TSH evaluation in hypothyroid patients assuming liquid levothyroxine at breakfast or 30 min before breakfast
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To compare TSH levels of hypothyroid patients treated with liquid LT4 at breakfast or 30 min before breakfast.
Patients and methods
Subjects, aged 18–75 years old, were eligible if they presented hypothyroidism, due to Hashimoto’s thyroiditis or after thyroidectomy for proven benign goiter. Seven hundred ninety-eight patients were recruited and enrolled in the study. Thirty-seven subjects withdrew from the trial. A total of 761 patients (mean age 46.2 ± 10.8 years) completed the study. The starting dose of LT4 was determined through clinical judgment, taking into account TSH levels, estimated residual thyroid function, age, body weight and comorbidities. All patients underwent TSH, fT4, and fT3 evaluation to verify achievement of euthyroidism with their initial fasting state assumption of LT4 after 8 weeks of therapy. If euthyroidism was not achieved, an appropriately adjusted LT4 dose was administered for 8 weeks, after which thyroid function parameters were checked again. If euthyroidism was achieved, the patients were asked to take LT4 at breakfast and hormone levels were checked again after 6 months.
At the end of the study period, no significant differences in serum TSH level were observed whether LT4 was ingested at breakfast or 30 min prior in a fasting state: 2.61 ± 1.79 vs. 2.54 ± 1.86 mIU/L, respectively (p = 0.455).
This study confirms in a large set of patients that a liquid LT4 formulation can be taken directly at breakfast and potentially improve therapeutic compliance.
KeywordsLiquid levothyroxine Hypothyroidism TSH Levothyroxine formulation
We thank the patients who volunteered to participate in this study.
Compliance with Ethical Standards
Any no funds have been provided for this study.
Conflict of interest
The authors declare that they have no conflict of interest.
All procedures performed in the study involving human participants were in accordance with the ethical standards of the institutional ethics committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
Informed consent was obtained from all individual participants included in the study.
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