Testosterone, Growth Hormone and Bioidentical Hormones Prescription Issues

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1 Testosterone, Growth Hormone and Bioidentical Hormones Prescription Issues T. Brooks Vaughan III, MD Department of Endocrinology UAB July 11, 2015 Brooks Vaughan, MD Associate Professor, Medicine, Pediatrics and Neurosurgery Medical Director, Neurosurgical Pituitary Disorders Clinic University of Alabama at Birmingham 1

2 Testosterone Commonly prescribed Generally safe but can have significant side effects and more questions are developing There are significant diagnostic pitfalls Taking your time before prescribing saves you grief later It is not a cure all 2

3 Testosterone Pharmaceutical companies have convinced patients and physicians that Low T is a huge problem Web sites are extremely misleading (my opinion) and imply that a variety of conditions potentially caused by low testosterone Obesity Diabetes HTN Hyperlipidemia Asthma/COPD (from manufacturer website) What is not said, is that while potentially related, there is no proven cause/effect Testosterone Low T Quizzes Extremely nonspecific Do you have diminished libido? Do you have lack of energy? Do you have a decrease in strength/endurance? Have you lost height? Have you noticed a decrease in your enjoyment of life? 3

4 Testosterone Testosterone Therapy in Men with Androgen Deficiency Syndromes: An Endocrine Society Clinical Practice Guideline, 2010 Testosterone Testosterone Therapy in Men with Androgen Deficiency Syndromes: An Endocrine Society Clinical Practice Guideline,

5 Diagnosing Hypogonadism in Men One should first obtain a total MORNING testosterone (this is critical and flagged in the UAB system). Afternoon levels can be up to 50% lower than AM levels. This should be repeated for confirmation if low (30% may be normal) Low has had various definitions. The low end of the normal range is fine. There is NO EVIDENCE to support the assertion of optimal levels If levels are borderline, or you do not suspect hypogonadism, get a total and free testosterone with an SHBG Do not do this workup while a patient is ill 5

6 Why you want to get this right If you treat someone for hypogonadism who does not have it, there symptoms will not improve They will continue to call your office and request increased doses and alternate forms of therapy You may ultimately regret being systematic on the front end Patients who feel they have hypogonadism and are not treated can become upset and leave your practice, so there is pressure Why you want to get this right This is expensive, lifelong therapy It requires lifelong monitoring It can cause infertility It can cause polycythemia It can stimulate (but likely not cause) prostate cancer It can worsen sleep apnea, which mimics many of the same symptoms 6

7 Case 38 yo male with fatigue as main complaint Mild libido loss Normal shaving habits, no gynecomastia, heavy afternoon beard, oil skin, completely normal genital exam Goes for a 4 pm testosterone panel at primary MD s office. It comes back 174 ng/dl ( ) He is started on testosterone injections Case He feels better for a month or two, but ultimately his symptoms return The shots seem to make no difference He has repeat testosterone levels that are normal (575 ng/dl) He begins to question his diagnosis and requests referral When seen by me, he has been off testosterone for 4 weeks 7

8 Case An AM testosterone is repeated, with a free testosterone and SHBG AM testosterone is 190 ng/dl ( ) Free testosterone is 9 ng/dl (5 13) SHBG is low at 8 (10 57 nmol/l) This explains his low total testosterone His free levels are completely normal, consistent with his physical exam He is satisfied that he does not have hypogonadism When to worry Remember that young men shouldn t have this problem You owe them an explanation of why it is happening Fertility implications You don t want to miss a serious underlying case If FSH/LH elevated, it is primary gonadal failure Klinefelter s (small testes) Testicular trauma Fertility options may be limited but should be evaluated 8

9 When to worry If LH/FSH are normal or low, it is secondary hypogonadism Kallmann syndrome (anosmia) Chronic opiate use Glucocorticoids Prolactinomas Hemochromatosis Other pituitary function may need assessment MRI should be considered Fertility options are better When to Worry Extremely low levels are unusual If values are significantly below normal in the AM, do a full evaluation or refer if uncomfortable Many pituitary tumors present with severe central hypogonadism The obvious athlete/bodybuilder with low testosterone and suppressed LH/FSH (likely anabolic abuse) 9

10 Treatment Shots (200 mg every two weeks or 100 mg weekly) Monthly is too infrequent Gels and patches No medical superiority to any one method Gels/patches more physiologic (steady levels) Adherence to them can be poor Issues with exposure to others JAMA Nov 6;310(17):

11 JAMA Nov 6;310(17): JAMA Nov 6;310(17):

12 JAMA Nov 6;310(17): Table 1. Rates of myocardial infarction per 1,000 persons per year (PY) in men under age 65 years and those age 65 years and older, in pre and post prescription intervals for an initial prescription for testosterone therapy rate ratios (RR) and 95% confidence intervals (CI). Finkle WD, Greenland S, Ridgeway GK, Adams JL, et al. (2014) Increased Risk of Non Fatal Myocardial Infarction Following Testosterone Therapy Prescription in Men. PLoS ONE 9(1): e doi: /journal.pone

13 Some Suggest Safety or Even a Protective Effect Baillargeon et al, Risk of MI in Older Men Receiveing Testosterone Therapy, Annals of Pharmacotherapy, 2014 FDA adding general warning to testosterone products about potential for venous blood clots [06/19/2014] The U.S. Food and Drug Administration (FDA) is requiring manufacturers to include a general warning in the drug labeling of all approved testosterone products about the risk of blood clots in the veins. Blood clots in the veins, also known as venous thromboembolism (VTE), include deep vein thrombosis (DVT) and pulmonary embolism (PE). The risk of venous blood clots is already included in the labeling of testosterone products as a possible consequence of polycythemia, an abnormal increase in the number of red blood cells that sometimes occurs with testosterone treatment. Because there have been postmarket reports of venous blood clots unrelated to polycythemia, FDA is requiring a change to drug labeling of all testosterone products to provide a more general warning regarding venous blood clots and to ensure this risk is described consistently in the labeling of all approved testosterone products. Because these clots occur in the veins, this new warning is not related to FDA s ongoing evaluation of the possible risk of stroke, heart attack, and death in patients taking testosterone products. We are currently evaluating the potential risk of these cardiovascular events, which are related to blood clots in the arteries and are described in the Drug Safety Communication posted on January 31,

14 FDA evaluating risk of stroke, heart attack and death with FDA-approved testosterone products Safety Announcement [ ] The U.S. Food and Drug Administration (FDA) is investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products. We have been monitoring this risk and decided to reassess this safety issue based on the recent publication of two separate studies that each suggested an increased risk of cardiovascular events among groups of men prescribed testosterone therapy. We are providing this alert while we continue to evaluate the information from these studies and other available data, and will communicate our final conclusions and recommendations when the evaluation is complete. At this time, FDA has not concluded that FDA-approved testosterone treatment increases the risk of stroke, heart attack, or death. Patients should not stop taking prescribed testosterone products without first discussing any questions or concerns with their health care professionals. Health care professionals should consider whether the benefits of FDAapproved testosterone treatment is likely to exceed the potential risks of treatment. The prescribing information in the drug labels of FDA-approved testosterone products should be followed. Testosterone is a hormone essential to the development of male growth and masculine characteristics. Testosterone products are FDA-approved only for use in men who lack or have low testosterone levels in conjunction with an associated medical condition. Examples of these conditions include failure of the testicles to produce testosterone, because of reasons such as genetic problems or chemotherapy. Other examples include problems with brain structures, called the hypothalamus and pituitary that control the production of testosterone by the testicles. 14

15 Very few (No?) reasons to write this drug outside of endocrinology Almost always seen in the setting of a pituitary/hypothalamic disorder Almost always seen in conjunction with other pituitary deficiencies Isolated, idiopathic growth hormone deficiency is a controversial entity in adults (may not exist) There are specific recommendations AGAINST screening for growth hormone deficiency in the general population Evaluation and Treatment of Adult Growth Hormone Deficiency: An Endocrine Society Clinical Practice Guideline,

16 FDA Approved Indications Growth hormone deficiency in children Turner syndrome (in children not deficient) Chronic renal insufficiency (in children not deficient) Small for gestational age (not deficient) Idiopathic short stature (not deficient) Adults with GHD with pituitary, hypothalamic lesions, injuries or irradiation (deficient) AIDS wasting syndrome (not deficient limited data) Short bowel syndrome (not deficient limited data) Kids with Growth Hormone Deficiency Should be reassessed as adults The IGF 1 off of growth hormone is felt to be a sufficient screening test The majority of kids with isolated GHD will not need GH as adults 16

17 Head Trauma An emerging area of concern Growth hormone deficiency (and other hormonal deficiencies) likely under diagnosed 17

18 Growth Hormone: Benefits in the Deficient Bone density (limited fracture data) Lipids (not seen universally) Well being Cardiovascular function Muscle mass/strength Growth Hormone Risks Contraindicated in a known cancer Edema, arthralgias In kids, SCFE, pseudotumor cerebri Carpal tunnel (if overdosed) Worsening of glucose intolerance or diabetes There is now a test for synthetic GH (wasn t for years) Postmenopausal Hormone Therapy. An Endocrine Society Scientific Statement,

19 Bioidentical Hormones Generally used in the context of estrogen and progesterone replacement The term has a basis in fact there are some hormonal preparations that are more identical to human hormonal preparations than others Some suggest that this greater affinity to human hormonal structures leads to greater clinical benefit This is anecdotal, but a strongly held believe by some Postmenopausal Hormone Therapy. An Endocrine Society Scientific Statement,

20 Postmenopausal Hormone Therapy. An Endocrine Society Scientific Statement, Clinician s dilemma Regardless of the makeup of the hormones, issues surrounding female hormone replacement in postmenopausal women remain unresolved There is no evidence that bioidentical hormones have a different risk profile in this regard Many are not FDA regulated (c0mpounded) Lab testing is not well standardized and there are no published guidelines in terms of what levels to aim for, and what levels are safe 20

21 Bioidentical Hormones Specific Issues No data to support: That compounded preparations are in any way superior to FDA approved formulations Any less risk with these preparations Any validity to using salivary tests to dose Any claims of a lower risk of breast or uterine cancer Postmenopausal Hormone Therapy. An Endocrine Society Scientific Statement, Postmenopausal Hormone Replacement Therapy: Good Evidence Relieves menopausal symptoms (E) Reduces symptoms of overactive bladder (E) Reduces recurrent UTIs (E) Positive effects on bone mass and fracture rates (E or E+P) Decreases colon cancer risk (E+P) Increases mammographic density (E and E+P) Improves libido (T) Increases risk of thrombosis (E and E+P) Increases risk of uterine cancer (E alone with intact uterus) Increases risk of gallbladder disease (E and E+P) No effect on cognition (any combo) Postmenopausal Hormone Therapy. An Endocrine Society Scientific Statement,

22 Postmenopausal Hormone Therapy. An Endocrine Society Scientific Statement,

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