6/30/23, 2:21 AM TRUST Pathway Feedback Search Clinical Topics Home Studies TRUST TRUST Disease Disease Hypothyroidism Subclinical hypothyroidism Trial question What is the effect of levothyroxine in older patients with subclinical hypothyroidism? Study design Multi-center Double blinded RCT Population Characteristics of study participants 54.0% female N = 737 46.0% male 737 patients (396 female, 341 male) Inclusion criteria: adult patients 65 years of age who had persisting subclinical hypothyroidism, with thyrotropin level of 4.60-19.99 mlU/L and free thyroxine level within reference range Key exclusion criteria: current prescription for levothyroxine, antithyroid drugs, amiodarone, or lithium, thyroid surgery or receipt of radioactive iodine within the previous 12 months, dementia, hospitalization for a major illness or an elective surgery within the previous 4 weeks, acute coronary syndrome within the previous 4 weeks, and terminal illness Interventions N=368 levothyroxine (starting dose of 50 g daily or 25 g if the body weight was < 50 kg or patient had coronary heart disease, with dose adjustment according to thyrotropin level) N=369 placebo (mock dose adjustment) https://web.pathway.md/studies/recktT7ePkYSxNhYA 1/2 6/30/23, 2:21 AM TRUST Pathway Primary outcome Change in Tiredness score at 12 months 3.8 3.8 3.2 2.8 1.9 0.9 No significant difference 0.0 Levothyroxine Placebo No significant difference in change in Tiredness score at 12 months (3.8 vs. 3.2; AD 0.4, 95% CI -2.1 to 2.9) Safety outcomes No significant differences in incidence of serious adverse events of special interest (AF, HF, fracture, or new diagnosis of osteoporosis). Conclusion In adult patients 65 years of age who had persisting subclinical hypothyroidism, with thyrotropin level of 4.60-19.99 mlU/L and free thyroxine level within reference range, levothyroxine was not superior to placebo with respect to change in Tiredness score at 12 months. Reference Stott DJ, Rodondi N, Kearney PM et al. Thyroid Hormone Therapy for Older Adults with Subclinical Hypothyroidism. N Engl J Med. 2017 Jun 29;376(26):2534-2544. Open reference URL https://web.pathway.md/studies/recktT7ePkYSxNhYA 2/2