title: Switching to Omnitrope(®) from Other Recombinant Human Growth Hormone Therapies: A Retrospective Study in an Integrated Healthcare System.
abstract: BACKGROUND
  This study was conducted using an integrated retrospective database to evaluate the effectiveness of Omnitrope(®) (Sandoz) on children with growth hormone deficiency (GHD), idiopathic short stature (ISS), and Turner Syndrome (TS) who switched from a non-Omnitrope recombinant human growth hormone (rhGH) preparation during routine clinical care.
  
  
  METHODS
  This was a retrospective study which identified patients with GHD, ISS, and TS during the study time period of January 1, 2006 and July 31, 2011. Patients were included if they switched to Omnitrope from another non-Omnitrope rhGH therapy during the study time period, were <18 years of age at time of switch, and on a prior rhGH therapy for at least 15 months pre-switch and on Omnitrope for 15 months post-switch. Auxological parameters (height, height standard deviation score [HSDS], height velocity [HV], and height velocity standard deviation score [HVSDS]) were evaluated during post-switch.
  
  
  RESULTS
  One hundred and three patients were identified: GHD (n = 57), ISS (n = 26), and TS (n = 20). There was continuous growth in height for all 103 patients with an average rate of 6.52 cm over the 15-month post-switch period. Patients with GHD grew an average rate of 6.30 cm, patients with ISS grew an average rate of 6.58 cm, and patients with TS grew an average rate of 6.52 cm over the 15-month post-switch period. The average rate of HSDS was increased by 0.04 for all patients. The HV and HVSDS demonstrated the expected decline with advancing age and prolonged duration of treatment.
  
  
  CONCLUSIONS
  The growth trajectories of rhGH-treated patients were not negatively impacted by switching to Omnitrope and growth rates remained as expected prior to the switch.
authors.affiliation: Kaiser Permanente, Southern California Region, Drug Information Services, Downey, CA, USA. Nazia.X.Rashid@kp.org.
authors.forename: Nazia
authors.initials: N
authors.lastname: Rashid
authors.affiliation: Department of Pediatrics, Albert Einstein College of Medicine, New York, NY, USA.
authors.forename: Paul
authors.initials: P
authors.lastname: Saenger
authors.affiliation: Department of Research and Evaluation, Kaiser Permanente, Pasadena, CA, USA.
authors.forename: Yi-Lin
authors.initials: YL
authors.lastname: Wu
authors.affiliation: Sandoz International GmbH, Holzkirchen, Germany.
authors.forename: Heike
authors.initials: H
authors.lastname: Woehling
authors.affiliation: Sandoz Inc., Princeton, NJ, USA.
authors.forename: Matthew
authors.initials: M
authors.lastname: Frankel
authors.affiliation: Pediatric Sunshine Academics, Santa Barbara, CA, USA.
authors.forename: Fima
authors.initials: F
authors.lastname: Lifshitz
authors.affiliation: Sandoz International GmbH, Holzkirchen, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Muenzberg
authors.affiliation: Department of Pediatrics, Mount Sinai College of Medicine, New York, NY, USA.
authors.forename: Robert
authors.initials: R
authors.lastname: Rapaport
keywords: Biologics; Children; Growth hormone deficiency (GHD); Idiopathic short stature Omnitrope®; Recombinant human growth hormone (rhGH); Switching; Turner syndrome
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