Thyroid Hormone Therapy for Older Adults with Subclinical Hypothyroidism

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David J. Stott, Nicolas Rodondi, Patricia M. Kearney, Ian Ford, Rudi G. J. Westendorp, Simon P. Mooijaart, Naveed Sattar, Carole E. Aubert, Drahomir Aujesky, Douglas C. Bauer, Christine Baumgartner, Manuel R. Blum, John P. Browne, Stephen L. Byrne, Tinh-Hai Collet, Olaf M. Dekkers, Wendy P. J. den Elzen, Robert S. Du Puy, Graham Ellis, Martin Feller & 27 more Carmen Floriani, Kirsty Hendry, Caroline Hurley, J. Wouter Jukema, Sharon Kean, Maria Kelly, Danielle Krebs, Peter Langhorne, Gemma McCarthy, Vera McCarthy, Alex McConnachie, Mairi McDade, Martina Messow, Annemarie O’Flynn, David O’Riordan, Rosalinde K. E. Poortvliet, Terence J. Quinn, Audrey Russell, Carol Sinnott, Jan W. A. Smit, H. Anette Van Dorland, Kieran A. Walsh, Elaine K. Walsh, Torquil Watt, Robbie Wilson, Jacobijn Gussekloo, the TRUST Study Group

BACKGROUND: The use of levothyroxine to treat subclinical hypothyroidism is controversial. We aimed to determine whether levothyroxine provided clinical benefits in older personswith 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 <50 kg or the patient had coronary heart disease), with dose adjustment according to thethyrotropin level; 369 patients were assigned to receive placebo with mock dose adjustment. The two primary outcomes were the change in the Hypothyroid Symptomsscore 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 with3.63 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 Symptomsscore (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 Tirednessscore (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.govnumber, NCT01660126.)

Original languageEnglish
JournalNew England Journal of Medicine
Volume376
Issue number26
Pages (from-to)2534-2544
Number of pages11
ISSN0028-4793
DOIs
Publication statusPublished - 29 Jun 2017

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