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

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.