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Thyroid hormone therapy for older adults with subclinical hypothyroidism
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Published Version
Date
2017-04-03
Authors
Stott, David J.
Rodondi, Nicolas
Kearney, Patricia M.
Ford, Ian
Westendorp, Rudi G. J.
Mooijaart, Simon P.
Sattar, Naveed
Aubert, Carole E.
Aujesky, Drahomir
Bauer, Douglas C.
Journal Title
Journal ISSN
Volume Title
Publisher
Massachusetts Medical Society
Published Version
Abstract
BACKGROUND: The use of levothyroxine to treat subclinical hypothyroidism is controversial. We aimed to determine whether levothyroxine provided clinical benefits in older persons with this condition. Full Text of Background... METHODS: We conducted a double-blind, randomized, placebo-controlled, parallel-group trial involving 737 adults who were at least 65 years of age and who had persisting subclinical hypothyroidism (thyrotropin level, 4.60 to 19.99 mIU per liter; free thyroxine level within the reference range). A total of 368 patients were assigned to receive levothyroxine (at a starting dose of 50 μg daily, or 25 μg if the body weight was <50 kg or the patient had coronary heart disease), with dose adjustment according to the thyrotropin level; 369 patients were assigned to receive placebo with mock dose adjustment. The two primary outcomes were the change in the Hypothyroid Symptoms score and Tiredness score on a thyroid-related quality-of-life questionnaire at 1 year (range of each scale is 0 to 100, with higher scores indicating more symptoms or tiredness, respectively; minimum clinically important difference, 9 points). Full Text of Methods... RESULTS: The mean age of the patients was 74.4 years, and 396 patients (53.7%) were women. The mean (±SD) thyrotropin level was 6.40±2.01 mIU per liter at baseline; at 1 year, this level had decreased to 5.48 mIU per liter in the placebo group, as compared with 3.63 mIU per liter in the levothyroxine group (P<0.001), at a median dose of 50 μg. We found no differences in the mean change at 1 year in the Hypothyroid Symptoms score (0.2±15.3 in the placebo group and 0.2±14.4 in the levothyroxine group; between-group difference, 0.0; 95% confidence interval [CI], −2.0 to 2.1) or the Tiredness score (3.2±17.7 and 3.8±18.4, respectively; between-group difference, 0.4; 95% CI, −2.1 to 2.9). No beneficial effects of levothyroxine were seen on secondary-outcome measures. There was no significant excess of serious adverse events prespecified as being of special interest. Full Text of Results... CONCLUSIONS: Levothyroxine provided no apparent benefits in older persons with subclinical hypothyroidism.
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Keywords
Subclinical hypothyroidism , Levothyroxine , Clinical trial
Citation
Stott, D. J. et al. (2017) 'Thyroid Hormone Therapy for Older Adults with Subclinical Hypothyroidism', New England Journal of Medicine, 376(26), pp. 2534-2544. doi:10.1056/NEJMoa1603825
Copyright
From New England Journal of Medicine, Stott et al, Thyroid Hormone Therapy for Older Adults with Subclinical Hypothyroidism, Copyright © 2017 Massachusetts Medical Society. Reprinted with permission