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

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