Hypogonadism* (män) Erytrocytos Kardiovaskulär risk

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1 Hypogonadism* (män) Erytrocytos Kardiovaskulär risk *Lågt Testosteron och symtom Stefan Arver ANOVA, Karolinska Univ Sjukhuset Inst. F Medicin/Huddinge Karolinska Institutet Endokrindagar i Umeå

2 The story about testosterone... for his work on sex hormones. (Brown-Séquard, C. The Lancet 1889; 134 (3438); ) Endokrindagar i Umeå

3 N. Engl. J. Med. 1940; 222: From this report of the practical use of testosterone in clinical medicine it is obvious that the drug is a potent one, particularly in hypogonadism in males. In this condition, its effectiveness as substitution therapy is uniformly accepted. Endokrindagar i Umeå

4 The story about testosterone (Lesser, M. N Engl J Med 1943; 228: ) Endokrindagar i Umeå

5 Testosterone in coronary heart disease Mathur A et al. European Journal of Endocrinology

6 När Testosteron Kommer på agendan undrar man Dina Associationer? Förklaring till att män dör tidigare än kvinnor Ökar risken för hjärtkärlsjukdom Styr mäns aggressivitet och gör män våldsamma Ökar sexdrift och potens Hierarkin på jobbet styrs av testosteron Endokrindagar i Umeå

7 Testosteronanvändning i USA Patterns of testosterone prescription overuse. Jasuja, Guneet; Bhasin, Shalender; Rose, Adam Current Opinion in Endocrinology, Diabetes & Obesity. 24(3): , June DOI: /MED FIGURE 1. Proportion of male Veterans receiving testosterone therapy, FY FY: Fiscal Year Data source: VA Corporate Data Warehouse. Endokrindagar i Umeå Copyright 2017 Wolters Kluwer Health, Inc. All rights reserved. Published by Lippincott Williams & Wilkins, Inc. 2

8 Low Testosterone and Increased Mortality (N >500) Studies HR (95% CI) Nature Men, n Follow-Up, y Mortality Shores, ( ) Retrospective All-cause Laughlin, ( ) Prospective CVD Khaw, ( ) Prospective 2314 of 11, All-cause and CVD Haring, ( ) Prospective All-cause 2.56 ( ) CVD Malkin, ( ) Prospective All-cause in men with coronary disease Tivesten, ( ) Prospective All-cause Menke, ( ) Prospective All-cause Vikan, ( ) Prospective All-cause Corona, ( ) Prospective CVD HR=hazard ratio; CI=confidence interval. Lunch Seminarium Endokrin Huddinge

9 Epidemiologi och observation Progression of mean IMT of common carotid artery after 4 years correlates with serum total and free testosterone Muller M et al Circulation 2004;109:2074 Mulller M et al. Circulation 2004; 109:

10 JAMA Aug 11;314(6): doi: /jama Effects of Testosterone Administration for 3 Years on Subclinical Atherosclerosis Progression in Older Men With Low or Low-Normal Testosterone Levels: A Randomized Clinical Trial. Basaria S et al Intervention Endokrindagar i Umeå

11 High Serum Testosterone Is Associated With Reduced Risk of Cardiovascular Events in Elderly Men The MrOS (Osteoporotic Fractures in Men) Study in Sweden Claes Ohlsson, MD, PHD,* Elizabeth Barrett-Connor, MD, Shalender Bhasin, MD, PHD, Eric Orwoll, MD, PHD, Fernand Labrie, MD, PHD, Magnus K. Karlsson, MD, PHD,# Östen Ljunggren, MD, PHD,** Liesbeth Vandenput, PHARMD, PHD,* Dan Mellström, MD, PHD,* Åsa Tivesten, MD, PHD Conclusion: High serum testosterone predicted a reduced 5-year risk of CV events in elderly men. (J Am Coll Cardiol 2011; 58: ) 2011 by the American College of Cardiology Foundation Testosterone Therapy Pros and Cons ESSM 2014

12 Vigen R et al. J Am Med Assoc 310(17): (2013) Endokrindagar i Umeå

13 Proportion of All Events According to Kaplan-Meier Estimation with Treatment as Time-Varying Covariate (Stabilized Inverse Probability of Treatment Weighting*) 30 no TRT TRT at 1 year at 2 years at 3 years *age, race, comorbidities: (prior MI, congestive heart failure, diabetes, renal failure, depression, posttraumatic stress disorder, hyperlipidemia, peripheral vascular disease, chronic pulmonary disease, chronic obstructive pulmonary disease, obstructive sleep apnea, hypertension, cerebrovascular disease, overweight, dialysis, ever smoker, alcohol, anemia, blood loss anemia, coagulation disorder, complicated diabetes, uncomplicated diabetes, drug abuse, fluid electrolyte disorder, human immunodeficiency syndrome or AIDS, hypothyroidism, liver disease, lymphoma, metastatic cancer, neurological disorder, paralysis, peptic ulcer disease, psychoses, pulmonary circulatory disorder, renal failure, rheumatoid arthritis, nonmetastatic tumor, and weight loss), and procedures (prior revascularization, prior catheterization, prior percutaneous coronary intervention [PCI], prior coronary artery bypass graft surgery, cardiac transplant, prior stress test, prior cardiac blood pool imaging, cardiac magnetic resonance imaging, cardiac computed tomography [CT], CT coronary angiography, prior myocardial perfusion imaging,,prior transthoracic echocardiogram, and prior transesophageal echocardiogram Endokrindagar i Umeå Data from: Vigen R et al. J Am Med Assoc 310(17): (2013)

14 Proportion of All Events (Composite of All-cause Mortality, Myocardial Infarction and Stroke) in Hypogonadal Patients (%) with or without Testosterone Replacement Therapy (TRT) no TRT TRT 25 21, , Death Myocardial infarction Stroke 0 all events Data from: Vigen R et al. J Am Med Assoc 310(17): (2013) Endokrindagar i Umeå

15 Vascular survival Testosterone, coronary artery disease and prognosis 930 men with coronary heart disease followed for 7 years Bio T >2.6 nmol/l Bio T <2.6 nmol/l Low testosterone levels are common in men with coronary artery disease and low bioavailable but not total testosterone related to impaired vascular survival (Malkin 5 februari et al Heart 2010; 96: ) 15 Days

16 Cumulative survival Cumulative survival Testosterone treatment in T2DM Cohort study (n=581) of men with T2DM followed for 6 years Low TT treated TT 300 ng/dl TT>300 ng/dl Low TT untreated Normal TT p=0.009 HR=2.0 ( ) p=0.004 HR=2.3 ( ) Months of survival Months of survival Low total testosterone (TT) associated with worse prognosis in men with T2DM. Long-term testosterone treatment assessed retrospectively was associated with improved survival in men with low testosterone. 5 februari (Muraleedharan et al. European Journal of Endocrinology 2013: )

17 Odds Ratio for Major Adverse Cardiovascular Events (MACE) in Subjects Treated with Testosterone or Placebo MACE: cardiovascular death, non-fatal myocardial infarction, stroke, acute coronary syndromes, and/or heart failure Odds ratio for MACE TRT Placebo Source MH - OR LL UL p #Events # Patients #Events # Patients Copenhagen SG, 1986 (31) 1,97 0,08 48,82 0,68 Hall et al., 1996 (34) 0,32 0,01 8,23 0,49 Sih et al., 1997 (36) 0,88 0,05 15,33 0,93 Snyder et al., 1999 (40) 2,04 0,18 23,17 0,57 English et al., 2000 (42) 3,12 0,12 80,39 0,49 Seidman et al., 2001 (47) 0,41 0,02 10,83 0,59 Steidle et al., 2003 (52) 2,83 0,11 70,27 0,53 Armory et al., 2004 (54) 3,13 0,12 80,68 0,49 Kenn et al., 2004 (56) 0,23 0,01 7,05 0,40 Svartberg et al., 2004 (60) 0,29 0,01 7,74 0,46 Brockenbrough et al., 2006 (63) 3,75 0,36 39,59 0,27 Malkin et al., 2006 (69) 2,17 0,19 25,01 0,53 Nair et al., 2006 (72) 5,70 0,26 123,78 0,27 Svartberg et al., 2008 (81) 3,16 0,12 82,64 0,49 Chapman et al., 2009 (84) 1,00 0,05 20,83 1,00 Legros et al., 2009 (85) 1,01 0,04 25,01 1,00 Aversa et al., 2010 (89) 0,08 0,00 2,07 0,13 Aversa et al., 2010 (90) 0,07 0,00 1,97 0,12 Basaria et al., 2010 (11) 13,39 0,74 240,78 0,08 Kalinchenko et al., 2010 (92) 0,21 0,01 5,15 0,34 Srinivas- Shankar et al., 2010 (93) 1,01 0,14 7,31 0,99 Ho et al., 2011 (95) 1,00 0,06 16,37 1,00 Jones et al., 2011 (96) 0,51 0,05 5,75 0,59 Kaufman et al (97) 0,87 0,04 18,48 0,93 Behre et al (99) 2,95 0,12 72,91 0,51 Hildreth et al (100) 0,15 0,02 1,53 0,11 Overall 1,01 0,57 1,77 0,96 LL: Lower limit; MH-OR: Mantel-Haenszel odds ratio; UL: Upper limit Placebo Corona G et al. Expert Opin Drug Saf, published online August 19, 2014 TS Endokrindagar i Umeå

18 Lunch Seminarium Endokrin Huddinge

19 There have been no RCTs that were large enough or long enough to determine the effects of T-replacement therapy on major adverse cardiovascular events (MACE). Additionally, there is no conclusive evidence that T supplementation is associated with increased cardiovascular risk in hypogonadal men. Endocrine Soc Guidlines 2018 Endokrindagar i Umeå

20 1. EMA Press Release Accessed [March 2018] at: errals_document/testosterone_31/recommendation_provided_ by_pharmacovigilance_risk_assessment Committee/WC pdf; 2. FDA Drug Safety EMA and FDA recommendations for CV disease risk EMA recommendations Inconsistent evidence for increased risk of CV disease following TRT 1 FDA recommendations TRT labels must specify possible increased risk of stroke and heart attack associated with TRT 2 CV, cardiovascular; EMA, European Medicines Agency; FDA, Food and Drug Administration; TRT, testosterone replacement therapy

21 Testosterone treatment in the cardiovascular system Exercise-induced ischemia: Time to 1 mm ST depression Myocardial perfusion: Perfusion of coronary territories with no stenosis QT interval: QT-interval Changes in CV surrogate measures with testosterone treatment Hemodynamics: Cardiac output Coronary artery blood flow: Blood flow and artery diameter Myocardial protection: Decreased reperfusion injury (Jones et al. Asian J Andrology (2018) 20, ; Endokrindagar Kloner et al. J i Am Umeå Coll 2019 Cardiol 2016;67:545 57) 21

22 Total testosterone (ng/dl) Study I: Dynamics of testosterone 123 male patients with AMI and 124 matched healthy controls Testosterone levels in patients after AMI compared to controls at baseline p< p=0.05 p< Day 1 Discharge 3 months 12 months Controls Time point Anne Wang 5 februari

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28 Hematocrit Testosterone Estradiol

29 Effekt av androgen receptor polymorfism på erytropoes respons av T-behandling From: Androgen Receptor Gene CAG Repeat Length and Body Mass Index Modulate the Safety of Long- Term Intramuscular Testosterone Undecanoate Therapy in Hypogonadal Men J Clin Endocrinol Metab. 2007;92(10): doi: /jc

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34 Bachman et al J Gerontology A Biol Sci Med 2014 (6): Endokrindagar i Umeå

35 Clinicians should evaluate men who develop erythrocytosis during T-replacement therapy and withhold T therapy until hematocrit has returned to the normal range and then resume T therapy at a lower dose. Using therapeutic phlebotomy to lower hematocrit is also effective in managing T treatment induced erythrocytosis Endocrine Soc Guidlines 2018 Endokrindagar i Umeå

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