12/5/2023 0 Comments Sara rosenfeld ne movesCompleted conflict disclosure forms are available through Degnon Associates Inc., the management firm for PES. The PES Board of Directors approved the appointment of each taskforce member following the society's conflict of interest review policy (available from the PES administrative offices) prior to project commencement. The guidelines taskforce was comprised of 7 pediatric endocrinologists from USA and Canada, and a pediatric bioethicist. The definitions have evolved since the original FDA indications, with the most recent iteration provided by the International Classification of Pediatric Endocrine Diagnoses (ICPED). The FDA further stipulated that IGF-I is not indicated to treat secondary IGF-I deficiency resulting from GHD, malnutrition, hypothyroidism or other causes thus, it is not a substitute for GH therapy. The FDA approved IGF-I treatment in 2005 for the long-term treatment of growth failure in pediatric patients with severe PIGFD (defined as both height and serum IGF-I concentration below -3 SD despite normal or elevated GH levels) or with GH gene deletion who developed neutralizing antibodies to GH after a trial of GH therapy. The height cutoff of -2.25 SD (1.2nd percentile) corresponds in adults to 160 cm (63 inches) for men and 150 cm (59 inches) for women. In 1985, GHD became the first indication for recombinant human GH approved by the US Food and Drug Administration (FDA), which it described as “the treatment of pediatric patients who have growth failure due to inadequate secretion of endogenous GH.” In 2003, the FDA expanded GH use to the treatment of ISS, also called non-GH-deficient short stature, defined by height standard deviation score (SDS) ≤-2.25 (≤1.2nd percentile) and associated with growth rates unlikely to permit attainment of adult height (AH) in the normal range, in pediatric patients for whom diagnostic evaluation excludes other causes of short stature that should be observed or treated by other means. In many instances, careful review highlights areas that need further research. Conclusion: The taskforce suggests that the recommendations be applied in clinical practice with consideration of the evolving literature and the risks and benefits to each individual patient. Results: This guideline provides recommendations for the clinical management of children and adolescents with growth failure from GHD, ISS, or PIGFD using the best available evidence. Methods: This guideline was developed following the GRADE approach (Grading of Recommendations, Assessment, Development, and Evaluation). Because idiopathic short stature (ISS) remains a controversial indication, and diagnostic challenges often blur the distinction between ISS, GH deficiency (GHD), and primary IGF-I deficiency (PIGFD), we focused on these three diagnoses, thereby adding recombinant IGF-I therapy to the GH guidelines for the first time. Background/Aims: On behalf of the Drug and Therapeutics, and Ethics Committees of the Pediatric Endocrine Society, we sought to update the guidelines published in 2003 on the use of growth hormone (GH).
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