Cited by 23Thyroid Disorders and TreatmentsThyroid and Parathyroid SurgeryThyroid Cancer Diagnosis and Treatment

Treatment pattern and frequency of serum TSH measurement in users of different levothyroxine formulations: a population-based study during the years 2009-2015

Ferrara, Rosarita, Ientile, Valentina, Arcoraci, Vincenzo, Ferrajolo, Carmen, Piccinni, Carlo, Fontana, Andrea, Benvenga, Salvatore, Trifirò, Gianluca·2017·Endocrine

Abstract

Background Several conditions can modify the intestinal absorption of levothyroxine tablets, with potential consequences on their therapeutic effect. Pre-dosed ampoules and oral drops have been recently made available to overcome this limitation.Aims To describe the pattern of use of different formulations of levothyroxine in a general population of Southern Italy and to perform an exploratory analysis investigating the effect of switching from levothyroxine tablets to oral liquid formulations.Methods Data were extracted from the Caserta Local Health Unit database. All patients receiving at least one levothyroxine prescription during the years 2009-2015 were identified. 1-year incidence of use of formulation-specific levothyroxine was calculated. Switchers between levothyroxine tablets and oral liquid formulations were identified and the frequency of thyroid-stimulating hormone measurement within 2 years prior and after the switch date was explored.Results Overall, 56,354 levothyroxine users were included in the study. Of these, 55,147 patients received at least one prescription for tablets (97.9%), 1867 pre-dosed ampoules (3.3%) and 1550 oral drops (2.8%). The proportion of levothyroxine users receiving oral liquid formulations slightly increased over time. Patients switching from tablets to oral liquid formulations showed a statistically significant reduction in the number of thyroid-stimulating hormone measurements after switching from tablets, especially in presence of drugs interacting with levothyroxine potentially altering its absorption.Conclusions Use of levothyroxine oral liquid formulations is increasing over time even though their use is still limited in a general population of Southern Italy. Our exploratory analysis showed that the frequency of thyroid-stimulating hormone measurement was reduced in patients switching from levothyroxine tablet to new formulations.

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Crossref · 10.1007/s12020-017-1242-4

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  • A cross-sectional study in 2017 involving more than 56,000 patients in Italy showed that more than 5% of LT4-treated patients have taken liquid formulations.

    “A cross-sectional study in 2017 involving more than 56 000 patients in Italy showed that more than 5% of LT4-treated patients have taken liquid formulations (182).”
  • The proportion of patients taking liquid solutions is presumed to be lower in other European countries and North America than in Italy.

    “Considering that it was first introduced to the Italian market, the proportion of patients taking liquid solutions is presumed to be lower in other European countries and North America.”
  • A real-world study showed significantly reduced TSH levels after the switch from a tablet to a liquid preparation.

    “The real-world study also showed significantly reduced TSH levels after the switch from a tablet to a liquid preparation (182).”
  • Taken together, liquid solutions have higher absorption, faster Tmax, and lower and more stable TSH levels than solid formulations, partially due to better intestinal absorption.

    “Taken together, these results show that liquid solutions have higher absorption, faster Tmax, and lower and more stable TSH levels than solid formulations, partially due to better intestinal absorption.”
  • Orally administered liquid and soft-gel LT4 formulations are associated with higher serum FT4 levels and lower TSH levels than tablet formulations, even when the overall LT4 dose level is the same.

    “Other reports from both retrospective and prospective observational studies indicate that orally administered liquid and soft-gel formulations of LT4 are associated with higher serum FT4 levels and lower TSH levels than tablet formulations, even when the overall LT4 dose level is the same – perhaps due to the absence of gastric disintegration [ 38 – 44 ].”

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Authors
Ferrara, R., Ientile, V., Arcoraci, V., Ferrajolo, C., Piccinni, C., Fontana, A., Benvenga, S., & Trifirò, G.
Affiliations
  • University of Messina (IT)
  • University of Campania "Luigi Vanvitelli" (IT)
  • Casa Sollievo della Sofferenza (IT)
Corresponding author
Trifirò, Gianluca
Venue
Endocrine
Published
2017-02-02
Volume
58
Issue
1
Pages
143-152
ISSN
  • 0969-711X (ISSN-L)
  • 1355-008X
  • 1559-0100
OpenAlex
W2584191594
Cited by
23
References
38
Citations by year
2026: 1 · 2023: 3 · 2022: 3 · 2021: 5 · 2020: 4 · 2019: 2 · 2018: 4 · 2017: 1
FWCI
2.38
Type
journal article
Language
en
Open access
closed
Locations
  • Endocrine (publishedVersion)
  • PubMed (publishedVersion)
  • Archivio Istituzionale della Ricerca - Università degli Studi della Campania "Luigi Vanvitelli" (submittedVersion)
Funders
IBSA Farmaceutici Italia s.r.l.
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, oral liquid formulation, treatment patterns, hypothyroidism, Southern Italy
MeSH terms
Adolescent, Adult, Age Factors, Aged, Aged, 80 and over, Drug Compounding, Female, Humans, Hypothyroidism, Italy, Longitudinal Studies, Male, Middle Aged, Tablets, Thyrotropin, Thyroxine, Incidence, Prevalence, Pharmaceutical Solutions, Hormone Replacement Therapy, Young Adult

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