Thyroid Hot Topics. AACE Atlanta, GA January 26-27, 2018

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1 Thyroid Hot Topics AACE Atlanta, GA January 26-27, 2018 Michael T. McDermott MD Director, Endocrinology and Diabetes Practice University of Colorado Hospital

2 Disclosure Michael McDermott MD Financial Relationships Consultant: Novo Nordisk Any unlabeled/unapproved uses of drugs or products referenced will be disclosed

3 Thyroid Hot Topics What TSH goal is best for your patient with hypothyroidism? What TSH goal is best for your elderly hypothyroid patient? Should mild hypothyroidism be treated in the elderly patient? What thyroid hormone replacement is best for your patient? What about your patient with persistent symptoms on therapy?

4 Case: Lance Boyle, ED Physician 45 y.o. man managed by you for post-ablative hypothyroidism. He is a competitive cyclist and says he performs best when his TSH is in the lower end of the reference range. He requests a dose change. PMH: Hypothyroidism Meds: Levothyroxine 125 mcg QD PE: BP 118/68 P 64 Ht 6 1 Wt 175 lb. General Exam: normal Thyroid: small Lab: TSH 2.8 mu/l (nl: ) Free T4 1.3 ng/dl (nl: ) Would he benefit from an increase in his LT4 dose?

5 Thyroid Hot Topics What TSH Goal is Best for Your Patient With Hypothyroidism?

6 TSH Distribution in Normal Population Optimal TSH Goal: mu/l? Not Validated by Evidence

7 Hypothyroidism Treatment Guidelines ATA/AACE 2012 and ATA 2014 Optimal TSH Goal Evidence does not support targeting specific TSH values within the normal reference range This includes the following types of patients: Obese, Depressed, Athyreotic Garber J, Endocr Pract 2012; 18: Jonklass J, Thyroid 2014; 24:

8 TSH Variation Within Normal Range Effect on Symptoms in Hypothyroid Subjects 56 Patients: Hypothyroidism on LT4 > 100 mcg/d RCT Crossover: TSH Target Low, Middle or High Normal TSH Levels Achieved (mean) Low Nl: 0.3 mu/l Middle Nl: 1.0 mu/l High Nl: 2.8 mu/l No Difference Low vs Middle vs High Nl Hypothyroid Symptoms Well Being Quality of Life Cognitive Function Treatment Preference Walsh J, J Clin Endocrinol Metab 2006; 91:

9 Levothyroxine Therapy Goal What Serum TSH Level is Best? 133 Patients with Thyroid Cancer Before/After Thyroidectomy Hormones TSH Free T4 Free T3 Thyroid Hormone Tissue Markers Sex Hormone Binding Globulin Bone Alkaline Phosphatase Tartrate Resistant Acid Phosphatase Lipoproteins Compared TSH < 0.03 mu/l TSH mu/l TSH mu/l Thyroid Hormone Tissue Markers Were Closest To Pre-Operative Values With TSH Levels: mu/l Ito M. Thyroid 2017; 27:

10 Case: Justin Case, Retired Insurance Salesman 80 y.o. man presents for his annual thyroid follow-up. He feels well and has no current complaints. PMH: Hypothyroidism, CAD, HTN, DJD Meds: Levothyroxine 112 mcg QD, Heart and BP meds PE: BP 142/72 P 70 Ht 5 11 Wt 165 lb. General Exam: normal Thyroid: normal Lab: TSH 0.8 mu/l (nl: ) Free T4 1.3 ng/dl (nl: ) Do you recommend a levothyroxine dose adjustment?

11 Thyroid Hot Topics What TSH Goal is Best for Your Elderly Hypothyroid Patient?

12 TSH Distribution Changes with Age Surks MI, J Clin Endocrinol Metab 2007; 92:

13 Higher TSH Levels Associated with Longevity Healthy Centenarians 232 Ashkenazi Jewish Subjects > 90 Years: Mean Age Ashkenazi Controls: Mean Age 72 Atzmon G, J Clin Endocrinol Metab 2009; 94:1251-4

14 Subclinical Hyperthyroidism Osteoporosis Risk 15 Studies (15 Women, 5 Men) 9 Cross-sectional 3 Longitudinal 3 Retrospective Cohort Suppressed TSH (any cause): h Fracture Risk LT4 Therapy (well managed): No Effect Murphy E. Clin Endocrinol 2004; 61:285

15 Subclinical Hyperthyroidism Atrial Fibrillation and Mortality Risk Pooled-Analysis: 52,674 Subjects from 10 Cohorts 2,188 Subjects with Endogenous SC Hyperthyroidism Condition HR (95% CI) Total Mortality 1.24 ( ) CHD Mortality 1.29 ( ) Atrial Fibrillation 1.68 ( ) Collet TH. Arch Intern Med 2012; 172:

16 Thyroid Hormone Overtreatment is Common Author Setting Low TSH (%) Ross 1990 Endocrine Clinic 14% Canaris 2000 State Health Fair 21% Ross D, J Clin Endocrinol Metab 1990; 71:764-9 Canaris G, Arch Intern Med 2000; 160:526-34

17 Hypothyroidism Treatment Guidelines ATA/AACE 2012 and ATA 2014 TSH Goals in the Elderly Based on the current evidence, it is reasonable to raise the target serum TSH to 4 6 mu/l in persons greater than age years Garber J, Endocr Pract 2012; 18: Jonklass J, Thyroid 2014; 24:

18 Thyroid Hot Topics Should mild hypothyroidism be treated in the Elderly Patient?

19 Case: Rose Bush, Garden Society President 76 y.o. woman reports chronic worsening fatigue, dry skin and recent hair loss during her annual evaluation with her PCP. PMH: DM2, HTN Meds: Metformin, Lisinopril, Atorvastatin PE: BP 135/72 P 74 Ht 5 7 Wt 152 lb. General Exam: normal Thyroid: normal Lab: TSH 6.6 mu/l (nl: ) Free T4 1.1 ng/dl (nl: ) 6 weeks later Lab: TSH 6.8 mu/l Free T4 1.0 ng/dl TPO antibodies positive How would you manage her thyroid condition?

20 Subclinical Hypothyroidism Cardiovascular Risk Age > Persistent SCH Subjects (Age > 65): 10 Year F/U, Not on LT4 CHD SCH No Effect Age > 65 Heart Failure CVD Death Cardiovascular Health Study Hyland K, J Clin Endocrinol Metab 2013; 98:533-40

21 Subclinical Hypothyroidism All Cause Mortality Age > Subjects (Age > 65): 12 year Follow-up, Not on LT4 CHD CV Mortality All Cause Mortality Age > 65: No h Overall Mortality or CV Death Cardiovascular Health Study, Cappola A, JAMA 2006; 295:

22 Subclinical Hypothyroidism All Cause Mortality Oldest Old 843 Subjects (Mean Age 85): Cardiovascular Health All Stars Study, Not on LT4 Subclinical Hypothyroid Vs Normal TPO Pos Vs TPO Neg Cumulative Mortality SCH No Effect Waring A, J Clin Endocrinol Metab 2012; 97:

23 Subclinical Hypothyroidism Treatment Effect of LT4 Rx: Ischemic Heart Disease UK General Practice Database: Patients with TSH 5-10 mu/l IHD Events Age N = 3,093 Age > 70 N = 1,642 HR 0.61 ( ) P =.02 Rx Benefit Patients < 70 HR 0.99 ( ) P =.56 No Rx Benefit Patients > 70 Razvi S, Arch Intern Med 2012;172:811-7

24 Subclinical Hypothyroidism Guidelines ATA 2012/2014 and ETA 2013 ATA 2012/2014 TSH < 10 mu/l Consider Rx based on Individual Factors TSH > 10 mu/l Consider Rx because of CVD and CHF Risk ETA 2013 Age < Years TSH < 10 mu/l Consider Rx based on Symptoms TSH > 10 mu/l Treatment is Recommended Age > 70 Years TSH < 10 mu/l Follow Carefully without Treatment TSH > 10 mu/l Consider Rx based on Symptoms Garber J, Endocr Pract 2012; 18: Jonklass J, Thyroid 2014; 24: Pearce SH, Eur Thyroid J 2013; 2: Peeters R, N Engl J Med 2017; 376:

25 Subclinical Hypothyroidism Treatment in Elderly Patients: TRUST Study Subclinical Hypothyroidism: 737 Subjects > Age 65 TSH: mu/l Free T4: in Reference Range RCT: LT4 Rx (N=368) vs Placebo (N=369) x 1 Year Primary Outcomes Hypothyroid Symptoms Score Tiredness Score (Thyroid Related QOL Questionnaire) Stott DJ. N Engl J Med 2017; 376:

26 Subclinical Hypothyroidism Treatment in Elderly Patients: TRUST Study Stott DJ. N Engl J Med 2017; 376:

27 Subclinical Hypothyroidism Treatment in Elderly Patients: TRUST Study Primary Outcome (1 Year) LT4 Placebo P Hypothyroid Symptoms Score Tiredness Score Secondary Outcomes Blood Pressure Body Mass Index Waist Circumference Hyperthyroid Symptoms P NS NS NS NS Stott DJ. N Engl J Med 2017; 376:

28 Case: Doug Graves, Cemetery Worker 39 y.o. man reports chronic fatigue and depression since his thyroid was removed 5 years ago for thyroid cancer. He requests to be changed to a natural thyroid preparation. PMH: PTC, Hypothyroidism Meds: Levothyroxine 137 mcg QD PE: BP 122/60 P 70 Ht 5 10 Wt 182 lb. General Exam: normal Thyroid: absent Lab: TSH 0.3 mu/l (nl: ) Free T4 1.6 ng/dl (nl: ) Thyroglobulin < 0.1 ng/ml (Tg antibodies negative) Would he benefit from a change to natural thyroid pills?

29 Hypothyroidism Guidelines One Size Does Not Fit All What Thyroid Hormone Replacement is Best for Your Patient?

30 I Thyroxine Structure I NH2 HO O CH2 C C OH I I H O Levothyroxine Sodium I I NH2 HO O CH2 C Na + C O - I I H O

31 Hypothyroidism Guidelines ATA 2014 Levothyroxine Recommended as the Preparation of Choice for the Treatment of Hypothyroidism Efficacy in resolving hypothyroid symptoms Long-term experience of its benefits Favorable side effect profile Good intestinal absorption Ease of administration Long serum half-life Low cost Jonklass J, Thyroid 2014; 24:

32 LT4 / LT3 Combination Therapy Subjects: 697 Gender: 84%W Age: Dx: Hypothyroidism Design: RCT Double Blind (52 Weeks) Dosing: (Usual LT4 50 ug) + LT4 50 ug vs (Usual LT4 50 ug) + LT3 10 ug 552 Subjects Genotyped D2: Thr92Ala Homozygotes = 16% Thr92Ala: D2 instability loop related to ubiquitination General Health Questionnaire: Thr92Ala Homozygotes Baseline: Worse GHQ (p = 0.03) General Health Questionnaire: Thr92Ala Homozygotes LT4/LT3 c/w LT4 Rx: Improved GHQ (p = 0.03) Panicker V, J Clin Endocrinol Metab 2009; 94:1623-9

33

34 Hypothyroidism Treatment Guidelines ATA 2014 LT4/LT3 Combination Therapy No consistently strong evidence of superiority of LT4/LT3 combination therapy over LT4 alone. Recommend against routine use of LT4/LT3 combination therapy. Jonklass J, Thyroid 2014; 24:

35

36 Hypothyroidism Treatment Guidelines ATA 2014 Desiccated Thyroid Extract Therapy Levothyroxine preferred as routine care for primary hypothyroidism. Potential Safety Concerns of DTE: 1. Supraphysiologic serum T3 levels (transient). 2. Paucity of long-term safety outcome data. Jonklass J, Thyroid 2014; 24:

37 Levothyroxine Therapy Altered Circulating T3 / T4 Ratio NHANES Survey LT4 Patients Controls (469) (469) P-Value TSH (mu/l) Free T3 (pg/ml) < Free T4 (ng/ml) < FT3/FT4 Ratio < Peterson S, McAninch E, Bianco A. J Clin Endocrinol Metab 2016; 101:

38 Levothyroxine Therapy Altered Circulating T3 / T4 Ratio LT4 Patients Controls (469) (469) P-Value BMI < Kcal Consumption Physical Activity 41% 32% < 0.01 Anti-Depressant Use 22% 15% < 0.01 Peterson S, McAninch E, Bianco A. J Clin Endocrinol Metab 2016; 101:

39 Desiccated Thyroid Extract Methods: ATA, AACE, Endocrine Society members developed survey instrument and ed it to frequent TH prescribers Number Issue Reported Adverse Events 174 AE with TSH Changes 91 (52%) Symptoms with TSH Change 62 (68%) Symptoms c/w Thyrotoxicosis 40 (65%) Cardiac Rhythm Disorders 2 No Levothyroxine Alone Comparator Group Shresta RT, Haugen B. Endocr Pract 2017; 23(5):566-75

40 Case: Page Turner, Librarian 43 y.o. woman self-referred for management of hypothyroidism that was diagnosed 8 years ago. She reports chronic fatigue, weight gain, constipation, cold intolerance and dry skin. Previous thyroid tests have been normal. But she has done online research and feels that it must be a thyroid problem. PMH: Hypothyroidism, Gluten Intolerance Meds: Vitamins, Supplements PE: BP 125/82 P 80 Ht 5 8 Wt 149 lb. General Exam: normal Lab: TSH 1.2 mu/l (nl: ) Free T4 1.4 ng/dl (nl: ) Thyroid: firm, granular What measures do you recommend for her current symptoms?

41 Hypothyroidism Guidelines One Size Does Not Fit All What About Your Patient with Persistent Symptoms on Therapy?

42 Persistent Symptoms on LT4 Therapy Community Based Questionnaire Study: 397 Hypothyroid Patients with Normal TSH on LT4 397 Control Subjects (matched for gender and age) Abnormal Survey Score 50% 25% P =.014 P < % 34% 35% 49% Controls Patients 0% General Health Questionnaire Thyroid Symptom Questionnaire Saravanan P, Clin Endo 2002; 57:577-85

43 Primary Hypothyroidism Different Causes are Unique Unique Features Chronic Lymphocytic Thyroiditis Thyroid Inflammation Autoimmune Diathesis Post-Ablative Hypothyroidism Parathyroid Dysfunction (?) Fear of Cancer (?) Post-Surgical Hypothyroidism Parathyroid Dysfunction (?) Vocal Cord Dysfunction (?)

44 Chronic Lymphocytic Thyroiditis Some Symptoms May Be Independent of Thyroid Hormone Levels 426 Euthyroid Women with Goiter: Thyroidectomy TPO Ab Pos TPO Ab Neg P TSH mu/l NS Symptom <.001 Score Symptoms Associated with TPO Antibodies Fatigue, Irritability, Nervousness, Dry Hair, Lower Quality of Life Ott J, Thyroid 2011; 21:161-7

45 Chronic Lymphocytic Thyroiditis Coexistence of Other Autoimmune Diseases 495 Subjects Women Men Rheumatoid Arthritis 4.7% 1.5% B12 Deficiency 4.5% 0% Addison s Disease 1.2% 3% Celiac Disease 1.2% 0% Multiple Sclerosis 0.7% 1.5% Inflammatory Bowel Disease 0.7% 1.5% Systemic Lupus Erythematosus 0.7% 0% Any Autoimmune Disease: 14.3% Boelaert K, Am J Med 2010; 183:e1-9

46 ATA Hypothyroid Patient Survey 12,000 Respondents (95% Women) Etiology 25% 10% 20% 40% Hashimoto's Thyroiditis Post-Surgical Hypothyroidism Post-Ablative Hypothyroidism Don't Know Peterson SJ (submitted for publication)

47 ATA Hypothyroid Patient Survey 12,000 Respondents (95% Women) 25% 10% 60% Peterson SJ (submitted for publication)

48 ATA Hypothyroid Patient Survey 12,000 Respondents (95% Women) Satisfaction Visual Analog Scale (1-10): 5 (mean) Reason for Dissatisfaction Fatigue / Low Energy 75% Body Weight Issues 70% Memory Problems 55% Mood Problems 45% Other 35% Peterson SJ (submitted for publication)

49 ATA Hypothyroid Patient Survey Satisfaction with Doctor - VA Scale (1-10): 5-6 (mean) Doctor Knowledgeable - VA Scale (1-10): 5-6 (mean) How Often Have You Changed Doctors 1-4 Times 45% 5-10 Times 10% Peterson SJ (submitted for publication)

50 Hypothyroidism Treatment Patients with Persistent Symptoms on LT4 Therapy LT4/LT3 Combination Therapy Desiccated Thyroid Extract Therapy Some patients prefer combined LT4/LT3 or DTE Reasonable in patients with persistent symptoms if done safely (maintain TSH in reference range) Jonklass J, Thyroid 2014; 24:

51 Thank You

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