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Teprotumumab (Tepezza) - Thyroid eye disease Drug Approval Package: TEPEZZA TEPEZZA " /> U.S. Department of Health and Human Services Search FDA Submit search Drug Approval Package: TEPEZZA Company: Horizon Therapeutics Ireland DAC Application Number: 761143 Approval Date: 01/21/2020 Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance. FDA Approval Letter and Labeling (PDF) (PDF) FDA Application Review Files (PDF) (PDF) (PDF) (PDF) (PDF
Thyroid hormones treatment for subclinical hypothyroidism Thyroid hormones treatment for subclinical hypothyroidism: a clinical practice guideline | The BMJ Intended for healthcare professionals Username * Password * Edition: Search form Search Search Thyroid hormones... Thyroid hormones treatment for subclinical hypothyroidism: a clinical practice guideline (Published 14 May 2019) Cite this as: BMJ 2019;365:l2006 Visual summary of recommendation or No thyroid hormones Thyroid hormones (...) Levothyroxine Interventions compared Recommendation Population Adults with subclinical hypothyroidism Does not apply to: May not apply to: Including: Women who are or trying to become pregnant Patients with no symptoms (diagnosed after screening) Patients with non-specific symptoms Patients with severe symptoms Patients with TSH above 20 mIU/L Young adults (such as <30 years) Elevated levels of thyroid stimulating hormone (TSH) Normal free T4 (thyroxine) levels We recommend against thyroid hormone therapy
Lenvatinib (thyroid carcinoma) - Benefit assessment according to §35a Social Code Book V Extract 1 Translation of Sections 2.1 to 2.6 of the dossier assessment Lenvatinib (Schilddrüsenkarzinom) – Nutzenbewertung gemäß § 35a SGB V (Version 1.0; Status: 13 May 2019). Please note: This translation is provided as a service by IQWiG to English-language readers. However, solely the German original text is absolutely authoritative and legally binding. IQWiG Reports – Commission No. A19-19 Lenvatinib (...) (thyroid carcinoma) – Benefit assessment according to §35a Social Code Book V 1 Extract of dossier assessment A19-19 Version 1.0 Lenvatinib (thyroid carcinoma) 13 May 2019 Institute for Quality and Efficiency in Health Care (IQWiG) - i - Publishing details Publisher: Institute for Quality and Efficiency in Health Care Topic: Lenvatinib (thyroid carcinoma) – Benefit assessment according to §35a Social Code Book V Commissioning agency: Federal Joint Committee Commission awarded on: 15 February 2019
Screening for thyroid dysfunction and treatment of screen-detected thyroid dysfunction in asymptomatic, community-dwelling adults: a systematic review This systematic review was conducted to inform the Canadian Task Force on Preventive Health Care recommendations on screening for thyroid dysfunction (TD). The review sought to answer key questions on the benefits and harms of screening for TD, patients' values and preferences for screening, and the benefits and harms of treating screen-detected
Does the ATA Risk Stratification Apply to Patients with Papillary Thyroid Microcarcinoma? The incidence of papillary thyroid microcarcinoma (PTMC) has increased over the past decade. The American Thyroid Association (ATA) suggests that these patients may undergo either thyroid lobectomy or active surveillance. It remains unclear whether there exists a subgroup of PTMC patients who may benefit from more aggressive treatment due to increased risk of recurrence.We retrospectively reviewed 357
Recommendation on screening adults for asymptomatic thyroid dysfunction in primary care Recommendation on screening adults for asymptomatic thyroid dysfunction in primary care | CMAJ Main menu User menu Search Search for this keyword Search for this keyword Guideline Recommendation on screening adults for asymptomatic thyroid dysfunction in primary care Richard Birtwhistle , Kate Morissette , James A. Dickinson , Donna L. Reynolds , Marc T. Avey , Francesca Reyes Domingo , Rachel Rodin (...) of Family Medicine and Community Health Sciences (Dickinson), University of Calgary, Alta.; Dalla Lana School of Public Health and Department of Family and Community Medicine (Reynolds), University of Toronto, Ont.; Department of Psychiatry (Thombs), Jewish General Hospital and McGill University, Montréal, Que. KEY POINTS The Canadian Task Force on Preventive Health Care strongly recommends against screening for thyroid dysfunction in asymptomatic nonpregnant adults. Screening for thyroid dysfunction
Association Between Pregnancy Outcomes and Radioactive Iodine Treatment After Thyroidectomy Among Women With Thyroid Cancer Current guidelines recommend that women delay pregnancy for 6 to 12 months after the receipt of radioactive iodine treatment (RAIT) following thyroidectomy for differentiated thyroid carcinoma. Although concerns exist regarding the risks associated with pregnancy after RAIT, no large-scale study, to date, has investigated the association between RAIT and pregnancy (...) outcomes.To investigate whether RAIT was associated with increases in adverse pregnancy outcomes among South Korean women who received RAIT after thyroidectomy for thyroid cancer and to evaluate the appropriate interval between RAIT and conception.This population-based cohort study used the Health Insurance Review and Assessment database of South Korea to identify a total of 111 459 women of childbearing age (20-49 years) who underwent thyroidectomy for the treatment of differentiated thyroid carcinoma
Thyroid replacement therapy, thyroid stimulating hormone concentrations, and long term health outcomes in patients with hypothyroidism: longitudinal study. To explore whether thyroid stimulating hormone (TSH) concentration in patients with a diagnosis of hypothyroidism is associated with increased all cause mortality and a higher risk of cardiovascular disease and fractures.Retrospective cohort study.The Health Improvement Network (THIN), a database of electronic patient records from UK primary
Association of Thyroid Function Test Abnormalities and Thyroid Autoimmunity With Preterm Birth: A Systematic Review and Meta-analysis. Maternal hypothyroidism and hyperthyroidism are risk factors for preterm birth. Milder thyroid function test abnormalities and thyroid autoimmunity are more prevalent, but it remains controversial if these are associated with preterm birth.To study if maternal thyroid function test abnormalities and thyroid autoimmunity are risk factors for preterm birth.Studies (...) were identified through a search of the Ovid MEDLINE, EMBASE, Web of Science, the Cochrane Central Register of Controlled Trials, and Google Scholar databases from inception to March 18, 2018, and by publishing open invitations in relevant journals. Data sets from published and unpublished prospective cohort studies with data on thyroid function tests (thyrotropin [often referred to as thyroid-stimulating hormone or TSH] and free thyroxine [FT4] concentrations) or thyroid peroxidase (TPO) antibody
Predicting recurrence of papillary thyroid cancer using the eighth edition of the AJCC/UICC staging system The AJCC/UICC classification is widely used for predicting survival in papillary thyroid cancer (PTC), but has not been evaluated as a predictor of recurrence. The hypothesis of this study was that the eighth edition of the AJCC system can be used in this novel way.All patients in the study underwent surgery for PTC at a high-volume endocrine surgery centre in France between 1985 and 2015
Thyroxine replacement for subfertile women with euthyroid autoimmune thyroid disease or subclinical hypothyroidism. Thyroid disease is the second most common endocrine disorder affecting women of reproductive age. Subclinical hypothyroidism is diagnosed by an elevated thyroid-stimulating hormone concentration with a normal concentration of free thyroxine hormone. Autoimmune thyroid disease (ATD) is diagnosed by the presence of thyroid autoantibodies, regardless of thyroid hormone levels (...) . Thyroxine may be a useful treatment for subfertile women with these two specific types of thyroid disease for improving pregnancy outcomes during assisted reproduction.To evaluate the efficacy and harms of levothyroxine replacement in subfertile women with subclinical hypothyroidism or with normal thyroid function and thyroid autoimmunity (euthyroid autoimmune thyroid disease, or euthyroid ATD) undergoing assisted reproduction.We searched the Cochrane Gynaecology and Fertility (CGF) Group specialised
A Perioperative Small Dose of Dexamethasone Enhances Postoperative Recovery by Reducing Volume and Inflammatory Contents in Wound Drainage After Thyroid Surgery: A Double-Blinded, Randomized, Prospective Study The aims of this study were to assess the effect of perioperative dexamethasone on postoperative thyroid surgery recovery using measures of wound drainage volume and C-reactive protein (CRP) levels and leukocyte counts.From January to September 2014, healthy patients, aged between 18 (...) and 65 years, had elective thyroid surgery in the tertiary hospital. Eligible patients were randomized into either group D (dexamethasone 0.1 mg/kg IV) or group S (saline IV) after anesthesia induction. At the end of surgery, a drainage tube was placed at the thyroid bed with a negative pressure ball connected outside the wound. Drainage fluids were collected after thyroid surgery. The fluid volume and the levels of C-reactive protein and leukocyte counts inside were analyzed. All patients were
Levothyroxine in Women with Thyroid Peroxidase Antibodies before Conception. Thyroid peroxidase antibodies are associated with an increased risk of miscarriage and preterm birth, even when thyroid function is normal. Small trials indicate that the use of levothyroxine could reduce the incidence of such adverse outcomes.We conducted a double-blind, placebo-controlled trial to investigate whether levothyroxine treatment would increase live-birth rates among euthyroid women who had thyroid (...) peroxidase antibodies and a history of miscarriage or infertility. A total of 19,585 women from 49 hospitals in the United Kingdom underwent testing for thyroid peroxidase antibodies and thyroid function. We randomly assigned 952 women to receive either 50 μg once daily of levothyroxine (476 women) or placebo (476 women) before conception through the end of pregnancy. The primary outcome was live birth after at least 34 weeks of gestation.The follow-up rate for the primary outcome was 98.7% (940 of 952
Repeat thyroid function tests for healthy older people are not needed. The studyRoberts L, McCahon D, Johnson O, Haque MS, Parle J, Hobbs FR. Stability of thyroid function in older adults: the Birmingham Elderly Thyroid Study. Published on 28 August 2018 Br J Gen Pract 2018;68:e718-26.This study was funded by the National Institute for Health Research School for Primary Care Research (SPCR).To read the full NIHR Signal, go to: https://discover.dc.nihr.ac.uk/content/signal-000703/repeat-thyroid
Exenatide use and incidence of pancreatic and thyroid cancer: A retrospective cohort study A retrospective cohort study, supplemented with a nested case-control study, was performed using two administrative databases from commercial health plans in the United States to compare the incidence of pancreatic and thyroid cancer among users of exenatide versus other antidiabetic drugs (OADs). Patients with type 2 diabetes who initiated exenatide or OADs between 1 June 2005 and 30 June 2015 were (...) included. Pancreatic and thyroid cancers were identified using chart-validated algorithms in the cohort study. Cases in the nested case-control study were chart-confirmed pancreatic or thyroid cancers, and controls were sampled using risk-set sampling. The time-fixed analyses comparing 33 629 exenatide initiators with 49 317 propensity-score-matched OAD initiators yielded hazard ratios of 0.76 (95% confidence interval [CI] 0.47-1.21) for pancreatic cancer and 1.46 (95% CI 0.98-2.19) for thyroid cancer
Recurrence after low-dose radioiodine ablation and recombinant human thyroid-stimulating hormone for differentiated thyroid cancer (HiLo): long-term results of an open-label, non-inferiority randomised controlled trial Two large randomised trials of patients with well-differentiated thyroid cancer reported in 2012 (HiLo and ESTIMABL1) found similar post-ablation success rates at 6-9 months between a low administered radioactive iodine (131I) dose (1·1 GBq) and the standard high dose (3·7 GBq (...) ). However, recurrence rates following radioactive iodine ablation have previously only been reported in observational studies, and recently in ESTIMABL1. We aimed to compare recurrence rates between radioactive iodine doses in HiLo.HiLo was a non-inferiority, parallel, open-label, randomised controlled factorial trial done at 29 centres in the UK. Eligible patients were aged 16-80 years with histological confirmation of differentiated thyroid cancer requiring radioactive iodine ablation (performance
Toxic thyroid adenoma Toxic thyroid adenoma - Symptoms, diagnosis and treatment | BMJ Best Practice You'll need a subscription to access all of BMJ Best Practice Search Toxic thyroid adenoma Last reviewed: February 2019 Last updated: February 2019 Summary Typically a single large thyroid nodule accompanied by clinical and biochemical hyperthyroidism. Diagnosis confirmed by thyroid scan demonstrating a hot area and suppression of extranodular thyroid tissue. Hyperthyroidism caused by toxic (...) adenomas generally does not remit. Definitive treatment, such as radioactive iodine therapy, is usually required. Complications of untreated toxic adenomas may include sequelae of hyperthyroidism such as cardiac dysfunction or bone loss, or tracheal compression by large nodules. Definition A toxic adenoma is an autonomously functioning thyroid nodule that causes hyperthyroidism. Ross DS, Burch HB, Cooper DS, et al. 2016 American Thyroid Association guidelines for diagnosis and management