Published in:
Open Access
01-12-2014 | Original Research
Switching to Omnitrope® from Other Recombinant Human Growth Hormone Therapies: A Retrospective Study in an Integrated Healthcare System
Authors:
Nazia Rashid, Paul Saenger, Yi-Lin Wu, Heike Woehling, Matthew Frankel, Fima Lifshitz, Michael Muenzberg, Robert Rapaport
Published in:
Biologics in Therapy
|
Issue 1-2/2014
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Abstract
Introduction
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.