Thyroid hormone therapy for older adults with subclinical hypothyroidism

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) (PMID:28402245)

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. 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 <50kg 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). 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. Conclusions: Levothyroxine provided no apparent benefits in older persons with subclinical hypothyroidism. (Funded by European Union FP7 and others; TRUST ClinicalTrials.gov number, NCT01660126.)

• Item Type: Articles
• Status: Published
• Refereed: Yes
• Glasgow Author(s) Enlighten ID: Wilson, Mr Robbie and Messow, Dr Martina and McConnachie, Professor Alex and Poortvliet, Dr Rosalinde and Hendry, Miss Kirsty and Langhorne, Professor Peter and Kean, Ms Sharon and Quinn, Professor Terry and Stott J, Professor David and Sattar, Professor Naveed and Ford, Professor Ian and McDade, Mrs Mairi and Ellis, Dr Graham
• Authors: Stott, D. J., Rodondi, N., Kearney, P. M., Ford, I., Westendorp, R. G.J., Mooijaart, S. P., Sattar, N., Aubert, C. E., Aujesky, D., Bauer, D. C., Baumgartner, C., Blum, M. R., Browne, J. P., Byrne, S., Collet, T.-H., Dekkers, O. M., den Elzen, W. P.J., Du Puy, R. S., Ellis, G., Feller, M., Floriani, C., Hendry, K., Hurley, C., Jukema, J. W., Kean, S., Kelly, M., Krebs, D., Langhorne, P., McCarthy, G., McCarthy, V., McConnachie, A., McDade, M., Messow, M., O’Flynn, A., O’Riordan, D., Poortvliet, R. K.E., Quinn, T. J., Russell, A., Sinnott, C., Smit, J. W.A., Van Dorland, H. A., Walsh, K. A., Walsh, E. K., Watt, T., Wilson, R., and Gussekloo, J.
• Subjects: R Medicine > R Medicine (General)
• College/School: College of Medical Veterinary and Life Sciences > School of Cardiovascular & Metabolic Health; College of Medical Veterinary and Life Sciences > School of Health & Wellbeing > Robertson Centre
• Journal Name: New England Journal of Medicine
• Publisher: Massachusetts Medical Society
• ISSN: 0028-4793
• ISSN (Online): 1533-4406
• Published Online: 03 April 2017
• Copyright Holders: Copyright © 2017 Massachusetts Medical Society
• First Published: First published in New England Journal of Medicine 376(26):2534-2544
• Publisher Policy: Reproduced in accordance with the publisher copyright policy