TY - JOUR
T1 - Thyroid Hormone Therapy for Older Adults with Subclinical Hypothyroidism
AU - Stott, David J.
AU - Rodondi, Nicolas
AU - Kearney, Patricia M.
AU - Ford, Ian
AU - Westendorp, Rudi G. J.
AU - Mooijaart, Simon P.
AU - Sattar, Naveed
AU - Aubert, Carole E.
AU - Aujesky, Drahomir
AU - Bauer, Douglas C.
AU - Baumgartner, Christine
AU - Blum, Manuel R.
AU - Browne, John P.
AU - Byrne, Stephen L.
AU - Collet, Tinh-Hai
AU - Dekkers, Olaf M.
AU - den Elzen, Wendy P. J.
AU - Du Puy, Robert S.
AU - Ellis, Graham
AU - Feller, Martin
AU - Floriani, Carmen
AU - Hendry, Kirsty
AU - Hurley, Caroline
AU - Jukema, J. Wouter
AU - Kean, Sharon
AU - Kelly, Maria
AU - Krebs, Danielle
AU - Langhorne, Peter
AU - McCarthy, Gemma
AU - McCarthy, Vera
AU - McConnachie, Alex
AU - McDade, Mairi
AU - Messow, Martina
AU - O’Flynn, Annemarie
AU - O’Riordan, David
AU - Poortvliet, Rosalinde K. E.
AU - Quinn, Terence J.
AU - Russell, Audrey
AU - Sinnott, Carol
AU - Smit, Jan W. A.
AU - Van Dorland, H. Anette
AU - Walsh, Kieran A.
AU - Walsh, Elaine K.
AU - Watt, Torquil
AU - Wilson, Robbie
AU - Gussekloo, Jacobijn
AU - the TRUST Study Group
PY - 2017/6/29
Y1 - 2017/6/29
N2 - 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.)
AB - 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.)
U2 - 10.1056/NEJMoa1603825
DO - 10.1056/NEJMoa1603825
M3 - Journal article
C2 - 28402245
VL - 376
SP - 2534
EP - 2544
JO - New England Journal of Medicine
JF - New England Journal of Medicine
SN - 0028-4793
IS - 26
ER -