Testosterone Replacement Therapy

Controversies and Answers October 16, 2013 1:00 PM – 2:15 PM Rosemont, Illinois Sponsored by pmiCME

Educational Partner

Session 4: Testosterone Replacement Therapy: Controversies and Answers Testosterone Update: Facts, Myths, Reality – Dr Guay Identification and Evaluation of the At-Risk Patient – Dr Miner Learning Objectives 1. 2. 3. 4.

Identify the signs and symptoms of hypogonadism and their clinical presentation. Identify the role of hypogonadism in diabetes, obesity, metabolic syndrome, and cardiovascular disease. Select options available to effectively treat hypogonadism. Implement monitoring strategies for patients on testosterone replacement therapy.

Faculty Martin Miner, MD Chief of Primary Care and Community Medicine The Miriam Hospital Clinical Associate Professor of Family Medicine and Urology Warren Alpert Medical School Brown University Providence, Rhode Island

Martin Miner, MD, clinical associate professor of family medicine and urology at Warren Alpert Medical School in Providence, Rhode Island, has practiced preventive and primary care medicine for more than 28 years and is currently chief of family and community medicine at The Miriam Hospital. He is the author of more than 75 publications in the areas of erectile dysfunction and cardiovascular disease, benign prostatic hyperplasia and lower urinary tract symptoms in reference to male sexuality, and hormonal replacement therapy in men. Dr Miner is president-elect of the American Society for Men’s Health, associate editor of the Journal of Men’s Health, and serves on multiple journal boards and reviews for several publications. He is currently active in several research studies on men’s health, and was the recipient of the Dean’s Teaching Excellence Award in 2003 and 2007. André T. Guay, MD, FACP, FACE Tufts University School of Medicine Boston, Massachusetts Director, Center for Sexual Function/Endocrinology Lahey Clinic Northshore Peabody, Massachusetts

André T. Guay, MD, founder and director of the Center for Sexual Function at Lahey Clinic Northshore in Peabody, Massachusetts, earned his medical degree from the New Jersey College of Medicine and Dentistry of New Jersey in Newark, then served an internship and residency in internal medicine at Saint Vincent Hospital in Worcester, Massachusetts. He continued with specialty training in endocrinology and metabolism at the Mayo Clinic in Rochester, Minnesota. Beginning as a staff physician at the Naval Medical Center in Portsmouth, Virginia, Dr Guay advanced to head of the division of endocrinology. He is affiliated with Tufts Medical School, Boston, Massachusetts, as well as serving as senior staff physician in the department of endocrinology at the Lahey Clinic Medical Center in Burlington, Massachusetts. Research interests span male infertility and sexual dysfunction to the relationship of breast cancer and androgens in women, with a current concentration on male and female testosterone deficiency. His numerous published works concern reproductive endocrinology and neuroendocrinology, and he has been principal investigator or collaborator on more than 25 related research projects since 1975. Recipient of the 2006 Lahey Clinic Research Prize, Dr Guay instructs endocrinology fellows at that institution.

Session 4

Faculty Financial Disclosure Statements The presenting faculty reports the following: Dr Miner has no financial relationships to disclose. Dr Guay has no financial relationships to disclose.

Education Partner Financial Disclosure Statement The content collaborators at Miller Medical Communications, LLC., reports the following: Lyerka D. Miller, PhD, has no financial relationships to disclose.

Suggested Reading List Bhasin S, Cunningham GR, Hayes FJ, et al; for the Task Force, Endocrine Society. Testosterone therapy in men with androgen deficiency syndromes: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2010;95(6):2536-2559. Carruthers M. Time for international action on treating testosterone deficiency syndrome. Aging Male. 2009;12(1):21-28. Dobs AS, Morgentaler A. Does testosterone therapy increase the risk of prostate cancer? Endocr Pract. 2008;14(7):904-911. Mulligan T, Frick MF, Zuraw QC, et al. Prevalence of hypogonadism in males aged at least 45 years: the HIM study. Int J Clin Pract. 2006;60(7):762-769. Malkin CJ, Pugh PJ, Morris PD, et al. Low serum testosterone and increased mortality in men with coronary heart disease. Heart. 2010;96(22):1821-1825. Traish AM, Guay A, Feeley R, et al. The dark side of testosterone deficiency: I. Metabolic syndrome and erectile dysfunction. J Androl. 2009;30(1):10-22.

Session 4

Presenter Disclosure Information

SESSION 4

The following relationships exist related to this presentation:

1–2:15pm

► Dr Miner has no financial relationships to disclose.

Testosterone Replacement Therapy: Controversies and Answers

► Dr Guay has no financial relationships to disclose.

Off-Label/Investigational Discussion ► In accordance with pmiCME policy, faculty have been asked to disclose discussion of unlabeled or unapproved use(s) of drugs or devices during the course of their presentations.

SPEAKERS Martin Miner, MD André T. Guay, MD, FACP, FACE

Learning Objectives

Testosterone Replacement Therapy: Controversies and Answers



Identify the signs and symptoms of hypogonadism and their clinical presentation



Identify the role of hypogonadism in diabetes, obesity, metabolic syndrome, and cardiovascular disease



Select options available to effectively treat hypogonadism



Implement monitoring strategies for patients on testosterone replacement therapy

André T. Guay, MD Clinical Professor of Medicine Tufts University School of Medicine Boston, Massachusetts Director, Center for Sexual Function/Endocrinology Lahey Clinic, North Shore Peabody, Massachusetts

Martin M. Miner, MD Co-Director, Men’s Health Center Chief of Primary Care and Community Medicine The Miriam Hospital Clinical Associate Professor of Family Medicine and Urology Warren Alpert Medical School Brown University Providence, Rhode Island

Drug List Generic Name  Testosterone buccal system  Testosterone cypionate  Testosterone enanthate  Testosterone pellets  Testosterone topical gel  Testosterone topical solution  Testosterone transdermal system  Testosterone undecanoate

Testosterone Update Facts, Myths, Reality Trade Name Striant Depo-Testosterone Delatestryl Testopel Fortesta, AndroGel, Testim Axiron Androderm, Testoderm Andriol (not available in the United States)

André T. Guay, MD Clinical Professor of Medicine Tufts University School of Medicine Boston, Massachusetts Director, Center for Sexual Function/Endocrinology Lahey Clinic, North Shore Peabody, Massachusetts

1

How Is Hypogonadism Defined by The Endocrine Society? 

Word Soup 

A clinical syndrome that results from failure of the testis to produce physiological levels of testosterone (androgen deficiency) and the normal number of spermatozoa caused by the disruption of one or more levels of the hypothalamic-pituitary-testicular (HPT) axis

     

AD—Androgen Deficiency Syndrome ADAM—Androgen Deficiency Syndrome in the Aging Male Andropause, or Male Menopause LOH—Late Onset Hypogonadism Low T—Low Testosterone Male Hypogonadism TDS—Testosterone Deficiency Syndrome – DEFINITION: signs and symptoms of androgen deficiency plus a biochemical level that is low or borderline (if borderline, a 3-4 month trial may be offered)

Bhasin S, et al. J Clin Endocrinol Metab. 2006;91(6):1995-2010. Grossmann M, et al. Clin Endocrinol (Oxf). 2008. Mulligan T, et al. Drugs Today (Barc). 1998;34(5):455-461. Hong BS, et al. Int J Urol. 2007;14(11):981-985. Seidman SN. Psychopharmacol Bull. 2007;40(4):205-218. Nieschlag E, et al. Eur Urol. 2005;48(1):1-4.

Bhasin S, et al. J Clin Endocrinol Metab. 2010;96(6):2536-2559.

Why Do We Need Testosterone? Advertisements Appeal To Machoism

Does everyone need to be a baseball player?

The Reality of Testosterone

Clinical Implications of Testosterone Deficiency Metabolic Syndrome

Physiological Effects of Testosterone in Male Adults        

Insulin Resistance/ Diabetes

Maintains reproductive tissues Stimulates spermatogenesis Stimulates and maintains sexual function Increases body weight and nitrogen retention Increases lean body mass Maintains bone mass Promotes sebum production, and axillary and body hair growth Stimulates erythropoiesis

Inflammation

Sexual Dysfunction

TESTOSTERONE DEFICIENCY

Hypertension

Vascular Stiffness Atherosclerosis

MORTALITY Bagatell CJ, et al. N Engl J Med. 1996;334(11):707-714.

Adapted from Maggio M, Basaria S. Int J Impot Res. 2009;21(4):261-264.

2

Dyslipidemia

Low Testosterone and Increased Mortality (N >500)

The Dilemma Is That Low Testosterone Levels Are Associated With Increased Mortality

HR (95% CI)

Nature

Men, n

Follow-Up, y

Mortality

Shores, 2006

1.88 (1.34–2.63)

Retrospective

858

8

All-cause

Laughlin, 2008

1.38 (1.02–1.85)

Prospective

794

20

CVD

Khaw, 2007

2.29 (1.60–3.26)

Prospective

2314 of 11,606

10

All-cause and CVD

Haring, 2010

2.32 (1.38–3.89)

Prospective

1954

Recent Studies

VA Puget Sound 8-year study of 858 men

Low T