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

Abstract

Objective: While radioiodine therapy is commonly used for treating Graves' disease, a prolonged and clinical hypothyroidism may result in disabling symptoms leading to deterioration of quality of life (QoL) of patients. Introducing levothyroxine (LT 4 ) treatment in the early post-therapeutic period may be an interesting approach to limit this phenomenon. Methods: A multicenter, prospective, open-label randomized controlled trial enrolled 94 patients with Graves' hyperthyroidism randomly assigned to the experimental group (nZ46) (group A: early prophylactic LT 4 treatment) or the control group (nZ48) (group B: standard follow-up). The primary endpoint was the 6-month QoL. The secondary endpoints were other QoL scores such as Graves' ophthalmopathy (GO) outcomes, thyroid function tests and safety. Results: The primary endpoint at 6 months was achieved: the mental composite score (MCS) of Short Form 36 (SF-36) was significantly higher in group A compared to group B (PZ0.009). Four other dimension scores of the SF-36 and four dimension scores of the thyroid-specific patient-reported outcome (ThyPRO) significantly differed between the two groups, indicating better QoL in group A. After adjustment for variables, the early LT 4 administration strategy was found as an independent factor for only two scores of SF-36: the MCS and the general health (GH) score. There were no differences in GO, final thyroid status and changes in the anti-TSH receptor antibodies (TRAbs) levels between the two groups. No adverse cardiovascular event was reported. Conclusion: Early LT 4 administration post-radioactive iodine (RAI) could represent a safe potential benefit for patients with regard to QoL. The optimal strategy taking into account administered RAI activities and LT 4 treatment dosage and timing remains to be determined.

Development of a core outcome set for amblyopia, strabismus and ocular motility disorders: a review to identify outcome measures

“…HRQoL outcome measures were mostly prominent in thyroid eye disease studies [82, 84, 91, 95–97, 104, 107, 109–111, 115, 116], nevertheless they were also scattered in other sub-conditions; accommodation and convergence disorders [125], ocular myasthenia [142] and central causes of eye movement disorders [80, 81].…”

“…Multiple time points [82, 92, 94, 96, 97, 100, 101, 103, 115, 118, 121, 128] or spans of follow up were often given [83, 84, 99, 105, 111, 113, 126, 139]. However 6 months [82, 83, 97, 99, 103, 104, 111] and 12 months [82, 97, 98, 103, 107, 113] were frequent timings given in thyroid eye disease studies. Twelve weeks timing was common for accommodation and convergence disorders [117, 118, 125, 128].…”

Treatment of adult Graves’ disease

“…Likewise, the benefit of early thyroxine treatment at 2 weeks after administration is unproven [116,118,137]. By preventing post-treatment thyroid failure, it might reduce the risk of aggravating orbitopathy [137], but this was not confirmed in a recent French multicenter study, which nevertheless found improved quality of life under levothyroxine-4 [118]; however, in this study, patients were carefully selected and orbital events were few.…”

“…), impaired quality of life [114,115] and, even more importantly, onset or aggravation of Graves' ophthalmopathy [116,117]. A recent study showed that, in ablative treatment, systematic early levothyroxine therapy to prevent secondary hypothyroidism improved quality of life, but did not reduce onset or aggravation of ophthalmopathy, which was found in only a very few cases [118]. The hypothalamus-pituitary axis may take some weeks to recover, and TSH often remains inhibited for 4-6 weeks [113].…”

Adaptation and cross-cultural validation of the Spanish version of the Thyroid-Related Quality-of-Life Patient-Reported Outcome questionnaire

“…In recent years, the ThyPRO has been applied to the clinical investigation of different issues related to thyroid disorders, such as the role of autoimmunity markers in the HRQoL of patients with primary hypothyroidism 14 or the impact of different treatments on HRQoL among patients with multinodular goiter, Graves' disease and subclinical hypothyroidism [15][16][17][18][19][20][21][22][23] . Furthermore, it is being used as the main variable outcome in ongoing large-scale clinical trials evaluating emergent therapies for autoimmune thyroid dissorders 24 .…”