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

Endocrine volume 58, pages 143–152 (2017)Cite this article

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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Acknowledgements

This study was supported with unconditional grant by IBSA Farmaceutici Italia s.r.l. The sponsor was not involved in the protocol drafting, data analysis and interpretation of study results.

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Authors and Affiliations

  1. Unit of Clinical Pharmacology, Academic Hospital G. Martino, Messina, Italy

    Rosarita Ferrara, Valentina Ientile, Vincenzo Arcoraci, Carlo Piccinni & Gianluca Trifirò

  2. Department of Clinical and Experimental Medicine, University of Messina, Messina, Italy

    Vincenzo Arcoraci & Salvatore Benvenga

  3. Department of Experimental Medicine, Second University of Naples, Naples, Italy

    Carmen Ferrajolo

  4. Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy

    Carlo Piccinni

  5. Unit of Biostatistics, IRCCS “Casa Sollievo della Sofferenza”, San Giovanni Rotondo (FG), Italy

    Andrea Fontana

  6. Department of Biomedical and Dental Sciences and Morpho-functional Imaging, University of Messina, Messina, Italy

    Gianluca Trifirò

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  1. Rosarita Ferrara
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Correspondence to Gianluca Trifirò.

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The authors declare that they have no competing interests.

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The informed consent was not required as the data utilized were collected retrospectively during routine clinical practice. This study did not involve direct patient contact. All data used was fully anonymised. As a result, the Ethics Committee of the University Hospital of Messina (A.O.U. G. Martino Hospital) does not require ethical approval.

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Ferrara, R., Ientile, V., Arcoraci, V. et al. Treatment pattern and frequency of serum TSH measurement in users of different levothyroxine formulations: a population-based study during the years 2009–2015. Endocrine 58, 143–152 (2017). https://doi.org/10.1007/s12020-017-1242-4

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  • DOI: https://doi.org/10.1007/s12020-017-1242-4

Keywords

  • Levothyroxine
  • Formulations
  • TSH
  • Absorption
  • Switching