Treatment pattern and frequency of serum TSH measurement in users of different levothyroxine formulations: a population-based study during the years 2009-2015
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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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).”
From Levothyroxine: conventional and novel drug delivery formulations. (2023) · cites this paper as [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.”
From Levothyroxine: conventional and novel drug delivery formulations. (2023) · cites this paper as [182]
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).”
From Levothyroxine: conventional and novel drug delivery formulations. (2023) · cites this paper as [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.”
From Levothyroxine: conventional and novel drug delivery formulations. (2023) · cites this paper as [182]
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 ].”
From Factors influencing the levothyroxine dose in the hormone replacement therapy of primary hypothyroidism in adults (2022) · cites this paper as [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
- ORCID
- 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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