Recommendations on the diagnosis, treatment and monitoring of Testosterone deficiency (TD) in adult men

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1 Recommendations on the diagnosis, treatment and monitoring of Testosterone deficiency (TD) in adult men Bruno Lunenfeld, George Mskhalaya, Svetlana Kalinchenko, Yulia Tishova, Michael Zitzmann, Stefan Arver, Abraham Morgentaler Lunenfeld B, Mskhalaya G, Zitzmann M, Arver S, Kalinchenko S, Tishova Y,Morgentaler A. Recommendations on the diagnosis, treatment and monitoring ofhypogonadism in men. Aging Male Feb 6:1-11. (open Access) 1

2 Level of evidence categorized according to the US Department of Health and Human Services, Public Health Service, Agency for Health Care Policy and Research (1992).

3

4 Recommendations EAU Guideline recommendations have been graded in accordance with the Oxford Centre for Evidence-Based Medicine levels of evidence. 4

5 Recommendation 1.1 Definition Hypogonadism (testosterone deficiency) in adult men is a clinical and biochemical syndrome associated with low level of testosterone, which may adversely affect multiple organ functions and quality of life.( in a person who has had normal pubertal development and as a result developed normal male secondary sex characteristics ) Although the clinical significance of hypogonadism in adult men is becoming increasingly recognized, the extent of its prevalence in the general population is underappreciated. A large number of men with hypogonadism remain undiagnosed and untreated [5].

6 Recommendation 2.5 Clinical Diagnosis: Physical examination Weight, height, BMI and waist circumference should also be measured, since symptoms and signs potentially indicative of TD in men include height loss, reduced muscle bulk and strength and increased body fat, in particular abdominal fat accumulation In men waist circumference best predictor of visceral fat: with every cm more, 6.8 cm 2 more visceral fat 6

7 Recommendation 4.1 Laboratory Diagnosis In patients at risk or suspected of TD, a thorough physical and biochemical work-up is recommended (Level 2, Grade A). The key laboratory tests to confirm the diagnosis of TD are serum total and free testosterone. The two forms of hypogonadism (primary and secondary) have to be differentiated (LH levels),as this has implications for patient evaluation and treatment and makes it possible to identify patients with associated health problems and infertility. (1b B) Note should be made that transient decreases of serum T levels can occur, due to acute illnesses and this should be excluded by careful clinical evaluation and repeated hormone measurement. (at least on two occasions) with a reliable method 7

8 Recommendation Laboratory Diagnosis The diagnosis of testosterone deficiency should be restricted to men with persistent symptoms suggesting hypogonadism Testosterone should be measured in the morning before 11.h00 hours in the fasting state. Total testosterone assessment should be repeated at least on two occasions with a reliable method. 8

9 Recommendation 4.4 Laboratory Diagnosis There are no generally accepted lower limits of normal TT, however, there is a general agreement that symptoms of testosterone deficiency increase when TT levels are below 12.1 nmol/l (350 ng/dl) 9

10 Recommendation Laboratory Diagnosis The diagnosis of testosterone deficiency should be restricted to men with persistent symptoms suggesting hypogonadism Testosterone should be measured in the morning before 11.h00 hours in the fasting state. Total testosterone assessment should be repeated at least on two occasions with a reliable method. 10

11 Recommendation Laboratory Diagnosis In addition, in men with: - Total testosterone levels close to the lower normal range (8-12 nmol/l), the free testosterone level should be measured to strengthen the laboratory assessment. - Suspected or known abnormal sex hormonebinding globulin (SHBG) levels, free testosterone should also be included 11

12 (TERMINATOR) Abuse Lack of use

13 Recommendation 6.1: Body composition and mobility Meta-analyses of randomized trials in middle-aged and older men have demonstrated the beneficial effects of TRT in reducing fat mass (Level 1a, Grade A) with a significant increase in lean body mass and grip strength A recent meta-analysis by Corona TRT was associated with a reduction of fat mass and HbA1c in both controlled and uncontrolled trials (Level 1a, Grade A) 13

14 The penis does not obey his master s command when his master wants to have an erection, but it erects itself free and easy during his master s sleep. The penis almost seems to have its own brain Leonardo da Vinci B.Lunenfeld 14

15 Are aging men still entitled to sex?? B.Lunenfeld 15

16 Recommendation 15.1: Treatment and delivery systems Preparations of aromatizable testosterone or testosterone esters should be used. Currently available intramuscular, subdermal, transdermal, oral and buccal T preparations are safe and effective (Level 1b, Grade A). Short-acting TRT preparations may be preferred over the long-acting depot preparations in the initial treatment of patients with TD. 16

17 Recommendation 15:2 Treatment and delivery systems For the present time, the treatment goal with TRT is to maintain serum T levels in the normal range. Sustained supra-physiological serum T levels should be avoided Testosterone undecanoate is available as a long-acting intramuscular injection (with intervals of up to 3 months). This long period of action ensures a normal testosterone serum concentration for the entire period, but the relatively long wash-out period may cause problems if complications appear* Wang C, et al. Pharmacokinetics and safety of long-acting testosterone undecanoate injections in hypogonadal men: an 84-week phase III clinical trial. J Androl (5): 17 p

18 Safety considerations Men with significant erythrocytosis (hematocrit >52%) (,54%) should not be started on TRT (Level 3, Grade A), Severe untreated obstructive sleep apnoe should not be started on TRT (Level 3, Grade B), Untreated severe congestive heart failure should not be started on TRT (Level 3, Grade B) Class IV without prior resolution of the co-morbid conditions. Prostate cancer Male breast cancer Male infertility-active desire to have children 18

19 Safety considerations Without prior resolution of the co-morbid conditions: Men with significant erythrocytosis (hematocrit >52%) should not be started on TRT (Level 3, Grade A), Severe untreated obstructive sleep apnoe should not be started on TRT (Level 3, Grade B), Untreated severe congestive heart failure should not be started on TRT (Level 3, Grade B). 19

20 B.Lunenfeld 20

21 THANK YOU 21

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