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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
- Source :
- Thyroid. 26:197-202
- Publication Year :
- 2016
- Publisher :
- Mary Ann Liebert Inc, 2016.
-
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.
- 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
Subjects
Details
- ISSN :
- 15579077 and 10507256
- Volume :
- 26
- Database :
- OpenAIRE
- Journal :
- Thyroid
- Accession number :
- edsair.doi.dedup.....4519ca1fe3950f61c010c162a7aa9c16
- Full Text :
- https://doi.org/10.1089/thy.2015.0422