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Effects of discontinuation of levothyroxine treatment in older adults: a self-controlled study

Projectomschrijving

Gebruik van schildklierhormoon optimaal?

Veel ouderen gebruiken tabletten met schildklierhormoon: levothyroxine. Deze behandeling is meestal levenslang. Vraag is of alle ouderen optimaal behandeld worden. Met het ouder worden kan het lichaam minder levothyroxine nodig hebben en stijgt de kans op overbehandeling. Soms geldt de oorspronkelijke indicatie niet meer. Daarnaast leidt behandeling op latere leeftijd niet altijd tot betere gezondheid. 

Doel

Het verbeteren van behandeling van schildklierstoornissen bij 60-plussers die levothyroxine gebruiken: onderzoeken welke deelnemers levothyroxine geleidelijk kunnen afbouwen en stoppen met behoud van gezondheid, welbevinden en normale schildklierfunctie.

Werkwijze

Onder begeleiding van de eigen huisarts wordt bij 360 deelnemers van 60 jaar en ouder levothyroxine stapsgewijs afgebouwd onder controle van de schildklierfunctie. Niet iedereen kan meedoen: bijvoorbeeld als de schildklier is verwijderd, bestraald of behandeld met radioactief jodium. 

Producten

Titel: Patient-reported Satisfaction with Thyroid Hormone Replacement Therapy for Subclinical Hypothyroidism in Older Adults – a Nested Study within Two Randomized Controlled Trials
Auteur: A Janneke Ravensberg, RKE Poortvliet, RS Du Puy, N Rodondi, MR Blum, PM Kearney, VJC Mc Carthy, TJ Quinn, OM Dekkers, JW Jukema, SP Mooijaart, JG Gussekloo
Titel: Effects of Discontinuation of Levothyroxine Treatment in Older Adults: Protocol for a Self-controlled Trial
Auteur: A Janneke Ravensberg, RKE Poortvliet, RS Du Puy, OM Dekkers, SP Mooijaart, JG Gussekloo
Titel: Patient reported satisfaction with levothyroxine therapy for subclinical hypothyroidism in older adults
Auteur: Janneke Ravensberg, Robert Du Puy, Rosalinde Poortvliet, Simon Mooijaart, Jacobijn Gussekloo on behalf of the TRUST consortium
Titel: Effects of discontinuation of levothyroxine treatment in older adults: protocol for a self-controlled trial
Auteur: A Janneke Ravensberg, Rosalinde K E Poortvliet, Robert S Du Puy, Olaf M Dekkers, Simon P Mooijaart, Jacobijn Gussekloo
Magazine: BMJ Open
Link: https://bmjopen.bmj.com/content/13/4/e070741
Titel: Wie zijn de junior-onderzoekers achter de LUMC-onderzoekslijn rondom het schildklierhormoon?
Auteur: Dr. M. de Waal
Link: https://www.lumc.nl/org/pheg/over-de-afdeling-pheg/nieuwsbrieven
Titel: Release studie
Auteur: Janneke Ravensberg, Rosalinde Poortvliet, Jacobijn Gussekloo, Andries de Man
Link: https://www.releasestudie.nl/

Verslagen


Samenvatting van de aanvraag

RELEVANCE Many older persons in the Netherlands use levothyroxine (2015: >160.000 aged 65+), and often have been using levothyroxine for a very long time. Initial indications for treatment are often not well registered, inaccurate or even inappropriate. Levothyroxine treatment is indicated for patients with overt hypothyroidism (high TSH, low fT4). For subclinical hypothyroidism (high TSH, normal fT4), the most common thyroid disorder in older people (3-18% aged 65+), guidelines vary. Some guidelines recommend to start therapy in all cases, some recommend not to start and others advise to try treatment in case of relevant symptoms or TSH>10 mU/L. Recently, in the TRUST trial, we showed that levothyroxine treatment was not clinically beneficial in older persons with subclinical hypothyroidism. Given the high prevalence of levothyroxine use in old age, the often unclear treatment indications, the lack of evidence for beneficial effects of treatment and the health risks associated with overtreatment, we hypothesize that discontinuation of levothyroxine is feasible in many older persons without negative consequences, diminishing the burden of polypharmacy in older persons and contributing to a decrease in healthcare costs. AIMS OF THIS STUDY Primary aim: 1) To investigate what proportion of older (60-plus) levothyroxine users can successfully be withdrawn from levothyroxine treatment without a need for treatment defined as having normal fT4 levels and TSH levels <10 mU/L. Secondary aims: 1) To study the effect of discontinuing levothyroxine on a) thyroid-specific quality of life, b) general health and c) treatment satisfaction for medication by comparing validated questionnaire data before and after stopping in a self-controlled design. 2) To study what proportion of older (60-plus) levothyroxine users achieve a substantial dose lowering after one year. 3) To study the demographic and clinical characteristics of the older persons willing to discontinue levothyroxine and the older persons that successfully reduce treatment dosage. 4) To study the characteristics of older persons that General Practitioners (GPs) consider safe for withdrawing thyroid medication, and medical reasons not to discontinue treatment. 5) To get insight in how often GPs stop levothyroxine treatment (or lower dose) in usual care (using Routine Medical Care data). DESIGN A self-controlled intervention study investigating stepwise levothyroxine treatment discontinuation in patients >=60 years with levothyroxine treatment for more than one year. PROCEDURES • STEP 1 = inviting GPs to participate. We will prepare an online course (‘webinar’) for information and instruction. • STEP 2 = GPs identify eligible participants by selection from electronic medical record (EMR). Inclusion criteria: 1) aged =60 years, and 2) using levothyroxine mono-therapy (ATC: H03AA01) continuously for >=1 year. • STEP 3 = for all patients identified by the selection, the GP will screen their EMR for medical safety exclusion criteria • STEP 4 = eligible patients are invited by their GP to participate. • STEP 5 = Intervention phase 5.1 Pre-intervention phase: Participants enter the study with pre-baseline measurements (T=-12 weeks) in which treatment with levothyroxine is continued per usual care with unadjusted daily routine. Pre-baseline measurements: small set of questionnaires + thyroid function laboratory test. 5.2 Discontinuation phase: the participant will start lowering the dose of levothyroxine at T=0 guided by the GP according to the study-protocol. Per 6 weeks, the daily dose of levothyroxine is halved until the dose of 25 mcg is reached. Then, in the final step, the medication will be discontinued completely if the laboratory results are still normal. 5.3 follow-up phase At 12 months, EMR data, questionnaires and laboratory assessment will be collected. At 24 months, EMR data are extracted. OUTCOME MEASURES The primary outcome is the proportion of participants that successfully withdraw their thyroid medication without need for treatment defined as having normal fT4 levels and TSH levels <10 mU/L at 52 weeks after start of the intervention. Secondary outcome measures •ThyPRO39, to measure thyroid-related quality of life including somatic, psychological and social domains •Treatment Satisfaction Questionnaire for Medication version II (TSQM), to measure treatment satisfaction for medication •EQ5D questionnaire to measure general health SAFETY Safety of participants will be monitored by an independent Data Safety and Monitoring Board and judged according to pre-defined stopping rules. The GP is responsible for monitoring the clinical safety of the participant (usual care). ADDITIONAL STUDY in Routine Medical Care data To get insight in how often GPs stop levothyroxine treatment (or lower dose) in usual care, an observational sub-study is performed using Routine Medical Care data of the ELAN data warehouse (approx. 60.000 patients aged 60-plus from 150 general practices).

Kenmerken

Projectnummer:
839110026
Looptijd: 81%
Looptijd: 81 %
2018
2025
Gerelateerde subsidieronde:
Projectleider en penvoerder:
dr. R.K.E. Poortvliet MD PhD
Verantwoordelijke organisatie:
Leids Universitair Medisch Centrum
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