Journal article
Association Between Levothyroxine Treatment and Thyroid-Related Symptoms Among Adults Aged 80 Years and Older With Subclinical Hypothyroidism.
- Mooijaart SP Department of Gerontology and Geriatrics, Leiden University Medical Center, Leiden, the Netherlands.
- Du Puy RS Department of Public Health and Primary Care, Leiden University Medical Center, Leiden, the Netherlands.
- Stott DJ Geriatric Medicine, Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.
- Kearney PM School of Public Health, University College Cork, Cork, Ireland.
- Rodondi N Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
- Westendorp RGJ Department of Public Health, University of Copenhagen, Copenhagen, Denmark.
- den Elzen WPJ Department of Clinical Chemistry and Laboratory Medicine, Leiden University Medical Center, Leiden, the Netherlands.
- Postmus I Department of Gerontology and Geriatrics, Leiden University Medical Center, Leiden, the Netherlands.
- Poortvliet RKE Department of Public Health and Primary Care, Leiden University Medical Center, Leiden, the Netherlands.
- van Heemst D Department of Gerontology and Geriatrics, Leiden University Medical Center, Leiden, the Netherlands.
- van Munster BC Department of Internal Medicine, Academic Medical Center, Amsterdam, the Netherlands.
- Peeters RP Department of Internal Medicine, Erasmus University Medical Centre, Rotterdam, the Netherlands.
- Ford I Robertson Centre for Biostatistics, University of Glasgow, Glasgow, United Kingdom.
- Kean S Robertson Centre for Biostatistics, University of Glasgow, Glasgow, United Kingdom.
- Messow CM Robertson Centre for Biostatistics, University of Glasgow, Glasgow, United Kingdom.
- Blum MR Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
- Collet TH Service of Endocrinology, Diabetes and Metabolism, Lausanne University Hospital, Lausanne, Switzerland.
- Watt T Department of Internal Medicine, Copenhagen University Hospital Herlev, Gentofte, Denmark.
- Dekkers OM Department of Endocrinology and Metabolic Disorders, Leiden University Medical Center, Leiden, the Netherlands.
- Jukema JW Department of Cardiology, Leiden University Medical Center, Leiden, the Netherlands.
- Smit JWA Radboud University Medical Center, Nijmegen, the Netherlands.
- Langhorne P Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, United Kingdom.
- Gussekloo J Department of Gerontology and Geriatrics, Leiden University Medical Center, Leiden, the Netherlands.
- 2019-10-31
Published in:
- JAMA. - 2019
English
Importance
It is unclear whether levothyroxine treatment provides clinically important benefits in adults aged 80 years and older with subclinical hypothyroidism.
Objective
To determine the association of levothyroxine treatment for subclinical hypothyroidism with thyroid-related quality of life in adults aged 80 years and older.
Design, Setting, and Participants
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.
Exposures
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).
Main Outcomes and Measures
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).
Results
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).
Conclusions and Relevance
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.
Trial Registration
ClinicalTrials.gov Identifier: NCT01660126; Netherlands Trial Register: NTR3851.
It is unclear whether levothyroxine treatment provides clinically important benefits in adults aged 80 years and older with subclinical hypothyroidism.
Objective
To determine the association of levothyroxine treatment for subclinical hypothyroidism with thyroid-related quality of life in adults aged 80 years and older.
Design, Setting, and Participants
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.
Exposures
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).
Main Outcomes and Measures
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).
Results
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).
Conclusions and Relevance
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.
Trial Registration
ClinicalTrials.gov Identifier: NCT01660126; Netherlands Trial Register: NTR3851.
- Language
-
- English
- Open access status
- bronze
- Identifiers
-
- DOI 10.1001/jama.2019.17274
- PMID 31664429
- Persistent URL
- https://sonar.ch/global/documents/132034
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