title: Adherence in children with growth hormone deficiency treated with r-hGH and the easypod™ device.
abstract: OBJECTIVE
  Poor adherence to recombinant human growth hormone (r-hGH) therapy is associated with reduced growth velocity in children with growth hormone deficiency (GHD). This twelve-month observational study was to assess adherence in r-hGH patients treated with the easypod™, an electronic, fully automated injection device designed to track the time, date and dose administered.
  
  
  METHODS
  Ninety-seven prepubertal patients receiving r-hGH therapy were included in the study from ten Italian clinical sites and 88 completed the study. To avoid possible confounding effects, only GHD patients (79/88; 89.7 % of the overall study population) were considered in the final analysis. The primary endpoint-adherence to treatment-was calculated as the proportion of injections correctly administered during the observational period out of the expected total number of injections. The relevant information, tracked by the easypod™, was collected at months 6 (V1) and 12 (V2) after baseline (V0). At study termination, adherence data were partially available from 16 patients and fully available from 53 patients. As secondary endpoints, serum IGF-1 levels, fasting serum glucose and insulin levels and key anthropometric characteristics (height, waist circumference and BMI) were also determined.
  
  
  RESULTS
  The easypod™data showed that 56.7 % of the patients were considered to be fully (≥92 %) adherent to their treatment throughout the period V0-V2. Treatment improved stature, significantly increased IGF-1 and produced a non-significant increase in blood glucose and insulin levels.
  
  
  CONCLUSIONS
  The injection-recording system and other characteristics of easypod™could enhance the ability of physicians to monitor adherence to r-hGH treatment.
authors.affiliation: SSD of Pediatric Endocrinology, Pediatric Hospital Microcitemico Antonio Cao AOB Cagliari, Via Edward Jenner, 09121, Cagliari, Italy. Sandro.loche@aob.it.
authors.forename: S
authors.initials: S
authors.lastname: Loche
authors.affiliation: Department of Translational Medical Sciences, University of Naples Federico II, Naples, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Salerno
authors.affiliation: Endocrinology Unit, AOOR Villa Sofia-Cervello, Palermo, Italy.
authors.forename: P
authors.initials: P
authors.lastname: Garofalo
authors.affiliation: Paediatric Division, Hospital F Ferrari, Casarano, Italy.
authors.forename: G M
authors.initials: GM
authors.lastname: Cardinale
authors.affiliation: Department of Pediatrics, AORN Santobono-Pausilipon, Naples, Italy.
authors.forename: M R
authors.initials: MR
authors.lastname: Licenziati
authors.affiliation: Endocrinology Unit, Mother Theresa of Calcutta Territorial Specialist Centre, Potenza, Italy.
authors.forename: G
authors.initials: G
authors.lastname: Citro
authors.affiliation: Paediatric Endocrinology Service, University Hospital of Catania, Catania, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Caruso Nicoletti
authors.affiliation: University-Hospital Department, Bambino Gesù Children's Hospital, IRCCS, Rome, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Cappa
authors.affiliation: Merck KGaA, Darmstadt, Germany.
authors.forename: S
authors.initials: S
authors.lastname: Longobardi
authors.affiliation: Department of Paediatrics, IRCCS Giannina Gaslini Institute, University of Genova, Genoa, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Maghnie
authors.affiliation: Merck Serono S.p.A, Rome, Italy.
authors.forename: R
authors.initials: R
authors.lastname: Perrone
mesh_terms: D001786:Blood Glucose / Q000032:analysis; D002648:Child; D016503:Drug Delivery Systems / Q000295:instrumentation*; D004393:Dwarfism, Pituitary / Q000188:drug therapy*; D004581:Electronics / Q000295:instrumentation*; D005260:Female; D006130:Growth Disorders / Q000188:drug therapy*; D019382:Human Growth Hormone / Q000008:administration & dosage* / Q000172:deficiency*; D006801:Humans; D007334:Insulin-Like Growth Factor I / Q000032:analysis; D008297:Male; D055118:Medication Adherence; D011446:Prospective Studies
chemical_list: D001786:Blood Glucose; D019382:Human Growth Hormone; D007334:Insulin-Like Growth Factor I
keywords: Adherence; Easypod™; Growth disorders (GD); IGF-1