Men s Health and Metabolic Syndrome

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2 Men s Health and Metabolic Syndrome 時間 :2015 年 6 月 28 日 ( 星期日 ) 上午 地點 : 台北國賓大飯店二樓四香園 ( 台北市中山北路二段 63 號 ) 主辦單位 : 台灣男性學醫學會台灣性功能障礙諮詢暨訓練委員會協辦單位 : 台灣拜耳 ( 股 ) 公司教育積分 : 外科 10 分 泌尿科 4.5 分 家醫科乙類 3 分 Time Topic Speaker Moderator 08:30-09:00 Registration ALL 09:00-09:10 Opening 黃志賢理事長 09:10-09:40 Hypogonadism and Metabolic Syndrome 杜思德醫師 黃志賢理事長 09:40-10:10 Evidence Based Review of Longlasting Testosterone Supplement 廖俊厚醫師 陳順郎醫師 10:10-10:40 Benefit or Risk in Testosterone Supplement 劉家駒醫師 林永明醫師 10:40-11:00 Break 11:00-11:30 Hypogonadism Treatment with Longlasting Testosterone: Case Sharing 陳煜醫師 吳季如醫師 11:30-12:00 Patient-Centered Care in Testosterone Replacement Therapy 簡邦平醫師 12:00-12:30 Discussion and Closing 吳季如醫師

3 講師簡介 :( 依出場序排列 ) 杜思德醫師彰化基督教醫療財團法人鹿港基督教醫院院長彰化基督教醫療財團法人鹿港基督教醫院內分泌新陳代謝科主治醫師 廖俊厚醫師天主教耕莘醫院泌尿外科主任台大醫院泌尿部兼任主治醫師輔仁大學泌尿學科主任輔仁大學泌尿科專任副教授暨教育部部定副教授 劉家駒醫師 衛生福利部屏東醫院泌尿科主任 高雄醫學大學助理教授 陳煜醫師 林口長庚泌尿科主治醫師 長庚紀念醫院助理教授 簡邦平醫師高雄榮民總醫院泌尿外科主治醫師高雄榮民總醫院基礎醫學研究科主任國立陽明醫學院醫學系副教授

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11 Evidence Based Review of Long-lasting Testosterone Supplement Indications and Contraindications 104/6/28 Chun-Hou Liao 2015 EAU guideline Benefits Preparations 2015 EAU guideline 2015 EAU guideline Expert Opin. Pharmacother. (2014) 15(13): Expert Opin. Pharmacother. (2014) 15(13):

12 BMI Weight (kg) overall sample including uncontrolled and placebo-controlled trials Expert Opin. Pharmacother. (2014) 15(13): in uncontrolled trials Expert Opin. Pharmacother. (2014) 15(13): Waist circumference (cm) Glycemia (mmol/l) in uncontrolled trials Expert Opin. Pharmacother. (2014) 15(13): in uncontrolled trials Expert Opin. Pharmacother. (2014) 15(13): HbA1C (%) HOMA index in uncontrolled trials in placebo-controlled studies in uncontrolled trials Expert Opin. Pharmacother. (2014) 15(13):

13 Total Cholesterol HDL-cholesterol (mmol/l) in uncontrolled trials Expert Opin. Pharmacother. (2014) 15(13): in uncontrolled trials Expert Opin. Pharmacother. (2014) 15(13): Triglycerides (mmol/l) Systolic blood pressure (mmhg) in uncontrolled studies Expert Opin. Pharmacother. (2014) 15(13): in uncontrolled studies Expert Opin. Pharmacother. (2014) 15(13): Diastolic blood pressure (mmhg) Erectile function standardized mean in uncontrolled studies Expert Opin. Pharmacother. (2014) 15(13): In uncontrolled studies Expert Opin. Pharmacother. (2014) 15(13):

14 IPSS score Lumbar BMD In uncontrolled studies Expert Opin. Pharmacother. (2014) 15(13): In uncontrolled studies Expert Opin. Pharmacother. (2014) 15(13): Depressive symptoms standardized mean Summary of the clinical effects In uncontrolled studies Expert Opin. Pharmacother. (2014) 15(13): Expert Opin. Pharmacother. (2014) 15(13): Long-Term Testosterone Treatment in Elderly Men with Hypogonadism and Erectile Dysfunction Reduces Obesity Parameters and Improves Metabolic Syndrome and Health-Related Quality of Life J Sex Med 2014;11: J Sex Med 2014;11:

15 J Sex Med 2014;11: Obesity Research & Clinical Practice (2014) 8, e339 e349 Obesity Research & Clinical Practice (2014) 8, e339 e349 Obesity Research & Clinical Practice (2014) 8, e339 e349 International Journal of Endocrinology Volume 2014, Article ID , 9 pages International Journal of Endocrinology Volume 2014, Article ID , 9 pages 12

16 Korean J Urol 2015;56: World J Urol. DOI /s z 13

17 BACKGROUND Benefit or Risk in Testosterone Supplement ( 日 ) 劉家駒醫師 CHIA-CHU LIU MD, PhD 高雄醫學大學附設中和紀念醫院泌尿科高雄醫學大學醫學院醫學系泌尿學科行政院衛生福利部屏東醫院泌尿科 Testosterone (T) in healthy men reaches its highest levels at approximately age 30, after which it starts to gradually decline at a rate of 1% to 2% annually. In past decade, a significant increase in the use of TRT by men over 40 was witnessed. (In US, 0.81% in 2001 to 2.91 % in 2011, threefold increased) (Layton et al, J Clin Endocrinol Metab 2014) (Baillargeonet al, JAMA Intern Med 2013) The benefit and risk of TRT was still under greatly debated and concerned. EVIDENCE-BASED EFFICACY OF TRT Potential Benefits of TRT Potential benefits Libido and erection function restoration Energy increasing Mood improvement Body composition improvement Bone mineral density stabilization/increasing AACE Hypogonadism Task Force. Endocr Pract 2002;8: Bhasin et al., J Clin Endocrinol Metab 2006;91: Nieschlag et al., Eur Urol 2005;48:1-4. Physical Psychological Sexual An extensive Medline, Embase, and Cochrane search was performed from January 1, 1969 up to July 1, Testosterone supplementation (TS) vs placebo A total of 29 randomized placebo-controlled trials were included. n=1,930 subjects with a mean follow-up of 27 weeks. TS+ PDE5i vs Placbo+ PDE5is A total of 5 randomized placebo-controlled trials were included. PDE5is on sexual function before and after TS A total of 7 uncontrolled studies were included. n=894 subjects with a mean follow-up of 12 weeks. (Corona et al, J Sex Med 2014) (Corona et al, J Sex Med 2014) 14

18 (Corona et al, J Sex Med 2014) (Corona et al, J Sex Med 2014) An literature search through Medline and Cochrane library was performed from January 1, 2000 up to November 20, A total of 16 randomized placebo-controlled trials were included in the analysis. (n=944) The duration of the intervention was from 6 to 52 weeks (Corona et al, J Sex Med 2014) (Amanatkar et al, Ann Clin Psychiat 2014) (Amanatkar et al, Ann Clin Psychiat 2014) (Amanatkar et al, Ann Clin Psychiat 2014) 15

19 (Amanatkar et al, Ann Clin Psychiat 2014) (Amanatkar et al, Ann Clin Psychiat 2014) A total of 29 randomized placebo-controlled trials were included. (n=1083) 625 were randomized to T, 427 to placebo (P) and 31 to observation (control group). Mean age: 64.5 years. mean serum testosterone: 10.9 nmol/ l (Isidori et al, Clin Endocrinol 2005) 16

20 (Ottenbacher et al, J Am Geriatr Soc. 2006) TRT in patients with metabolic syndorme A total of 9 RCTs (Corona et al, Best Pract Res Clin Endocrinol Metab 2013) 17

21 TRT in patients with type 2 Diabetes Mellitus Potential risks of TRT Cardiovascular risk? Risk of prostate cancer? Progression of BPH? 18

22 An extensive Medline, Embase and Cochrane search was performed from January 1969 up to January A total of 75 randomized placebo-controlled trials were included patients were randomized to TRT and 2448 to placebo group. Mean trial duration: 34.8 weeks. The mean age: 59.9 years The mean baseline T : 11.2 nmol/l (Corona et al, Expert Opin Drug Saf 2014) Saturation model of prostate growth with serum testosterone concentration The saturation point : about ng/dl (Morgentaler et al,j Urol 2009) (Morgentaler et al, Eur Urol 2009) (Dupree et al, Nat. Rev. Urol.2014) 19

23 Prostate cancer: Short term trial (<12 months): Medline (1966 to Augest 2013), Embase (1974 to Augest 2013) and Cochrane Controlled Trials Register databases were searched. A total of 22 randomized placebo-controlled trials (RCTs) were included in the analysis: (N=2351) 11 RCTs compared testosterone with a placebo over the short term (<12 months). 11 RCTs compared testosterone with a placebo over the long term (12 36 months). (Cui et al, Prostate Cancer Prostatic Dis 2014) Prostate cancer: Long term trial (12-36 months): The Medline (1966 to October 2012), Embase (1974 to October 2012), and Cochrane Controlled Trials Register databases were searched. A total of 16 RCTs were included in the analysis: 7 RCTs compared androgen with a placebo over the short term (<12 mo) 9 RCTs compared androgen with a placebo over the long term (12 36 mo). ( Cui and Zhang, Eur Urol 2013) short term (<12 mo) PSA level short term (<12 mo) IPSS Prostate volume Qmax 20

24 long term (12 36 mo) long term (12 36 mo) PSA level IPSS Prostate volume Qmax (Fernandez-Balsells et al, J Clin Endocrinol Metab. 2010) (Jones et al, Sex Med Rev 2015) AUA position p statement on testosterone therapy Hypogonadism: defined as biochemically low testosterone levels in the setting of a cluster of symptoms which may include reduced sexual desire (libido) and activity, decreased spontaneous erections, decreased energy and depressed mood. Testosterone therapy : an appropriate treatment for hypogonadism after full discussion of potential adverse effects. not appropriate in patient absent of hypogonadism should not be offered to men with normal testosterone levels never a treatment for infertility The optimal follow-up of men on testosterone therapy has not been defined, but should include measurement of testosterone level, PSA and hematocrit. Other patient-specific measures may be appropriate. (Board of Directors, February 2014) TRT MONITORING Factors Frequency Special comments DRE PSA AUA / IPSS score Baseline, 3, and 6 months Annually then Baseline, 3, and 6 months Annually then Baseline, every 6 to 12 months then Biopsy if abnormal at baseline and during TRT Consult urologist if > 4.0 ng/ml Consult urologist if > 19 OSA/hypoxia Baseline, needed then If yes, reduce dose Breast examination Hgb and Hct Baseline and follow-up Baseline, 3, and 6 months Annually then Stop TRT if Hct > 50% (Bhasin et al, J Clin Endocrinol Metab 2010) (Wang et al, Eur Urol 2009) 21

25 CONCLUSION (1): Current clinical guidelines suggest TRT should be performed only in men with consistent symptoms and signs and unequivocally low serum testosterone levels. The potential benefits of TRT in hypogonadal men included restoration of sexual function, improvement of mood and body composition, increasing muscle strengths and bone mineral density, and improvement of metabolic parameters in subjects with commitant DM and/or MetS. CONCLUSION (2): Current literature reviews did not support TRT in hypogonadal men will increase risks of cardiovascular diseases, prostate cancer and progression of BPH. However, TRT would result in a significant increase of hemoglobin and hematocrit levels. It should be kept in mind in clinical practice especially performing TRT in subjects with older age or higher cardiovascular risk. Further large longitudinal, placebo-controlled, randomized studies are still needed to clarify the real effects of TRT on cardiovascular and prostatic health. THANK YOU FOR ATTENTION! 22

26 Hypogonadism Treatment with Long-lasting Testosterone: Case Sharing Yu Chen Department of Urology, Chang Gung Memorial Hospital, Chang Gung University, Taiwan According to the IPASS (An International, multicenter, Post-Authorisation Surveillance Study on long-acting-intramuscular TU conducted at 155 centers in 23 countries in Europe, Asia, Latin America, and Australia) and others studies, scores of mental and psychosexual functions (libido, vigor, overall mood, and ability to concentrate) improved markedly after long-lasting testosterone treatment. On the other hand, mean waist circumference, blood pressure and lipid parameters were altered in a favorable and significant manner too. The sexual desire/libido, erectile dysfunction of the patients improved too with TU therapy. Adverse events and adverse drug reactions (ADRs) were mostly mild to moderate. The most common ADRs were increase in hematocrit, increase in PSA, and injection site pain. We will share our experience of case with long-lasting testosterone treatment. 23

27 Outlines Patient-Centered Care in Testosterone Replacement Therapy Select right person for therapy Patient-centered care Communication 簡邦平醫師國立陽明大學醫學院副教授 Sexual Health Training for Post-Graduate Physicians Treatment-Seeking and Medication Adherence Communications: professionals, patients and partners Education: professionals, patients and partners Clinical assessment Clinical management Administrative skills Research skills Parish Ethical, Socio-cultural and Educational Aspects of Sexual Medicine in Sexual Medicine 3rd ed. Severity and distress of Disease 1. Patient and female partner 2. Natural course of disease 3. Psychosocial obstacles 4. Medical resources Cost-effectiveness of Medication 1. Resolution of symptoms 2. Expectation 3. Cost concern 4. Safety concern 5. Convenience Algorithm for TRT 診斷男性荷爾蒙低下症 Determining TT levels in men suggesting TDS Start TRT (at least 3-6 months) 抽血檢查睪固酮不足 : 最好空腹 2. 必要時再測一次 : AND 有相關的症狀或疾病 nmol/l ng/ml ng/dl Evaluating the response and continuing TRT EAA, ISA, ISSAM Mild <12 <3.40 <340 EAU, ASA, ISSM Severe <8 <2.31 <231 ES <10.4 <3.00 <300 AACE 7 <2.00 <200 24

28 Clinical diagnosis Symptoms Erectile dysfunction Decreased muscle mass and strength Increased body fat Decreased bone mineral density and osteoporosis Depressed mood Decreased libido None of these symptoms individually are specific to a low androgen state Endocrine guideline recommendations: one or more of these symptoms must be corroborated with a low serum T level (Level 3, Grade A) S SHBG T Total Testosterone CAG Androgenreceptor CAG-repeats Mohit Khera, MD Baylor College of Medicine, USA Michael Zitzmann, MD University clinics Muenster, Germamy Diagnosis of Late-Onset-Hypogonadism: Biochemical + Symptoms and Signs 1: Patient with a normal testosterone level and is symptomatic Androgen receptor CAG repeat length may be related to clinical effects of testosterone Emphasizes the important of the symptoms of TDS (classical, obesity, depression and osteoporosis) Emphasizes the possible relationship between T and metabolic syndrome 2: Patient with a low testosterone level and is asymptomatic Symptoms oftestosteronedeficiencyarenot digital: simply YES or NO. There are sympton thresholds. 434 Men (Age years) n= TT thresholds to identify TD: ng/dl(12 14-nmol/L) Two T tests were generally obtained but not always required Some experts did not require morning testing in men 50 yrs All but one expert would consider a trial of TThto a symptomatic man with TT within the normal range Recent studies suggesting increased CV risk with T therapy were not found to be credible Total Testosterone (nmol/l) Loss of libido** Loss of vigour** Obesity ** Feeling depressed** Sleep disturbances* Hot flushes** Erectile Dysfunction* Lacking concentration* Diabetes mellitus type 2** Increasing prevalence of symptoms with decreasing testosterone concentrations Morgentaler A, et al., J Sex Med2014;11: **p 0,001 *p < 0,005 Zitzmann M et al. J Clin Endocrinol Metab 91(11): (2006) 25

29 Time until the onset of the effects of testosterone substitution lean mass fat mass waist circumference Saad, Zitzmann et al. EJE 2011 Saad F et al., Eur J Endocrinol 2011;165: 評估問卷 Aging Males Symptoms scale (AMS) Androgen Deficiency in Aging Males (ADAM) Variables Libido Erection/ejaculation Quality of life Depression Erythropoiesis Lipids Insulin sensitivity Fat mass, muscle strength Insulin sensitivity PSA Bone Onset At 3 weeks, plateauing at 6 weeks Up to 6 months 3-4 weeks 3-6 weeks 3 months, peaking at 9-12 months After 4 weeks, maximal after 6-12 months 3-12 months 3-4 months, stabilize at 6-12 months 3-12 months Plateauing at 12 month After 6 months 1. General well-being 2. Joint pain and muscular ache 3. Sweating 4. Sleep problems 5. Tiredness 6. Irritability 7. Nervousness 8. Anxiety 9. Lacking vitality 10. Decreased muscular strength 11. Depression Burn out feelings 14. Reduction of beard growth 15. Decreased sexual performance 16. Reduced sleep related erections 17. Low libido 1. Low libido 2. Lack of energy 3. Decrease in strength 4. Loss of height 5. Decreased enjoyment of life 6. Sadness 7. Sexual problems 8. Reduced sport performance 9. Tiredness after dinner 10. Reduced work performance Saad F et al., Eur J Endocrinol 2011;165: Corona G, et al., J Sex Med 2011;8: Dimensions for patient-centered care Respect for patient preferences, values, and expressed needs Information, education, and communication Coordination and integration of care and services Emotional support Physical comfort Involvement of family and close others Continuity and transition from hospital to home Access to care and services 跟病患溝通的概念 男性荷爾蒙作用是全身性的, 讓你有體力動, 減少體內脂肪 減重的三要素 : 少吃 多動 補充男性荷爾蒙 男性荷爾蒙增加情慾, 對勃起硬度幫助不大, 有需要應該加服壯陽藥 ( 樂威壯 威而鋼 犀利士 ) 荷爾蒙補充治療至少需三個月才能產生效果, 治療愈久效果愈好 Rathert et al., Medical Care Research and Review 2012;70:

30 與病患溝通 : 醫師的態度宜避免 看起來不易親近 逃避眼睛接觸 自己忙著作紀錄 允許諮詢被打斷 忽略病患的暗示或問題 使用複雜的醫學名詞 忽略病患的症狀 做其他事 同理心與開放式問題 這是常見的疾病, 很多人有這樣的困擾 適度的補充治療, 有些病患會有明顯地改善 你最近有注意到身體 行為或想法有哪些改變? 你的家人或同事有沒有注意到你的變化? 資源 提醒病患 提昇專業形象 節省說明時間 空間 獨立空間 明亮乾淨 沒有閒雜人自由進出 關手機 泌尿科醫師照顧男性健康 A holistic approach to men s health Metabolic syndrome Testosterone T Erectile dysfunction P Diabetes mellitus Cardiovascular diseases Prostate Disease ED Hypertension Diabetes Dyslipidemia BPH/LUTS Depression Testosterone deficiency Obesity Metabolic syndrome Unhealthy lifestyle Shabsigh, et al., lnt J Clin Pract. 2008; 62:

31 Conclusions Patient centered care is the right care, high quality care and the most cost effective care for patient Patient-centered care promotes medication adherence and lead to improved health outcomes in men who receive TRT 28

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