title: A long-acting human growth hormone (Nutropin Depot): efficacy and safety following two years of treatment in children with growth hormone deficiency.
abstract: BACKGROUND
  Nutropin Depots [somatropin (rDNA origin) for injectable suspension] is a long-acting form of human growth hormone (GH) to be administered by subcutaneous (s.c.) injection. The availability of this formulation offers the opportunity for greater convenience and compliance by decreasing the number of injections and frequency of administration required.
  
  
  OBJECTIVE
  To determine the efficacy and safety of a long-acting formulation of GH administered in children with GH deficiency (GHD) once or twice monthly for 2 years.
  
  
  METHODS
  Fifty-six previously untreated, prepubertal children with GHD received Nutropin Depot 1.5 mg/kg once monthly (1x/mo), or 0.75 mg/kg twice monthly (2x/mo) for 24 months. The mean pretreatment growth rate was 5.0 +/- 2.4 cm/yr.
  
  
  RESULTS
  The 0-12 mo growth rate (mean +/- SD) was 8.3 +/- 1.5 cm/yr in the 1x/mo group and 8.2 +/- 2.0 cm/yr in the 2x/mo group. The 12-24 month growth rate was 7.2 +/- 1.5 cm/yr in the 1x/mo group and 6.9 +/- 1.5 cm/yr in the 2x/mo group. During the 24 months of treatment, height standard deviation score (SDS) increased by 1.0 +/- 0.5 SD in the two groups combined (p <0.0001). The corresponding advancement in bone age was 2.2 +/- 0.7 yr, resulting in a gain in Bayley-Pinneau predicted adult height (PAH) SDS of 0.6 +/- 0.9 SD in the 1x/mo group and 0.6 +/- 1.0 SD in the 2x/mo group. No serious adverse events attributable to the study drug were reported. Injection site reactions were common, but resolved without intervention. Pre-dose fasting and postprandial glucose and insulin levels, as well as hemoglobin A1c levels, were unchanged from baseline values.
  
  
  CONCLUSIONS
  Treatment with Nutropin Depot is associated with catch-up growth and normal skeletal maturation and is a viable alternative to daily injections of GH in children with GHD.
authors.affiliation: Department of Pediatrics, Northwestern University, Chicago, IL, USA. bernard.silverman@alkermes.com
authors.forename: Bernard L
authors.initials: BL
authors.lastname: Silverman
authors.forename: Sandra L
authors.initials: SL
authors.lastname: Blethen
authors.forename: Edward O
authors.initials: EO
authors.lastname: Reiter
authors.forename: Kenneth M
authors.initials: KM
authors.lastname: Attie
authors.forename: Rachel B
authors.initials: RB
authors.lastname: Neuwirth
authors.forename: Kathleen M
authors.initials: KM
authors.lastname: Ford
mesh_terms: D001786:Blood Glucose / Q000378:metabolism; D001827:Body Height / Q000187:drug effects; D001846:Bone Development / Q000187:drug effects; D002648:Child; D002675:Child, Preschool; D003692:Delayed-Action Preparations; D005260:Female; D006128:Growth / Q000187:drug effects; D013006:Growth Hormone / Q000009:adverse effects / Q000627:therapeutic use*; D019382:Human Growth Hormone / Q000172:deficiency*; D006801:Humans; D008297:Male; D012727:Sex Characteristics
chemical_list: D001786:Blood Glucose; D003692:Delayed-Action Preparations; D019382:Human Growth Hormone; D013006:Growth Hormone