Show simple item record

dc.contributor.authorStott, David Jen
dc.contributor.authorRodondi, Nicolasen
dc.contributor.authorKearney, Patricia Men
dc.contributor.authorFord, Ianen
dc.contributor.authorWestendorp, Rudi GJen
dc.contributor.authorMooijaart, Simon Pen
dc.contributor.authorSattar, Naveeden
dc.contributor.authorAubert, Carole Een
dc.contributor.authorAujesky, Drahomiren
dc.contributor.authorBauer, Douglas Cen
dc.contributor.authorBaumgartner, Christineen
dc.contributor.authorBlum, Manuel Ren
dc.contributor.authorBrowne, John Pen
dc.contributor.authorByrne, Stephenen
dc.contributor.authorCollet, Tinh-Haien
dc.contributor.authorDekkers, Olaf Men
dc.contributor.authorden Elzen, Wendy PJen
dc.contributor.authorDu Puy, Robert Sen
dc.contributor.authorEllis, Grahamen
dc.contributor.authorFeller, Martinen
dc.contributor.authorFloriani, Carmenen
dc.contributor.authorHendry, Kirstyen
dc.contributor.authorHurley, Carolineen
dc.contributor.authorJukema, J Wouteren
dc.contributor.authorKean, Sharonen
dc.contributor.authorKelly, Mariaen
dc.contributor.authorKrebs, Danielleen
dc.contributor.authorLanghorne, Peteren
dc.contributor.authorMcCarthy, Gemmaen
dc.contributor.authorMcCarthy, Veraen
dc.contributor.authorMcConnachie, Alexen
dc.contributor.authorMcDade, Mairien
dc.contributor.authorMessow, Martinaen
dc.contributor.authorO'Flynn, Annemarieen
dc.contributor.authorO'Riordan, Daviden
dc.contributor.authorPoortvliet, Rosalinde KEen
dc.contributor.authorQuinn, Terence Jen
dc.contributor.authorRussell, Audreyen
dc.contributor.authorSinnott, Carolen
dc.contributor.authorSmit, Jan WAen
dc.contributor.authorVan Dorland, H Anetteen
dc.contributor.authorWalsh, Kieran Aen
dc.contributor.authorWalsh, Elaine Ken
dc.contributor.authorWatt, Torquilen
dc.contributor.authorWilson, Robbieen
dc.contributor.authorGussekloo, Jacobijnen
dc.contributor.authorTRUST Study Group,en
dc.date.accessioned2018-03-29T11:25:19Z
dc.date.available2018-03-29T11:25:19Z
dc.date.issued2017-06en
dc.identifier.issn0028-4793
dc.identifier.urihttps://www.repository.cam.ac.uk/handle/1810/274484
dc.description.abstractBACKGROUND: 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 .).
dc.format.mediumPrint-Electronicen
dc.languageengen
dc.subjectTRUST Study Groupen
dc.subjectHumansen
dc.subjectHypothyroidismen
dc.subjectFatigueen
dc.subjectThyrotropinen
dc.subjectThyroxineen
dc.subjectTreatment Failureen
dc.subjectDouble-Blind Methoden
dc.subjectQuality of Lifeen
dc.subjectAgeden
dc.subjectAged, 80 and overen
dc.subjectFemaleen
dc.subjectMaleen
dc.subjectIntention to Treat Analysisen
dc.titleThyroid Hormone Therapy for Older Adults with Subclinical Hypothyroidism.en
dc.typeArticle
prism.endingPage2544
prism.issueIdentifier26en
prism.publicationDate2017en
prism.publicationNameThe New England journal of medicineen
prism.startingPage2534
prism.volume376en
dc.identifier.doi10.17863/CAM.17715
dcterms.dateAccepted2017-03-21en
rioxxterms.versionofrecord10.1056/nejmoa1603825en
rioxxterms.versionVoR*
rioxxterms.licenseref.urihttp://www.rioxx.net/licenses/all-rights-reserveden
rioxxterms.licenseref.startdate2017-06en
dc.contributor.orcidRodondi, Nicolas [0000-0001-9083-6896]
dc.contributor.orcidKearney, Patricia M [0000-0001-9599-3540]
dc.contributor.orcidMooijaart, Simon P [0000-0003-3106-3568]
dc.contributor.orcidAubert, Carole E [0000-0001-8325-8784]
dc.contributor.orcidBlum, Manuel R [0000-0003-4638-775X]
dc.contributor.orcidCollet, Tinh-Hai [0000-0002-3243-1222]
dc.contributor.orcidDekkers, Olaf M [0000-0002-1333-7580]
dc.contributor.orcidden Elzen, Wendy PJ [0000-0002-6774-4077]
dc.contributor.orcidFeller, Martin [0000-0003-2519-836X]
dc.contributor.orcidSinnott, Carol [0000-0002-8620-7461]
dc.contributor.orcidWatt, Torquil [0000-0002-6001-7440]
dc.identifier.eissn1533-4406
rioxxterms.typeJournal Article/Reviewen


Files in this item

Thumbnail

This item appears in the following Collection(s)

Show simple item record