A Double-Blind Placebo-Controlled Trial of Liquid Thyroxine Ingested at Breakfast: Results of the TICO study.

A Double-Blind Placebo-Controlled Trial of Liquid Thyroxine Ingested at Breakfast: Results of the TICO study.

Thyroid. 2015 Nov 20;

Authors: Cappelli C, Pirola I, Daffini L, Formenti A, Iacobello C, Cristiano A, Gandossi E, Agabiti Rosei E, Castellano M

Abstract
BACKGROUND: Levothyroxine (L-T4) is the recommended treatment for millions of hypothyroid patients. Current guidelines recommend that L-T4 tablets be taken in a fasting state, but inability to adhere to this often leads to poor therapy compliance.
METHODS: We conducted a randomized, double-blind, placebo-controlled, crossover trial in previously untreated hypothyroid patients randomly assigned to receive an oral solution of L-T4 either at least 30 minutes before breakfast or directly at breakfast time. Each patient completed two 6-week treatment periods, with different timing of active L-T4 administration: placebo before breakfast and active L-T4 at breakfast, or vice versa. At the end of each period, TSH, fT4 and fT3 were measured. The primary endpoint was to verify any difference in serum TSH levels whether consuming liquid L-T4 at breakfast or 30 minutes prior to breakfast.
RESULTS: A total of 77 patients (64/13 female/male, median age 45.4 ±13.7) completed the study. No statistically significant difference of serum TSH, fT4 and fT3 levels was observed whether L-T4 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 L-T4 administered, or on the post-treatment serum TSH values.
CONCLUSIONS: The TICO study suggests that a liquid L-T4 formulation can be ingested directly at breakfast, thus potentially improving therapeutic compliance. This observation is of considerable clinical relevance, since non-adherence to L-T4therapy requirements is more likely to cause variability in serum TSH concentrations.

PMID: 26586610 [PubMed - as supplied by publisher]

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