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, TRUST Study Group
The New England journal of medicine · 2017 · PMID 28402245 · 인용 488
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 <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).
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 .).