TY - JOUR
TI - Non-inferiority of liquid thyroxine in comparison to tablets formulation
in the treatment of children with congenital hypothyroidism
AU - Tzifi, Flora
AU - Iliadi, Alexandra
AU - Voutetakis, Antonis
AU - Platis,
AU - Dimitris
AU - Girginoudis, Panagiotis
AU - Kanaka-Gantenbein, Christina
JO - Journal of Pediatric Endocrinology & Metabolism
PY - 2022
VL - 35
TODO - 2
SP - 239-247
PB - Walter de Gruyter GmbH
SN - 0334-018X, 2191-0251
TODO - 10.1515/jpem-2021-0458
TODO - children; congenital hypothyroidism (CH); levothyroxine (LT4); liquid
thyroxine; tablets
TODO - Objectives The aim of the current prospective randomized control study
was to assess efficacy, safety, and non-inferiority of a new liquid
L-thyroxine formulation dissolved in glycerol and water (T4(R) drops,
produced by a Greek pharmaceutical Company, Uni-Pharma, Athens, Greece)
in comparison to the standard Tablets form (T4(R) tablets, Uni-Pharma,
Athens, Greece) in the substitutive treatment of children with
congenital hypothyroidism (CH). Methods Thirty-nine children with CH,
aged 3-12 years old, were enrolled in the study, after parental Informed
Consent has been obtained, while three patients were lost from
follow-up. At baseline, all participants had normal thyroid-stimulating
hormone (TSH) and Free T4 values. Patients were randomly subdivided
according to the assigned treatment in Group A (n=17)-Tablet Form and
Group B (n=19)-Liquid Form. TSH and Free T4 levels were evaluated at 0,
2, 4, and 6 months. Results TSH values showed a statistically
significant difference (p=0.017) between groups only at six months
(Group A having higher TSH levels than Group B, albeit within the normal
range), while Free T4 levels had no statistical difference throughout
the six month study period and were always within the normal range.
Moreover, dose adjustments were more frequent in Group A (p=0.038)
during the six months. Liquid L-thyroxine substitutive treatment
exhibited no statistically significant adverse effects in comparison to
the widely used tablets. Conclusions Levothyroxine (LT4) as liquid
solution formulation is safe and noninferior to the widely used
L-thyroxine Tablets, with less need for dose adjustment, and can
therefore be safely used in the treatment of children with CH.
ER -