urol 2005; 173: Ferreira, et al. Prostate Cancer Prost Dis 2006; 9: No increased risk of CaP in hypogonadal men with PIN treated with testosterone. Swerdloff, et al. Aging Male 2003; 6: Androgen Replacement and PSA Androgen Replacement: PSA and Prostate Cancer N=108 men Age >65 years Low testosterone PJ Snyder. J Clin Endocr Metab. 84: 1966, 1999 Contemporary studies have confirmed (non-comparative) Swerdloff R, et al. Aging Male 2003; 6: El-Sakka AI, et al. J Sex Med 2005; 2: Hypogonadal likely have lower PSA Thompson IM, et al. NEJM 2003; 349: Current Recommendations 1. Before Rx: PSA, DRE, voiding history. 2. If normal, consider testosterone. 3. If either abnormal, TRUS biopsy. Positive biopsy- No testosterone Negative biopsy- Consider testosterone 4. During Rx: continued monitoring q3-6 mos. Rhoden EL, et al. NEJM 2004; 350:

6 Metabolic syndrome (MS) 1. Insulin resistance 2. Obesity 3. Abnormal lipids 4. Hypertension HIM Study: 31% prevalence of DM in hypogonadal men 17% prevalence of DM in eugonadal men Mulligan T, et al. Int J Clin Pract 2006; 60: Hypogonadism Non-Diabetic men 4-fold more likely to develop MS if hypogonadal Laaksonen DE, et al. Eur J Endo 2003; 149: Cardiovascular health IOM: no clear link between T and CV outcomes Testosterone replacement may: Improve CV parameters and QOL Malkin CJ, et al. Heart 2004; 90:871-6 Improve Coronary artery vaso-reactivity Jones RD, et al. Euro J Endo 2004; 151: Kang SM, et al. Am J Cardiol 2002; 89: Does not negatively influence markers of coagulation Smith AM, et al. Eur J Endo 2005; 152: Physical function IOM: inconclusive evidence linking T and body composition; decreased T may contribute to frailty Testosterone replacement may: Improve bone mineral density and muscle mass/strength Amory JK, et al. J Clin Endocrin Metab 2004; 89: Increase lean body mass and performance and decrease fat and leptin Page ST, et al. J Clin Endocrin Metab 2005; 90: Mental function Testosterone replacement may lead to: Improvements in VERBAL and SPATIAL memory Cherrier MM, et al. J Androl 2003; 24: 568 Relationship between total/free testosterone and Alzheimers disease. Free testosterone falls more precipitously in men who develop Alzheimer s Disease Men with Alzheimer s have lower testoterone levels than age-matched controls Pike, et al. Endocrine 2006; 29:

7 Sexual function Massachusetts Male Aging Study: Serum T did not correlate with ED ED is multifactorial in older men; only 6.6% is due to hypogonadism; Only 1/3 of these men will respond to T None Mild Moderate Severe PROBABILITY Improved libido and sexual function: yes! Wang C, et al. J Clin Endo Metab 2005; 90: Testosterone plus PDE-5 inhibitors: maybe Shabsigh R. J Urol 2004; 172: Aging and Testosterone Androgen Replacement: Benefits and Risks IOM 2003: What Have We Learned? When and What to Give :When and What? 1. Assess patient symptoms. Appropriate Sx s present. 2. Measure total testosterone. If: <200ng/dL Consider Rx ng/dL Repeat Total and Free T >350ng/dL Normal; No Rx Androgen Replacement: Contraindications Known or suspected prostate cancer. Known or suspected breast cancer. Elevated hematocrit. Pre-existing existing obstructive sleep apnea. Low Free T Normal Free T Consider Rx No Rx 7

8 Available preparation Oral : What? Formula Dose Specific risk Methyltestos osteroneone Fluoxy uoxymesterone Parenteral Testosterone cypiona onate Testosterone enanthate Transderm rmal patch Testoderm rm(scrotal) Testoderm TTS Androderm Transderm rmal gel Androge ogel mg/day mg IM every 2-3 weeks High first pass inactivation on, multiple dail ily dosing, hepatotoxicity Deep intramuscu uscular injection, supraphy aphysiologi ogic peaks and troughs 4-6mg/day Scrotal: poor absorption, dail ily 5mg/day shaving 2.5-5mg/day derm rmatologica cal reactions 5gm=5 =5mg/day Transference nce to part rtner Androgen Replacement: Conclusions 1. Very appropriate for truly hypogonadal men. 2. Highly questionable for eugonadal but symptomatic older men. 3. Long, term prospective trials needed to truly define risk (benefits observed in short trials). 8

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