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; ... (2017). Thyroid Hormone Therapy for Older Adults with Subclinical Hypothyroidism. New England journal of medicine NEJM, 376(26), pp. 2534-2544. Massachusetts Medical Society MMS 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 .).

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of General Internal Medicine (DAIM) > Clinic of General Internal Medicine
04 Faculty of Medicine > Medical Education > Institute of General Practice and Primary Care (BIHAM)
04 Faculty of Medicine > Department of General Internal Medicine (DAIM) > Clinic of General Internal Medicine > Centre of Competence for General Internal Medicine

UniBE Contributor:

Rodondi, Nicolas; Aubert, Carole Elodie; Aujesky, Drahomir; Baumgartner, Christine; Blum, Manuel; Feller, Martin; Floriani, Carmen; Krebs, Danielle and van Dorland, Hendrika Anette

Subjects:

600 Technology > 610 Medicine & health
300 Social sciences, sociology & anthropology > 360 Social problems & social services

ISSN:

0028-4793

Publisher:

Massachusetts Medical Society MMS

Language:

English

Submitter:

Doris Kopp Heim

Date Deposited:

25 Apr 2017 15:27

Last Modified:

03 Dec 2018 15:36

Publisher DOI:

10.1056/NEJMoa1603825

PubMed ID:

28402245

BORIS DOI:

10.7892/boris.99500

URI:

https://boris.unibe.ch/id/eprint/99500

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