Revaluation of the clinical and metabolic behavior of GHD children during GH treatment according to newly proposed note 39 of the Italian Medicines Agency (AIFA)

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Background The newly proposed note 39 of the Italian Medicines Agency (AIFA) revisited the diagnostic criteria of growth hormone deficiency (GHD) in children and, applying it, a percentage of children previously diagnosed as GHD may have received a wrong diagnosis and a unnecessary treatment, with potential clinical implications.Aim To evaluate the clinical and metabolic behavior of GH-treated children according to the new criteria of GHD diagnosis.Subjects and Methods: We retrospectively analyzed clinical and metabolic data of 310 prepubertal children (220 M, 90 F, age 10.8 ± 2.9 yrs) with short stature admitted to our section of Endocrinology during the years 2005-2014, having at least a 24 months follow-up. All children were divided, according to new AIFA note 39, into group A (n°181 with a peak of GH < 8 ng/dl after 2 tests), group B (n°103 with a peak of GH ≥ 8 and < 10 ng/dl) and group C (n°26 with a peak of GH > 10 ng/dl). Results At baseline, group A showed higher waist circumference than B (p=0.031) and C (p=0.041), while no difference in metabolic parameters was found between the 3 groups. As expected, group C showed a better height (-1.70 ± 0.35 SD) than A (-2.04 ± 0.72; p=0.002) and B (-2.06 ± 0.86; p=0.010), associated with higher bone/chronological age ratio (p=0.044 and 0.00, respectively) and IGF-1 (p=0.013 and 0.015, respectively). After 12 and 24 months of treatment, group B showed lower height velocity (p<0.001 and 0.049) and QUICKI (both p<0.001) and higher fasting glucose (p=0.001 and 0.015), insulin (p=0.001 and 0.008), Homa-IR (p<0.001 and 0.001) than group A, and HbA1c levels higher at 12 months (p=0.017), although always within the normal range.Conclusions Children considered as affected by GHD on the basis of previous, but not current, AIFA criteria showed a worse auxological and metabolic response, probably confirming that the previous cut-off of 10 ng/dl seems to be too high and those patients may not fully benefit from the GH treatment.
Lingua originaleItalian
Numero di pagine1
Stato di pubblicazionePublished - 2015

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