4.7 Article

Thyroid antibodies and levothyroxine effects in subclinical hypothyroidism: A pooled analysis of two randomized controlled trials

Journal

JOURNAL OF INTERNAL MEDICINE
Volume 292, Issue 6, Pages 892-903

Publisher

WILEY
DOI: 10.1111/joim.13544

Keywords

autoimmune thyroid disease; levothyroxine treatment; subclinical hypothyroidism

Funding

  1. Swiss National Science Foundation [PZ00P3-167826, 320030-172676, 32003B_200606]
  2. European Union [278148]
  3. Swiss Heart Foundation
  4. Velux Stiftung
  5. Netherlands Organisation for Health Research and Development (ZonMw) [627001001]
  6. European Commission [666869]
  7. ZonMw programme Evidence-based Medicine in Old Age, ZonMW programme [627001001]
  8. Leenaards Foundation
  9. Vontobel Foundation
  10. Swiss Society of Endocrinology and Diabetes
  11. Swiss Multiple Sclerosis Society
  12. NHS Greater Glasgow and Clyde Health Board
  13. University of Glasgow, UK
  14. University College Cork, Ireland
  15. Leiden University Medical Center, the Netherlands
  16. University of Bern
  17. Bern University Hospital, Switzerland
  18. Swiss National Science Foundation (SNF) [320030_172676, PZ00P3_167826, 32003B_200606] Funding Source: Swiss National Science Foundation (SNF)

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Positive antithyroid antibodies are not associated with more benefits on clinical outcomes with LT4 among older adults with SHypo.
Background Antithyroid antibodies increase the likelihood of developing overt hypothyroidism, but their clinical utility remains unclear. No large randomized controlled trial (RCT) has assessed whether older adults with subclinical hypothyroidism (SHypo) caused by autoimmune thyroid disease derive more benefits from levothyroxine treatment (LT4). Objective To determine whether older adults with SHypo and positive antibodies derive more clinical benefits from LT4 than those with negative antibodies. Methods We pooled individual participant data from two RCTs, Thyroid Hormone Replacement for Untreated Older Adults with Subclinical Hypothyroidism and IEMO 80+. Participants with persistent SHypo were randomly assigned to receive LT4 or placebo. We compared the effects of LT4 versus placebo in participants with and without anti-thyroid peroxidase (TPO) at baseline. The two primary outcomes were 1-year change in Hypothyroid Symptoms and Tiredness scores on the Thyroid-Related Quality-of-Life Patient-Reported Outcome Questionnaire. Results Among 660 participants (54% women) >= 65 years, 188 (28.5%) had positive anti-TPO. LT4 versus placebo on Hypothyroid Symptoms lead to an adjusted between-group difference of -2.07 (95% confidence interval: -6.04 to 1.90) for positive antibodies versus 0.89 (-1.76 to 3.54) for negative antibodies (p for interaction = 0.31). Similarly, there was no treatment effect modification by baseline antibody status for Tiredness scores-adjusted between-group difference 1.75 (-3.60 to 7.09) for positive antibodies versus 1.14 (-1.90 to 4.19) for negative antibodies (p for interaction = 0.98). Positive anti-TPO were not associated with better quality of life, improvement in handgrip strength, or fewer cardiovascular outcomes with levothyroxine treatment. Conclusions Among older adults with SHypo, positive antithyroid antibodies are not associated with more benefits on clinical outcomes with LT4.

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