Thyroid hormone treatment among pregnant women with subclinical hypothyroidism: US national assessment

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Abstract

Objective To estimate the effectiveness and safety of thyroid hormone treatment among pregnant women with subclinical hypothyroidism.

Design Retrospective cohort study.

Setting Large US administrative database between 1 January 2010 and 31 December 2014.

Participants 5405 pregnant women with subclinical hypothyroidism, defined as untreated thyroid stimulating hormone (TSH) concentration 2.5-10 mIU/L.

Exposure Thyroid hormone therapy.

Main outcome measure Pregnancy loss and other pre-specified maternal and fetal pregnancy related adverse outcomes.

Results Among 5405 pregnant women with subclinical hypothyroidism, 843 with a mean pre-treatment TSH concentration of 4.8 (SD 1.7) mIU/L were treated with thyroid hormone and 4562 with a mean baseline TSH concentration of 3.3 (SD 0.9) mIU/L were not treated (P<0.01). Pregnancy loss was significantly less common among treated women (n=89; 10.6%) than among untreated women (n=614; 13.5%) (P<0.01). Compared with the untreated group, treated women had lower adjusted odds of pregnancy loss (odds ratio 0.62, 95% confidence interval 0.48 to 0.82) but higher odds of preterm delivery (1.60, 1.14 to 2.24), gestational diabetes (1.37, 1.05 to 1.79), and pre-eclampsia (1.61, 1.10 to 2.37); other pregnancy related adverse outcomes were similar between the two groups. The adjusted odds of pregnancy loss were lower in treated women than in untreated women if their pre-treatment TSH concentration was 4.1-10 mIU/L (odds ratio 0.45, 0.30 to 0.65) but not if it was 2.5-4.0 mIU/L (0.91, 0.65 to 1.23) (P<0.01).

Conclusion Thyroid hormone treatment was associated with decreased risk of pregnancy loss among women with subclinical hypothyroidism, especially those with pre-treatment TSH concentrations of 4.1-10 mIU/L. However, the increased risk of other pregnancy related adverse outcomes calls for additional studies evaluating the safety of thyroid hormone treatment in this patient population.

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Most cited references 19

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Management of thyroid dysfunction during pregnancy and postpartum: an Endocrine Society clinical practice guideline.

Leslie De Groot, Marcos Abalovich, Erik Alexander … (2012)

The aim was to update the guidelines for the management of thyroid dysfunction during pregnancy and postpartum published previously in 2007. A summary of changes between the 2007 and 2012 version is identified in the Supplemental Data (published on The Endocrine Society's Journals Online web site at http://jcem.endojournals.org). This evidence-based guideline was developed according to the U.S. Preventive Service Task Force, grading items level A, B, C, D, or I, on the basis of the strength of evidence and magnitude of net benefit (benefits minus harms) as well as the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) system to describe both the strength of recommendations and the quality of evidence. The guideline was developed through a series of e-mails, conference calls, and one face-to-face meeting. An initial draft was prepared by the Task Force, with the help of a medical writer, and reviewed and commented on by members of The Endocrine Society, Asia and Oceania Thyroid Association, and the Latin American Thyroid Society. A second draft was reviewed and approved by The Endocrine Society Council. At each stage of review, the Task Force received written comments and incorporated substantive changes. Practice guidelines are presented for diagnosis and treatment of patients with thyroid-related medical issues just before and during pregnancy and in the postpartum interval. These include evidence-based approaches to assessing the cause of the condition, treating it, and managing hypothyroidism, hyperthyroidism, gestational hyperthyroidism, thyroid autoimmunity, thyroid tumors, iodine nutrition, postpartum thyroiditis, and screening for thyroid disease. Indications and side effects of therapeutic agents used in treatment are also presented.

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2014 European Thyroid Association Guidelines for the Management of Subclinical Hypothyroidism in Pregnancy and in Children

John Lazarus, Rosalind S. Brown, Chantal Daumerie … (2014)

This guideline has been produced as the official statement of the European Thyroid Association guideline committee. Subclinical hypothyroidism (SCH) in pregnancy is defined as a thyroid-stimulating hormone (TSH) level above the pregnancy-related reference range with a normal serum thyroxine concentration. Isolated hypothyroxinaemia (defined as a thyroxine level below the 2.5th centile of the pregnancy-related reference range with a normal TSH level) is also recognized in pregnancy. In the majority of SCH the cause is autoimmune thyroiditis but may also be due to iodine deficiency. The cause of isolated hypothyroxinaemia is usually not apparent, but iodine deficiency may be a factor. SCH and isolated hypothyroxinaemia are both associated with adverse obstetric outcomes. Levothyroxine therapy may ameliorate some of these with SCH but not in isolated hypothyroxinaemia. SCH and isolated hypothyroxinaemia are both associated with neuro-intellectual impairment of the child, but there is no evidence that maternal levothyroxine therapy improves this outcome. Targeted antenatal screening for thyroid function will miss a substantial percentage of women with thyroid dysfunction. In children SCH (serum TSH concentration >5.5-10 mU/l) normalizes in >70% and persists in the majority of the remaining patients over the subsequent 5 years, but rarely worsens. There is a lack of studies examining the impact of SCH on the neuropsychological development of children under the age of 3 years. In older children, the evidence for an association between SCH and impaired neuropsychological development is inconsistent. Good quality studies examining the effect of treatment of SCH in children are lacking.

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Comparison of drug adherence rates among patients with seven different medical conditions.

Iracema S Andrade, Hassan Fouayzi, Jim K H Chan … (2008)

To compare drug adherence rates among patients with gout, hypercholesterolemia, hypertension, hypothyroidism, osteoporosis, seizure disorders, and type 2 diabetes mellitus by using a standardized approach. Longitudinal study. Health care claims data from 2001-2004. A total of 706,032 adults aged 18 years or older with at least one of the seven medical conditions and with incident use of drug therapy for that condition. Drug adherence was measured as the sum of the days' supply of drug therapy over the first year observed. Covariates were age, sex, geographic residence, type of health plan, and a comorbidity score calculated by using the Hierarchical Condition Categories risk adjuster. Bivariate statistics and stratification analyses were used to assess unadjusted means and frequency distributions. Sample sizes ranged from 4984 subjects for seizure disorders to 457,395 for hypertension. During the first year of drug therapy, 72.3% of individuals with hypertension achieved adherence rates of 80% or better compared with 68.4%, 65.4%, 60.8%, 54.6%, 51.2%, or 36.8% for those with hypothyroidism, type 2 diabetes, seizure disorders, hypercholesterolemia, osteoporosis, or gout, respectively. Age younger than 60 years was associated with lower adherence across all diseases except seizure disorders. Comorbidity burden and adherence varied by disease. As comorbidity increased, adherence among subjects with osteoporosis decreased, whereas adherence among those with hypertension, hypercholesterolemia, or gout increased. Add-on drug therapies and previous experience with taking drugs for the condition increased adherence among subjects with hypertension, type 2 diabetes, hypothyroidism, or seizure disorders but not the other conditions. This uniform comparison of drug adherence revealed modest variation across six of seven diseases, with the outlier condition being gout.

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Author and article information

Contributors

Spyridoula Maraka: Role: assistant professor of medicine

Raphael Mwangi: Role: statistical programmer analyst

Rozalina G McCoy: Role: assistant professor of medicine

Xiaoxi Yao: Role: research associate

Lindsey R Sangaralingham: Role: assistant professor of health services research

Naykky M Singh Ospina: Role: assistant professor of medicine

Derek T O’Keeffe: Role: assistant professor of medicine

Ana E Espinosa De Ycaza: Role: instructor in medicine

Rene Rodriguez-Gutierrez: Role: postdoctoral researcher

Charles C Coddington III: Role: professor of medicine

Marius N Stan: Role: assistant professor of medicine

Juan P Brito: Role: assistant professor of medicine

Victor M Montori: Role: professor of medicine

Journal

Journal ID (nlm-ta): BMJ

Journal ID (iso-abbrev): BMJ

Journal ID (publisher-id): bmj

Title: The BMJ

Publisher: BMJ Publishing Group Ltd.

ISSN (Print): 0959-8138

ISSN (Electronic): 1756-1833

Publication date Collection: 2017

Publication date (Electronic): 25 January 2017

Volume: 356

Electronic Location Identifier: i6865

Affiliations

[1 ]Division of Endocrinology and Metabolism, Center for Osteoporosis and Metabolic Bone Diseases, University of Arkansas for Medical Sciences and the Central Arkansas Veterans Health Care System, Little Rock, AR 72205, USA

[2 ]Knowledge and Evaluation Research Unit in Endocrinology (KER_Endo), Mayo Clinic, Rochester, MN 55905, USA

[3 ]Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN 55905, USA

[4 ]Division of Primary Care Internal Medicine, Department of Medicine, Mayo Clinic, Rochester, MN 55905, USA

[5 ]Division of Health Care Policy and Research, Department of Health Services Research, Mayo Clinic, Rochester, MN 55905, USA

[6 ]Optum Labs, Cambridge, MA 02142, USA

[7 ]Division of Endocrinology, Department of Medicine, University of Florida, Gainesville, FL 32610, USA

[8 ]Division of Endocrinology, Department of Medicine, National University of Ireland, Galway, Ireland

[9 ]Division of Endocrinology, Diabetes, Metabolism, and Nutrition, Mayo Clinic, Rochester, MN 55905, USA

[10 ]Division of Endocrinology, Department of Internal Medicine, University Hospital “Dr. Jose E. Gonzalez,” Autonomous University of Nuevo Leon, Monterrey, 64460, Mexico

[11 ]Department of Obstetrics and Gynecology, Mayo Clinic, Rochester, MN 55905, USA

Author notes

Correspondence to: R G McCoy mccoy.rozalina@ 123456mayo.edu

Article

Publisher ID: mars034233

DOI: 10.1136/bmj.i6865

PMC ID: 5266622

PubMed ID: 28122781

SO-VID: 0df64565-c583-46fa-97fa-643bb179be69

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This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 3.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/3.0/.

Thyroid hormone treatment among pregnant women with subclinical hypothyroidism: US national assessment

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Bioscientifica Open Endocrinology

Most cited references 19

Management of thyroid dysfunction during pregnancy and postpartum: an Endocrine Society clinical practice guideline.

2014 European Thyroid Association Guidelines for the Management of Subclinical Hypothyroidism in Pregnancy and in Children

Comparison of drug adherence rates among patients with seven different medical conditions.

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