학술논문

Thyroid antibodies and levothyroxine effects in subclinical hypothyroidism: A pooled analysis of two randomized controlled trials
Document Type
article
Source
Journal of Internal Medicine. 292(6)
Subject
Biomedical and Clinical Sciences
Clinical Sciences
Clinical Trials and Supportive Activities
Clinical Research
Evaluation of treatments and therapeutic interventions
6.1 Pharmaceuticals
Good Health and Well Being
Female
Humans
Aged
Male
Thyroxine
Randomized Controlled Trials as Topic
Hypothyroidism
Hormone Replacement Therapy
autoimmune thyroid disease
levothyroxine treatment
subclinical hypothyroidism
Cardiovascular System & Hematology
Clinical sciences
Language
Abstract
BackgroundAntithyroid 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).ObjectiveTo determine whether older adults with SHypo and positive antibodies derive more clinical benefits from LT4 than those with negative antibodies.MethodsWe 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.ResultsAmong 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.ConclusionsAmong older adults with SHypo, positive antithyroid antibodies are not associated with more benefits on clinical outcomes with LT4.