Thyroid Hormone Therapy for Older Adults with Subclinical Hypothyroidism

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  • David J. Stott
  • Nicolas Rodondi
  • Patricia M. Kearney
  • Ian Ford
  • Westendorp, Rudi GJ
  • 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
  • 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.)

TidsskriftNew England Journal of Medicine
Udgave nummer26
Sider (fra-til)2534-2544
Antal sider11
StatusUdgivet - 29 jun. 2017

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