MEN S HEALTH UNDERSTANDING LOW TESTOSTERONE

Transcription

1 MEN S HEALTH UNDERSTANDING LOW TESTOSTERONE

2 jectives: iscuss the importance of Testosterone in Men s Health iscuss the prevalence of Hypogonadism in various patient opulations entify the clinical manifestations of Hypogonadism ssess the barriers to diagnosis and management of Hypogonad eview the treatment options for Hypogonadism hy should YOU be concerned? What can YOU do to increase wareness and comfort in Men s Health?

3 pogonadism haracterized by: Deficiency in serum testosterone (T) levels ± changes in receptor sensitivit to androgens lso known as: Testosterone Deficiency Syndrome (TDS) Late-onset Hypogonadism (LOH) Low Testosterone (Low T) ormerly termed: Andropause

4 POGONADISM: valence ical Manifestations orbidities

5 hat Percentage of Canadian Men between the Ag f have Low T? A. 5 10% B % C % D %

6 valence of Hypogonadism Crude prevalence rate in Canada: 25% of men aged 40 to 82 years are biochemically testosterone deficient. <10% of affected men receive T therapy

7 valence of Hypogonadism: HIM Study 1 k MF et al. Int J Clin Pract. 2006; 60:762-9.

8 ical Manifestations 1,2 Mild Severe Decreased libido Decreased vitality Fatigue Mood changes Insomnia Anemia Delayed ejaculation Flushes Erectile dysfunction Decreased muscle mass Increased visceral body fat Testicular atrophy Weakness Osteopenia/osteoporosis Loss of facial, axillary and pubic hair Clin Endocrinol Metab. 2004; 89: al. J Clin Endocrinol Metab. 2006;91: Manifestations may present alone or in combination

9 ical Conditions Associated with Testosterone ciency 1,2 ype 2 diabetes mellitus Metabolic syndrome Chronic obstructive pulmonary disease Osteoporosis or low trauma fracture at a young age Treatment with opioids, glucocorticoids or ketoconazole End stage renal disease and maintenance hemodialysis nfertility J Clin Endocrinol Metab. 2006;91: l. CUAJ. 2010;4: Recommendation to screen in new Canadian Diabetes G ith these clinical conditions have high prevalence of low testosterone therefore measurement of testost ended

10 adian Diabetes Association Guidelines (CDA) 201

11 POGONADISM: essment & Diagnosis

12 essment aluate patient history and symptoms mplete Androgen Deficiency in Aging Males (ADAM) estionnaire der a serum Testosterone test

13 ogonadism Symptoms Cluster ecreased lean body mass, increased ceral fat, decreased BMD,decreased body hair Changes in mood, decreases in intellectual activity, cognitive functions, fatigue, depressed mood and irritability Sleep disturbances Libido & erectile quality and frequency rdloff R, Behre HM et al. The Aging Male 2005;8(2):56-8.

14 M Questionnaire 1 sitive answer represents Yes to questions 1 or 7, or any 3 other questi NO 1. Do you have a decrease in libido (sex drive)? 2. Do you have a lack of energy? 3. Do you have a decrease in strength and/or endurance? 4. Have you lost height? 5. Have you noticed a decreased enjoyment of life? 6. Are you sad and/or grumpy? 7. Are your erections less strong? 8. Have you noticed a recent deterioration in your ability to play sports? 9. Are you falling asleep after dinner? 10.Has there been a recent deterioration in your work performance? l. Metabolism. 2000;49:

15 ms of Circulating Testosterone y: SHBG low T with either cft or BT

16 Slide 15 A5 Title is 40pt and not all capitalized There is a shade on the green box below - reflection of the Confirm low T with either cft or BT Please capitalize Low T Author, 3/25/2013

17 asurement Tests For Testosterone (T) easured Bioavailable Testosterone (BT) is the gold standard Ammonium sulphate precipitation correlates well with symptoms of TDS 1 measured BT is unavailable or unaffordable, acceptable lternatives are 2,3 : Total Testosterone (TT) or Calculated free T (cft) or Calculated bioavailable T (cbt) Free calculator for cft and cbt 4 : ttp:// t al. J Clin Endocrinol Metab. 2007;92: , et al. J Clin Endocrinol Metab. 1999;84: t al. CUAJ. 2010;4: Society for The Study of the Aging Male. Free & Bioavailable Testosterone calculator. Accessed March 29, 2010.

18 tosterone Deficiency Syndrome (TDS): Diagnostic luation History and physical (symptoms and signs) Morning Total T Low T < nmol/l Normal T Exclude reversible illness, drugs, nutritional deficiency Repeat T [use cft or BT If suspect altered SHBG) LH+FSH SFA (if fertility issue) Follow up Confirmed low T [e.g. Total T < nmol/l; or cft or BT <normal (e.g. free T < nmol/l, BT < 4 nmol/l)] Low T, low or normal LH+FSH (2 ) Low T, high LH+FSH (1 ) Normal T, LH+FSH Prolactin, iron, other pituitary hormones, MRI [under certain circumstances] Karyotype [Klinefelter syndrome] sin S et al. J Clin Endocrinol Metab 2010; 95:

19 t-off Values For Normal T lues vary between laboratories o equipment standardization ecommendations Consistently employ the same local laboratory Achieve awareness of: Accuracy Precision Definition of normal values

20 HAT IF THE PATIENT HAS SYMPTOMS BUT IS LOW OR BORDERLINE?

21 /Borderline T peat T lus, measures of: SHBG Luteinizing hormone (LH), Follicle-stimulating (FSH) Prolactin ther tests/serum markers that may be included: Complete blood count (CBC) Ferritin Thyroid-stimulating hormone (TSH) Prostate-specific antigen (PSA) Digital rectal exam (DRE) onsider a 3 month trial if patient is low normal with symptoms

22 TREATMENT MONITORING SAFETY

23 eria for Treatment Signs or symptoms Diagnosis Biochemical evidence

24 mented Benefits of Treatment nced: rall health/survival ngth al desire/erectile function rgy tional well being improve some symptoms of MetS nition e mineral density emic control iovascular health ced: y fat

25 osterone Replacement Therapy (TRT) als Symptom improvement Achievement of physiological T levels veral safe and effective formulations available

26 sterone Formulations in Canada ame Trade Name Dosage ular Injections - Supply issues cypionate Depo-testosterone mg every 2 weeks (400 mg max per month) enanthate Delatestryl mg every 1-4 weeks Advantage(s)/ Disadvantage(s) Effective Long-acting Supraphysiologic T Waning effect (2-3 weeks) ations Generic formulations available undecanoate als Andriol 3 Convenient pms-testosterone mg daily divided in 2 doses a Absorption issues Supraphysiologic DHT patch Androderm or 5 mg patch applied daily gels AndroGel 6 Testim g daily solution Axiron 60 mg daily in Appendix A Consistent T levels Visibility Significant skin reactions Consistent T levels Minor skin reactions Secondary exposure Consistent T levels Minor skin reactions Secondary exposure

27 osterone Blood Level According to the Mode inistration IM Injection or sc q 2 weeks the day before the injection Skin patch q 24 hours measured any time Gel q 24 hours measured any time

28 Effect of Food on Absorption of Testosterone ecanoate 1 sterone Undecanoate should be taken with a normal meal or breakfast to ve proper T levels nograph: Andriol (testosterone undecanoate capsules) 40 mg. Kirkland, Québec: Schering-Plough Canada Inc.; 2008.

29 line of Symptom Improvement 1 Enhanced libido Improved emotional well-being Symptom Improvement Increased energy Reduced ED Increased strength Enhanced BMD Improved cognition Enhanced cardiovascular health Decreased body fat Improvement in some components of MetS Duration of Treatment (months) lic Syndrome l. CUAJ. 2010;4:

30 Effects of Testosterone Formulations f testosterone products may have side effects Reported Side Effects for Testosterone Products 1,2,3,4 ication Site Reaction: Irritation, Redness, Rash High Blood Pressure Increased RBC Count ged Prostate Prolonged or Painful Erection ge in Mood / Depression Aggression / Aggressive Behaviour Disturbances st Enlargement Loss / Baldness Breast Pain Weight Gain Dizziness ache g Information: Depo-Testosterone (testosterone cypionate injection USP, Sterile Solution) 100 mg/ml. Kirkland, Québec: Pfizer Canada Inc.; g Information: Delatestryl (testosterone enanthate, Solution for Injection) 200 mg/ml. Mississauga, Ontario: Theramed Corporation; onograph: Andriol (testosterone undecanoate capsules) 40 mg. Kirkland, Québec: Schering-Plough Canada Inc.; onograph: pms-testosterone (testosterone undecanoate capsules) 40 mg. Montréal, Québec: Pharmascience Inc.; 2009.

31 n-response n-response may be indicative of: Compliance Poor absorption (oral) Insufficient dose Unsatisfactory formulation Symptoms unrelated to TDS D patients who fail T or PDE5i alone: Consider T plus PDE5i ong-term lack of response: Consider referral to a specialist (endocrinologist/urologist)

32 itoring: Recommendations for Follow-Up seline Testosterone measurement 1,2 Hematological assessment 1,2 DRE & PSA 1,2 epeat q 3 months over first year, then annually 1,2 Maintain testosterone in lower to middle range expected in young adults 1,2 Swerdloff R, Behre HM et al. The Aging Male 2005;8(2):56-8. nningham GR, Hayes FJ et al. J Clin Endocrinol Metab 2006;

33 traindications to Treatment spected or confirmed carcinoma of the prostate or breast 1,2 ignificant polycythemia (hematocrit>50%) 1,2 ntreated sleep apnea 1,2 evere heart failure (eg, class III or IV) 1,2 evere symptoms of lower urinary tract obstruction 1,2 linical evidence of bladder outflow obstruction 1 ndiagnosed prostate nodule or induration 2 nexplained elevation in PSA 2, Swerdloff R, Behre HM et al. The Aging Male 2005;8(2):56-8. nningham GR, Hayes FJ et al. J Clin Endocrinol Metab 2006;

34 QUESTIONS ABOUT THE PROSTATE?

35 state Safety: Historical Review rrent evidence no increase in PCa rates in clinical trials of TRT in normal men or men at increased risk for PCa no relationship of PCa risk with serum testosterone levels no reduced risk of PCa in men with low testosterone ler, A. Euro Urol 2006;50:

36 cts of Testosterone on Prostatic Outcomes ta-analysis of 51 testosterone studies significant effect on prostate cancer incidence significant effect on the need for prostate biopsy significant effect on rate of PSA levels > 4 ng/ml or significant rease in PSA during treatment > 1.4 ng/ml above baseline significant effect on a composite prostate endpoint alsells M et al. J Clin Endocrinol Metab 2010;95:

37 clusion osterone Deficiency Syndrome (TDS) is a common condition has an impact on individuals Quality of Life ers have an important role to play in educating and increasing reness in Men s Health Payers can engage with their employers and create an opportunity for incre awareness Support Health Learning Days in the workplace Increase access to learning - bring in healthcare professionals / screening clinic the workplace

38 QUESTIONS AND ANSWERS

39 THANK YOU FOR YOUR PARTICIPATION