Thyroid hormone therapy for older adults with subclinical hypothyroidism

Show simple item record 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 J. C. McConnachie, Alex McDade, Mairi Messow, Martina O'Flynn, Anne Marie 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 2017-05-11T13:13:35Z 2017-05-11T13:13:35Z 2017-04-03
dc.identifier.citation Stott, D. J. et al. (2017) 'Thyroid Hormone Therapy for Older Adults with Subclinical Hypothyroidism'. New England Journal of Medicine, doi:10.1056/NEJMoa1603825 en
dc.identifier.startpage 1 en
dc.identifier.endpage 11 en
dc.identifier.issn 1533-4406
dc.identifier.issn 0028-4793
dc.identifier.doi 10.1056/NEJMoa1603825
dc.description.abstract 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. Full Text of Background... 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). Full Text of Methods... 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. Full Text of Results... CONCLUSIONS: Levothyroxine provided no apparent benefits in older persons with subclinical hypothyroidism. en
dc.format.mimetype application/pdf en
dc.language.iso en en
dc.publisher Massachusetts Medical Society en
dc.rights From New England Journal of Medicine, Stott et al, Thyroid Hormone Therapy for Older Adults with Subclinical Hypothyroidism, Copyright © 2017 Massachusetts Medical Society. Reprinted with permission en
dc.subject Subclinical hypothyroidism en
dc.subject Levothyroxine en
dc.subject Clinical trial en
dc.title Thyroid hormone therapy for older adults with subclinical hypothyroidism en
dc.type Article (peer-reviewed) en
dc.internal.authorcontactother Patricia Kearney, Epidemiology & Public Health, University College Cork, Cork, Ireland. +353-21-490-3000 Email: en
dc.internal.availability Full text available en Access to this article is restricted until 6 months after publication by the request of the publisher. en 2017-10-02 2017-05-11T11:53:58Z
dc.description.version Published Version en
dc.internal.rssid 394616053
dc.contributor.funder Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung en
dc.contributor.funder European Commission en
dc.contributor.funder Seventh Framework Programme en
dc.contributor.funder Schweizerische Herzstiftung en
dc.contributor.funder Velux Stiftung en
dc.description.status Peer reviewed en
dc.identifier.journaltitle New England Journal of Medicine en
dc.internal.copyrightchecked No !!CORA!! en
dc.internal.licenseacceptance Yes en
dc.internal.IRISemailaddress en
dc.internal.bibliocheck Published online only. April 2017. Check if publhed in print journal and adjust citation details if required. en
dc.relation.project info:eu-repo/grantAgreement/EC/FP7::SP1::HEALTH/278148/EU/Multi-modal effects of thyroid hormone replacement for untreated older adults with subclinical hypothyroidism; a randomised placebo-controlled trial/TRUST en

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