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Background <p>Liquid ethanol-containing levothyroxine (e-LT4) is known to circumvent malabsorption induced by food, drugs, or pathological conditions. Recently a new ethanol-free formulation of liquid levothyroxine (ef-LT4) has been commercialized. No studies have compared e-LT4 with ef-LT4. The aim of the present study is to compare thyroid hormone profile in patients treated with e-LT4 and ef-LT4.</p> Material and methods <p>We retrospectively retrieved thyroid hormonal profile and clinical data of 48 patients diagnosed with hypothyroidism who had been on stable treatment with an e- LT4 formulation at the same dosage for at least one year and who decided to switch to ef-LT4 for tasting issue.</p> Results <p>A significant increase in TSH levels was observed after 6&#xa0;months on ef-LT4 treatment (2.5 ± 0.8 mIU/ml vs. 3.1 ± 1.0 mIU/ml, respectively, <i>p</i> &lt; .001), while fT4 decreased [1.2&#xa0;ng/dl (IQR 1.1–1.4) vs. 1.1&#xa0;ng/dl (1.0–1.2), respectively, <i>p</i> = .047], maintaining the same dosage of LT4. In 31 patients, for whom data were available 12&#xa0;months after the switch, TSH further increased (2.50 ± 0.9 mIU/ml at baseline vs 3.2 ± 0.9 mIU/ml after 6&#xa0;months vs 3.5 ± 0.9 mIU/ml at 12&#xa0;months, <i>p</i> &lt; .001) and fT4 decreased [1.2&#xa0;ng/dl (IQR 1.1–1.4) vs. 1.1&#xa0;ng/dl (IQR 0.9–1.3) vs 1.0&#xa0;ng/dl (IQR 0.9–1.1), <i>p</i> = .008].</p> Conclusion <p>ef-LT4 formulation seems to be less effective compared to e-LT4 over time. However, further prospective cross-sectional studies, performed in large sets of patients, even on concomitant therapy with interfering drugs, are needed.</p>

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Are liquid levothyroxine formulations comparable? The LETI study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年4月24日

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  • Elisa Gatta,
  • Virginia Maltese,
  • Ilenia Pirola,
  • Elena Gandossi,
  • Irene Silvestrini,
  • Massimiliano Ugoccioni,
  • Riccardo Morandi,
  • Claudio Casella,
  • Carlo Cappelli

摘要

Background

Liquid ethanol-containing levothyroxine (e-LT4) is known to circumvent malabsorption induced by food, drugs, or pathological conditions. Recently a new ethanol-free formulation of liquid levothyroxine (ef-LT4) has been commercialized. No studies have compared e-LT4 with ef-LT4. The aim of the present study is to compare thyroid hormone profile in patients treated with e-LT4 and ef-LT4.

Material and methods

We retrospectively retrieved thyroid hormonal profile and clinical data of 48 patients diagnosed with hypothyroidism who had been on stable treatment with an e- LT4 formulation at the same dosage for at least one year and who decided to switch to ef-LT4 for tasting issue.

Results

A significant increase in TSH levels was observed after 6 months on ef-LT4 treatment (2.5 ± 0.8 mIU/ml vs. 3.1 ± 1.0 mIU/ml, respectively, p < .001), while fT4 decreased [1.2 ng/dl (IQR 1.1–1.4) vs. 1.1 ng/dl (1.0–1.2), respectively, p = .047], maintaining the same dosage of LT4. In 31 patients, for whom data were available 12 months after the switch, TSH further increased (2.50 ± 0.9 mIU/ml at baseline vs 3.2 ± 0.9 mIU/ml after 6 months vs 3.5 ± 0.9 mIU/ml at 12 months, p < .001) and fT4 decreased [1.2 ng/dl (IQR 1.1–1.4) vs. 1.1 ng/dl (IQR 0.9–1.3) vs 1.0 ng/dl (IQR 0.9–1.1), p = .008].

Conclusion

ef-LT4 formulation seems to be less effective compared to e-LT4 over time. However, further prospective cross-sectional studies, performed in large sets of patients, even on concomitant therapy with interfering drugs, are needed.