TRUST
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
46.0% male
N = 737
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 fT4 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 mcg daily or 25 mcg if the body weight was < 50 kg or patient had coronary artery disease, with dose adjustment according to thyrotropin level).
N=369 placebo (mock dose adjustment).
Primary outcome
Change in Hypothyroid Symptoms score at 12 months
16.6 points
16.7 points
16.7 points
12.5 points
8.3 points
4.2 points
0.0 points
Levothyroxine
Placebo
No significant
difference ↔
No significant difference in change in Hypothyroid Symptoms score at 12 months (16.6 points vs. 16.7 points).
Secondary outcomes
No significant difference in change in Tiredness score at 12 months (3.8 points vs. 3.2 points; AD 0.4 points, 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 fT4 level within reference range, levothyroxine was not superior to placebo with respect to change in Hypothyroid Symptoms 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.
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