Thyroid hormone therapy for older adults with subclinical hypothyroidism

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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.
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Massachusetts Medical Society
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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