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Aim <p>This study compares the efficacy and safety of three levothyroxine (LT4) formulations in pediatric patients with congenital hypothyroidism (CH).</p> Methods <p>This is a retrospective-prospective observational monocentric study conducted at the Pediatric Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Italy. Patients’ data were collected from diagnostic confirmation following CH positivity on newborn screening (occurring between January 2019 and April 2024) through age 3 years. According to the LT4 pharmaceutical formulation used in routine clinical practice, patients were assigned to one of three specific groups: T (tablets), D (oral drops), or S (oral solution).</p> Results <p>82 patients were enrolled (group D, <i>N</i> = 30; group S, <i>N</i> = 25; group T, <i>N</i> = 27). At 7–15 days of follow-up, the median TSH concentration was significantly higher in group S compared with group T (<i>p</i> = 0.020). Accordingly, the proportion of patients with serum TSH concentrations above the reference range was significantly higher in group S compared with group T at this time point (<i>p</i> = 0.005). Another difference was observed at 12 months of follow-up, when the proportion of patients with serum fT4 concentrations below the reference range was higher in group D than in groups S and T (<i>p</i> = 0.011). No treatment-related adverse effects were observed with any formulation.</p> Conclusion <p>The three LT4 formulations were equally effective in normalizing and maintaining serum TSH and fT4 within reference ranges. However, the clinical relevance of the differences observed at specific time points requires further investigation.</p>

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Comparison between liquid and tablet formulations in the treatment of congenital hypothyroidism

  • 期刊论文

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  • 发表日期：

    2026年5月28日

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  • Anna Parzianello,
  • Erika Cantarelli,
  • Elisa Bortolamedi,
  • Egidio Candela,
  • Alessandra Cassio,
  • Federico Baronio,
  • Marcello Lanari,
  • Rita Ortolano

摘要

Aim

This study compares the efficacy and safety of three levothyroxine (LT4) formulations in pediatric patients with congenital hypothyroidism (CH).

Methods

This is a retrospective-prospective observational monocentric study conducted at the Pediatric Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Italy. Patients’ data were collected from diagnostic confirmation following CH positivity on newborn screening (occurring between January 2019 and April 2024) through age 3 years. According to the LT4 pharmaceutical formulation used in routine clinical practice, patients were assigned to one of three specific groups: T (tablets), D (oral drops), or S (oral solution).

Results

82 patients were enrolled (group D, N = 30; group S, N = 25; group T, N = 27). At 7–15 days of follow-up, the median TSH concentration was significantly higher in group S compared with group T (p = 0.020). Accordingly, the proportion of patients with serum TSH concentrations above the reference range was significantly higher in group S compared with group T at this time point (p = 0.005). Another difference was observed at 12 months of follow-up, when the proportion of patients with serum fT4 concentrations below the reference range was higher in group D than in groups S and T (p = 0.011). No treatment-related adverse effects were observed with any formulation.

Conclusion

The three LT4 formulations were equally effective in normalizing and maintaining serum TSH and fT4 within reference ranges. However, the clinical relevance of the differences observed at specific time points requires further investigation.