1. A Double-Blind Placebo-Controlled Trial of Liquid Thyroxine Ingested at Breakfast: Results of the TICO Study
- Author
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Carlo Cappelli, Annamaria Formenti, C. Iacobello, Alessandra Cristiano, Linda Daffini, Maurizio Castellano, Enrico Agabiti Rosei, Ilenia Pirola, and Elena Gandossi
- Subjects
Adult ,Male ,endocrine system ,medicine.medical_specialty ,Time Factors ,Endocrinology, Diabetes and Metabolism ,Medicine (all) ,Endocrinology ,Levothyroxine ,Placebo-controlled study ,Thyrotropin ,030209 endocrinology & metabolism ,Thyroid Function Tests ,Placebo ,Drug Administration Schedule ,Medication Adherence ,law.invention ,03 medical and health sciences ,Therapy compliance ,0302 clinical medicine ,Double-Blind Method ,Hypothyroidism ,Randomized controlled trial ,law ,Internal medicine ,medicine ,Clinical endpoint ,Humans ,Breakfast ,Cross-Over Studies ,business.industry ,digestive, oral, and skin physiology ,Fasting ,Middle Aged ,Crossover study ,Diabetes and Metabolism ,Thyroxine ,Treatment Outcome ,Before Breakfast ,030220 oncology & carcinogenesis ,Triiodothyronine ,Female ,business ,hormones, hormone substitutes, and hormone antagonists ,medicine.drug - Abstract
Levothyroxine (LT4) is the recommended treatment for millions of hypothyroid patients. Current guidelines recommend that LT4 tablets be taken in a fasting state, but inability to adhere to this often leads to poor therapy compliance.A randomized, double-blind, placebo-controlled, crossover trial was conducted in previously untreated hypothyroid patients randomly assigned to receive an oral solution of LT4 either at least 30 minutes before breakfast or directly at breakfast time. Each patient completed two six-week treatment periods, with different timing of active LT4 administration: placebo before breakfast and active LT4 at breakfast, or vice versa. At the end of each period, thyrotropin (TSH), free thyroxine (fT4), and free triiodothyronine (fT3) were measured. The primary endpoint was to verify any difference in serum TSH levels whether consuming liquid LT4 at breakfast or 30 minutes prior to breakfast.A total of 77 patients (64 females; median age 45.4 ± 3.7 years) completed the study. No statistically significant differences in serum TSH, fT4, or fT3 levels were observed whether LT4 was taken at breakfast or 30 minutes before, in a fasting state. No significant effect from the sequence of regimens, breakfast composition, and/or concomitantly administered drugs was observed on the dose of LT4 administered, or on the post-treatment serum TSH values.The TICO study suggests that a liquid LT4 formulation can be ingested directly at breakfast, thus potentially improving therapeutic compliance. This observation is of considerable clinical relevance, since non-adherence to LT4 therapy requirements is more likely to cause variability in serum TSH concentrations.
- Published
- 2016
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