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[Differences in the effectiveness of levothyroxine preparations].

K W Wenzel1, U Mehrländer

  • 1Klinikum Charlottenburg, Freie Universität, Berlin.

Deutsche Medizinische Wochenschrift (1946)
|January 15, 1987
PubMed
Summary

Bioequivalence of L-thyroxine preparations varied significantly. Preparation C showed markedly reduced bioavailability, with higher TSH levels compared to Preparation A. Preparation B also resulted in higher TSH levels than Preparation A.

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Area of Science:

  • Endocrinology
  • Pharmacokinetics
  • Thyroid Hormone Replacement Therapy

Background:

  • L-thyroxine is a common treatment for hypothyroidism.
  • Bioequivalence of different L-thyroxine preparations is crucial for therapeutic efficacy.
  • Variations in bioavailability can impact patient outcomes.

Purpose of the Study:

  • To compare the bioequivalence of three proprietary L-thyroxine preparations.
  • To assess the impact of different preparations on thyroid-stimulating hormone (TSH) and thyroxine levels.
  • To identify potential differences in effectiveness and bioavailability.

Main Methods:

  • A cross-over trial design was employed.
  • Three proprietary L-thyroxine preparations (A, B, and C) were administered.

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  • Serum concentrations of basal and thyrotropin-releasing hormone (TRH)-stimulated TSH, total thyroxine (T4), and free thyroxine (fT4) were measured.

    • Main Results:

    • Preparation B (Euthyrox) showed significantly higher basal and TRH-stimulated TSH levels compared to Preparation A (L-Thyroxin Henning).
    • Preparation C (Levothyroxine, enos) resulted in significantly lower T4 and fT4 levels and significantly higher basal and TRH-stimulated TSH levels compared to Preparation A.
    • While Preparation B showed a tendency towards inferiority, Preparation A's greater effectiveness was not statistically proven across all data. Preparation C demonstrated markedly reduced bioavailability.

    Conclusions:

    • Significant differences in bioequivalence exist among L-thyroxine preparations.
    • Preparation C exhibits notably reduced bioavailability and effectiveness.
    • Clinical monitoring of thyroid function is essential when switching between L-thyroxine formulations.