Thyroid hormone therapy for older adults with subclinical hypothyroidism
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.; Baumgartner, Christine; Blum, Manuel R.; Browne, John P.; Byrne, Stephen; Collet, Tinh-Hai; Dekkers, Olaf M.; den Elzen, Wendy P.J.; Du Puy, Robert S.; Ellis, Graham; Feller, Martin; Floriani, Carmen; Hendry, Kirsty; Hurley, Caroline; Jukema, J. Wouter; Kean, Sharon; Kelly, Maria; Krebs, Danielle; Langhorne, Peter; McCarthy, Gemma; McCarthy, Vera; McConnachie, Alex; McDade, Mairi; Messow, Martina; O'Flynn, Annemarie; O'Riordan, David; Poortvliet, Rosalinde K.E.; Quinn, Terence J; Russell, Audrey; Sinnott, Carol; Smit, Jan W.A.; Van Dorland, H. Anette; Walsh, Kieran A.; Walsh, Elaine K.; Watt, Torquil; Wilson, Robbie; Gussekloo, Jacobijn
Date:
2017-04-03
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
Full text restriction information:
Access to this article is restricted until 6 months after publication by the request of the publisher.
Restriction lift date:
2017-10-02
Citation:
Stott, D. J. et al. (2017) 'Thyroid Hormone Therapy for Older Adults with Subclinical Hypothyroidism'. New England Journal of Medicine, doi:10.1056/NEJMoa1603825
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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