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Cited by 30Thyroid Disorders and TreatmentsThyroid and Parathyroid SurgeryThyroid Cancer Diagnosis and Treatment

Timing of breakfast does not influence therapeutic efficacy of liquid levothyroxine formulation

Morelli, Silvia, Reboldi, Gianpaolo, Moretti, Sonia, Menicali, Elisa, Avenia, Nicola, Puxeddu, Efisio·2016·Endocrine
DOI 10.1007/s12020-015-0788-2
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Abstract

Oral levothyroxine (L-T4) is the mainstay of hypothyroidism treatment. Many factors may influence its absorption, including the timing of administration. Objective of the study is to demonstrate the therapeutic equivalence of administering liquid L-T4 with breakfast or 10 min before breakfast. This was a pilot study conducted with a crossover design AB/BA where A stays for L-T4 with breakfast and B for L-T4 10 min before breakfast. A post hoc analysis was conducted to compare L-T4 administered at breakfast or 10 min before breakfast with L-T4 administered 30 min before breakfast. Sixty-one hypothyroid patients were enrolled and assigned to one of the two treatment sequences. All patients were evaluated for TSH levels at the end of each period. Fifty-nine patients completed the study. The mean thyrotropin concentration was 1.52 ± 0.73 µU/ml when L-T4 was administered with breakfast and 1.46 ± 0.81 µU/ml when it was taken 10 min before breakfast, without clinically and statistically significant differences (P = 0.59), regardless of treatment sequence and period. The mean thyrotropin concentration was 1.54 ± 0.9 µU/ml when L-T4 was administered at 0-10 min intervals before breakfast and 1.25 ± 0.7 µU/ml when it was taken 30 min before breakfast (ratio = 1.23, within our definition of equivalence set at 0.8-1.25). There is therapeutic equivalence between liquid L-T4 administration at breakfast or 10 min before breakfast. We can also hypothesize that there are no clinically relevant differences between liquid L-T4 administration 30 min before breakfast or at shorter intervals.

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Authors
Morelli, S., Reboldi, G., Moretti, S., Menicali, E., Avenia, N., & Puxeddu, E.
Affiliations
University of Perugia (IT)
Corresponding author
Puxeddu, Efisio
ORCID
Venue
Endocrine
Publisher
Springer Science and Business Media LLC
Published
2015-11-04
Volume
52
Issue
3
Pages
571-578
ISSN
  • 0969-711X (ISSN-L)
  • 1355-008X
  • 1559-0100
DOI
10.1007/s12020-015-0788-2
OpenAlex
W2188527353
Cited by
30
References
43
Citations by year
2025: 1 · 2024: 3 · 2023: 2 · 2022: 3 · 2021: 5 · 2020: 1 · 2019: 1 · 2018: 3 · 2017: 1 · 2016: 10
FWCI
4.05
Type
journal article
Language
en
Open access
closed
Licence
www.springer.com/tdm (tdm)
Locations
  • Endocrine (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Thyroid Disorders and Treatments
  • Health Sciences › Medicine › Surgery › Thyroid and Parathyroid Surgery
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Thyroid Cancer Diagnosis and Treatment
Keywords
levothyroxine, liquid formulation, hypothyroidism, timing of drug administration, breakfast, therapeutic equivalence, TSH levels, drug absorption, crossover design
MeSH terms
Adult, Aged, Drug Compounding, Eating, Female, Humans, Hypothyroidism, Male, Middle Aged, Pilot Projects, Solutions, Thyrotropin, Thyroxine, Time Factors, Triiodothyronine, Cross-Over Studies, Hormone Replacement Therapy, Young Adult, Breakfast

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