Quality of life, clinical outcomes and safety of early prophylactic ă levothyroxine administration in patients with Graves' hyperthyroidism ă undergoing radioiodine therapy: a randomized controlled study

David Taïeb, Claire Bournaud, Marie-Claude Eberle, Bogdan Catargi, Claire Schvartz, Marie-Béatrice Cavarec, Isabelle Faugeron, Marie-Elisabeth Toubert, Danielle Benisvy, Cendrine Archange, Olivier Mundler, Philippe Caron, Ahmad Esmaeel Abdullah and Karine Baumstarck
Additional contact information
David Taïeb: Département de radiologie - CHU Nantes - Centre Hospitalier Universitaire de Nantes = Nantes University Hospital
Claire Bournaud: Département de Médecine Nucléaire - CHU de Lyon - CHU de Lyon
Bogdan Catargi: CBMN - Chimie et Biologie des Membranes et des Nanoobjets - UB - Université de Bordeaux - ENITAB - École Nationale d'Ingénieurs des Travaux Agricoles - Bordeaux - INC-CNRS - Institut de Chimie - CNRS Chimie - CNRS - Centre National de la Recherche Scientifique
Claire Schvartz: FRANCIM - Réseau des registres français du cancer
Marie-Béatrice Cavarec: Department of Nuclear Medicine - CHRU Brest - Centre Hospitalier Régional Universitaire de Brest
Olivier Mundler: TIMONE - Hôpital de la Timone [CHU - APHM], Service de médecine nucléaire [Marseille] - Université de la Méditerranée - Aix-Marseille 2 - APHM - Assistance Publique - Hôpitaux de Marseille - TIMONE - Hôpital de la Timone [CHU - APHM]
Philippe Caron: Trigone-CIREL - CIREL - Centre Interuniversitaire de Recherche en Education de Lille - ULR 4354 - Université de Lille
Karine Baumstarck: AMU - Aix Marseille Université

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Abstract: Objective: While radioiodine therapy is commonly used for treating ă Graves' disease, a prolonged and clinical hypothyroidism may result in ă disabling symptoms leading to deterioration of quality of life (QoL) of ă patients. Introducing levothyroxine (LT4) treatment in the early ă post-therapeutic period may be an interesting approach to limit this ă phenomenon. ă Methods: A multicenter, prospective, open-label randomized controlled ă trial enrolled 94 patients with Graves' hyperthyroidism randomly ă assigned to the experimental group (n=46) (group A: early prophylactic ă LT4 treatment) or the control group (n=48) (group B: standard ă follow-up). The primary endpoint was the 6-month QoL. The secondary ă endpoints were other QoL scores such as Graves' ophthalmopathy (GO) ă outcomes, thyroid function tests and safety. ă Results: The primary endpoint at 6 months was achieved: the mental ă composite score (MCS) of Short Form 36 (SF-36) was significantly higher ă in group A compared to group B (P=0.009). Four other dimension scores of ă the SF-36 and four dimension scores of the thyroid-specific ă patient-reportedoutcome (ThyPRO) significantly differed between the two ă groups, indicating better QoL in group A. After adjustment for ă variables, the early LT4 administration strategy was found as an ă independent factor for only two scores of SF-36: the MCS and the general ă health (GH) score. There were no differences in GO, final thyroid status ă and changes in the anti-TSH receptor antibodies (TRAbs) levels between ă the two groups. No adverse cardiovascular event was reported. ă Conclusion: Early LT4 administration post-radioactive iodine (RAI) could ă represent a safe potential benefit for patients with regard to QoL. The ă optimal strategy taking into account administered RAI activities and LT4 ă treatment dosage and timing remains to be determined.

Keywords: Quality (search for similar items in EconPapers)
Date: 2016-04
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Published in European Journal of Endocrinology, 2016, 174 (4), pp.491-502. ⟨10.1530/EJE-15-1099⟩

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Persistent link: https://EconPapers.repec.org/RePEc:hal:journl:hal-01482520

DOI: 10.1530/EJE-15-1099

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