Thyroid Hormone Therapy for Older Adults with Subclinical Hypothyroidism.

Stott, DJ; Rodondi, N; Kearney, PM; Ford, I; Westendorp, RG; Mooijaart, SP; Sattar, N; Aubert, CE; Aujesky, D; Bauer, DC; +37 more...Baumgartner, C; Blum, MR; Browne, JP; Byrne, S; Collet, T; Dekkers, OM; den Elzen, WP; Du Puy, RS; Ellis, G; Feller, M; Floriani, C; Hendry, K; Hurley, C; Jukema, JW; 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, RK; Quinn, TJ; Russell, A; Sinnott, C; Smit, JW; Van Dorland, HA; Walsh, KA; Walsh, EK; Watt, T; Wilson, R; Gussekloo, J; TRUST Study Group and (2017) Thyroid Hormone Therapy for Older Adults with Subclinical Hypothyroidism. The New England journal of medicine, 376 (26). pp. 2534-2544. ISSN 0028-4793 DOI: 10.1056/NEJMoa1603825
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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 .).


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