Thyroid Hormone Therapy for Older Adults with Subclinical Hypothyroidism
In: Stott , D J , Rodondi , N , Kearney , P M , Ford , I , Westendorp , R G J , Mooijaart , S P , Sattar , N , Aubert , C E , Aujesky , D , Bauer , D C , Baumgartner , C , Blum , M R , Browne , J P , Byrne , S L , Collet , T-H , Dekkers , O M , den Elzen , W P J , Du Puy , R S , Ellis , G , Feller , M , Floriani , C , Hendry , K , Hurley , C , Jukema , J W , 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 , R K E , Quinn , T J , Russell , A , Sinnott , C , Smit , J W A , Van Dorland , H A , Walsh , K A , Walsh , E K , Watt , T , Wilson , R , Gussekloo , J & the TRUST Study Group 2017 , ' Thyroid Hormone Therapy for Older Adults with Subclinical Hypothyroidism ' , New England Journal of Medicine , vol. 376 , no. 26 , pp. 2534-2544 . https://doi.org/10.1056/NEJMoa1603825
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.)