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Hypothyroidism is a common disease affecting up to 10% of the adult population, disproportionally more frequent in females. This condition is associated with dyslipidemia and increased cardiovascular risk1-4, which is not completely reversed following therapy. Despite its prevalence, there is a surprising lack of evidence-based information on the optimal treatment of hypothyroidism, likely because thyroid hormone replacement treatments have been in place well before the establishment of the current regulatory framework. This is a randomized, three-arm, double-blind, controlled, escalating dose parallel pilot study in which 90 patients with hypothyroidism (30 each group) will be randomized to six months of treatment with LT4/placebo, LT4/LT3 with LT3 administered once daily, or LT4/LT3 with LT3 administered twice daily. This study will identify information on feasibility, dosing, treatment scheme, and effect size of end-organ outcomes. If successful, this will inform future clinical trials that will provide evidence supporting or negating the use of LT4/LT3 combination therapy to treat hypothyroidism.
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