Cited by 57Thyroid Disorders and TreatmentsThyroid and Parathyroid SurgeryThyroid Cancer Diagnosis and Treatment

Shift from levothyroxine tablets to liquid formulation at breakfast improves quality of life of hypothyroid patients

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Guglielmi, Rinaldo, Grimaldi, Franco, Negro, Roberto, Frasoldati, Andrea, Misischi, Irene, Graziano, Filomena, Cipri, Claudia, Guastamacchia, Edoardo +2 more·2018·Endocrine, Metabolic & Immune Disorders - Drug Targets

Abstract

BACKGROUND: Until recently, treatment of hypothyroidism has been accomplished using monotherapy of synthetic L-thyroxine (L-T4) sodium tablets that should be taken 30-60 minutes before breakfast. Nowadays, a liquid preparation of levothyroxine is available and can effectively replace tablets without the need of waiting before having breakfast. Evidence of Quality of life (QoL) improvement when shifting from the former to the latter preparation, however, is still lacking. OBJECTIVE: The study aimed to assess changes in QoL of hypothyroid patients dissatisfied with their therapy with L-T4 sodium tablets who were switched from tablets taken 30-60 minutes before breakfast to liquid L-T4 at breakfast. METHODS: A total of 418 consecutive hypothyroid subjects treated by means of L-T4 tablets were asked about their satisfaction/dissatisfaction in order to take the medication 30-60 minutes before having breakfast. Overall, 110 patients (26.3%) complained of the timing of their L-T4 therapy (30-60 minutes before breakfast). A dedicated QoL questionnaire (ThyTSQ), taking just a few minutes to be filled in was then administered to these dissatisfied patients. They were therefore switched to L-T4 to be taken at breakfast. Aiming to avoid TSH elevation due to L-T4 tablets malabsorption caused by meal interference and gastric pH changes, patients were invited to take L-T4 liquid form, as this is claimed to be scarcely affected by the non-fasting state. The questionnaire (ThyTSQ) was administered again at the control visit 3 months later. TSH, FT4, FT3 serum concentrations and metabolic parameters were also recorded. RESULTS: An improved QoL, mainly due to an easier adherence to treatment, was reported by 66.6% of 102 patients who completed the study after shifting from taking medication 30-60 minutes before breakfast to at breakfast ingestion (P<0.01). An overall 10.7% of patients found the liquid formulation distasteful. Mean values of TSH, FT4, FT3, and of metabolic parameters did not significantly change but in eight patients (7.7%) who showed a TSH increase > 2mIU/L. CONCLUSION: In hypothyroid subjects dissatisfied with L-T4 tablets ingested 30-60 minutes before breakfast, the shift to the same dose of L-T4 in liquid form taken at breakfast improved QoL in the majority of patients, without affecting thyroid function.

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  • Taken together, the convenience of the liquid preparation improves patient compliance.

    “Taken together, these data show that the convenience of the liquid preparation improves patient compliance.”
  • Approximately 10% of patients declared that the solution was distasteful and then returned to the solid LT4 formulation.

    “Approximately 10% of patients declared that the solution was distasteful and then returned to the solid LT4 formulation (212).”
  • A switch from 30 to 60 minutes before breakfast to the same dose of LT4 in the liquid form taken at breakfast could improve the quality of life in the majority of patients.

    “In addition, a switch from 30 to 60 minutes before breakfast to the same dose of LT4 in the liquid form taken at breakfast could improve the quality of life in the majority of patients (212).”
  • Taking a liquid LT4 formulation with breakfast, rather than LT4 tablets on an empty stomach before breakfast, was associated with greater patient satisfaction, as judged by significant improvements in three of seven subscores in the Underactive Thyroid Treatment Satisfaction Questionnaire.

    “Guglielmi et al. open-label longitudinal study found that taking a liquid LT4 formulation with breakfast (rather than taking LT4 tablets on an empty stomach before breakfast) was associated with greater patient satisfaction, as judged by significant ( p < 0.01) improvements in three of the seven subscores in the Underactive Thyroid Treatment Satisfaction Questionnaire [ 26 ].”

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References 37 · Cited by 57

Research works printed but not linked: 2

  1. [23]Ladenson P.W. Psychological well-being in patients. Clin. Endocrinol. (Oxf.) 2002 57 575 576 12390329
  2. [32]Cappelli C. Pirola I. Gandossi E. Formenti A. Castellano M. Oralliquidlevothyroxine treatment at breakfast: a mistake? Eur. J. Endocrinol. 2013 170 95 99 24123095

Authors
Guglielmi, R., Grimaldi, F., Negro, R., Frasoldati, A., Misischi, I., Graziano, F., Cipri, C., Guastamacchia, E., Triggiani, V., & Papini, E.
Affiliations
  • Ospedale Regina Apostolorum (IT)
  • Endocrinology and Metabolic Disease Unit, Azienda Ospedaliero-Universitaria "S. Maria della Misericordia", Udine, Italy
  • Ospedale Vito Fazzi (IT)
  • Santa Maria Nuova Hospital (IT)
  • University of Bari Aldo Moro (IT)
Corresponding author
Triggiani, Vincenzo
Venue
Endocrine, Metabolic & Immune Disorders - Drug Targets
Published
2018-04-02
Volume
18
Issue
3
Pages
235-240
ISSN
1871-5303 (ISSN-L)
OpenAlex
W2785256773
Cited by
57
References
37
Citations by year
2026: 2 · 2025: 6 · 2024: 12 · 2023: 8 · 2022: 10 · 2021: 9 · 2020: 6 · 2019: 3 · 2018: 1
FWCI
3.78
Type
journal article
Language
en
Open access
Licence
cc-by-nc
Locations
  • Endocrine Metabolic & Immune Disorders - Drug Targets (publishedVersion)
  • Europe PMC (PubMed Central) (publishedVersion, cc-by-nc)
  • PubMed Central (publishedVersion, cc-by-nc)
  • PubMed (publishedVersion)
  • CINECA IRIS Institutional Research Information System (University of Bari Aldo Moro) (submittedVersion)
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
hypothyroidism, levothyroxine, liquid formulation, tablet formulation, timing of drug administration, quality of life, medication adherence, thyroid-stimulating hormone, free thyroxine, free triiodothyronine, patient satisfaction, malabsorption, gastric pH, metabolic parameters, dose adjustment
MeSH terms
Adult, Drug Compounding, Female, Humans, Hypothyroidism, Male, Middle Aged, Quality of Life, Surveys and Questionnaires, Tablets, Thyroxine, Hormone Replacement Therapy, Drug Substitution, Breakfast

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