Association Between Levothyroxine Treatment and Thyroid-Related Symptoms Among Adults Aged 80 Years and Older With Subclinical Hypothyroidism.

Details

Serval ID
serval:BIB_740CBF6DCD11
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Association Between Levothyroxine Treatment and Thyroid-Related Symptoms Among Adults Aged 80 Years and Older With Subclinical Hypothyroidism.
Journal
JAMA
Author(s)
Mooijaart S.P., Du Puy R.S., Stott D.J., Kearney P.M., Rodondi N., Westendorp RGJ, den Elzen WPJ, Postmus I., Poortvliet RKE, van Heemst D., van Munster B.C., Peeters R.P., Ford I., Kean S., Messow C.M., Blum M.R., Collet T.H., Watt T., Dekkers O.M., Jukema J.W., Smit JWA, Langhorne P., Gussekloo J.
ISSN
1538-3598 (Electronic)
ISSN-L
0098-7484
Publication state
Published
Issued date
26/11/2019
Peer-reviewed
Oui
Volume
322
Number
20
Pages
1977-1986
Language
english
Notes
Publication types: Journal Article
Publication Status: ppublish
Abstract
It is unclear whether levothyroxine treatment provides clinically important benefits in adults aged 80 years and older with subclinical hypothyroidism.
To determine the association of levothyroxine treatment for subclinical hypothyroidism with thyroid-related quality of life in adults aged 80 years and older.
Prospectively planned combined analysis of data involving community-dwelling adults aged 80 years and older with subclinical hypothyroidism. Data from a randomized clinical trial were combined with a subgroup of participants aged 80 years and older from a second clinical trial. The trials were conducted between April 2013 and May 2018. Final follow-up was May 4, 2018.
Participants were randomly assigned to receive levothyroxine (n = 112; 52 participants from the first trial and 60 from the second trial) or placebo (n = 139; 53 participants from the first trial and 86 from the second trial).
Co-primary outcomes were Thyroid-Related Quality of Life Patient-Reported Outcome (ThyPRO) questionnaire scores for the domains of hypothyroid symptoms and tiredness at 1 year (range, 0-100; higher scores indicate worse quality of life; minimal clinically important difference, 9).
Of 251 participants (mean age, 85 years; 118 [47%] women), 105 were included from the first clinical trial and 146 were included from the second clinical trial. A total of 212 participants (84%) completed the study. The hypothyroid symptoms score decreased from 21.7 at baseline to 19.3 at 12 months in the levothyroxine group vs from 19.8 at baseline to 17.4 at 12 months in the placebo group (adjusted between-group difference, 1.3 [95% CI, -2.7 to 5.2]; P = .53). The tiredness score increased from 25.5 at baseline to 28.2 at 12 months in the levothyroxine group vs from 25.1 at baseline to 28.7 at 12 months in the placebo group (adjusted between-group difference, -0.1 [95% CI, -4.5 to 4.3]; P = .96). At least 1 adverse event occurred in 33 participants (29.5%) in the levothyroxine group (the most common adverse event was cerebrovascular accident, which occurred in 3 participants [2.2%]) and 40 participants (28.8%) in the placebo group (the most common adverse event was pneumonia, which occurred in 4 [3.6%] participants).
In this prospectively planned analysis of data from 2 clinical trials involving adults aged 80 years and older with subclinical hypothyroidism, treatment with levothyroxine, compared with placebo, was not significantly associated with improvement in hypothyroid symptoms or fatigue. These findings do not support routine use of levothyroxine for treatment of subclinical hypothyroidism in adults aged 80 years and older.
ClinicalTrials.gov Identifier: NCT01660126; Netherlands Trial Register: NTR3851.
Pubmed
Web of science
Open Access
Yes
Create date
23/10/2023 12:08
Last modification date
28/10/2023 7:12
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