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Patient outcomes in the GHMonitor: the effect of delivery device on compliance and growth
Paul Desrosiers1, Fanny O'Brien, Sandra Blethen
1Department of Pediatric Endocrinology, Nemours Children's Clinic, Orlando, 32806, and Department of Pediatric Endocrinology, University of Florida, Gainesville, FL, USA. pdesrosiers@nemours.org
Insights
Growth hormone (GH) administration method did not impact patient outcomes over two years. However, the needle-free delivery system (NFDS) showed better compliance, potentially improving outcomes in non-compliant patients.
Area of Science:
- Pediatric Endocrinology
- Pharmacology
- Biotechnology
Background:
- Growth hormone (GH) therapy is crucial for pediatric growth disorders.
- Administration methods, including needle-and-syringe and needle-free devices, may influence treatment adherence and efficacy.
- Saizen GH (somatropin [rDNA origin] for injection) is a commonly used recombinant human growth hormone formulation.
Purpose of the Study:
- To compare the efficacy of two different methods of growth hormone administration on patient outcomes.
- To assess the impact of needle-and-syringe versus needle-free delivery system (NFDS) on growth response in children.
- To evaluate patient compliance with growth hormone therapy based on the administration device used.
Main Methods:
- Analysis of data from 631 North American children in the GHMonitor electronic database.
- Comparison of growth rates, height SD scores, and height age changes over two years between children treated with needle-and-syringe (n=305) and NFDS (n=326).
- Assessment of patient compliance, defined by the number of missed GH doses per month.
Main Results:
- No significant differences in growth response were observed between the needle-and-syringe and NFDS groups over two years.
- A higher proportion of patients using needle-and-syringe missed over half of their prescribed GH doses compared to NFDS users (13.4% vs. 6%, P=.002).
- Poorly compliant patients in both groups exhibited significantly lower growth rates than those with better adherence.
Conclusions:
- The method of GH administration (needle-and-syringe vs. NFDS) did not affect overall treatment outcomes in this cohort.
- The needle-free delivery system (NFDS) was associated with significantly better patient compliance.
- For patients with compliance challenges, utilizing an NFDS may lead to improved growth hormone therapy outcomes.
Abstract:
To determine the effect of method of growth hormone (GH) administration on patient outcomes, we studied data from the GHMonitor, an electronic database registry of North American children treated with Saizen GH (somatropin [rDNA origin] for injection). Data from 631 children, 305 treated with needle and syringe and 326 treated with cool.click needle-free device, were analyzed. The groups were balanced for factors known to affect GH treatment response. There was no difference in response to GH over 2 years of treatment whether assessed by growth rate, change in height SD score, or change in height age. Although the majority of patients were compliant with GH therapy (84.6% of needle-free delivery system [NFDS] and 76.3% of needle and syringe patients missed <3 doses per month), significantly more patients using needle and syringe missed over one-half of their prescribed GH dose (13.4% needle and syringe patients versus 6% of NFDS patients, P=.002). In this group of poorly compliant patients, growth rates were significantly lower than in patients who missed fewer doses. Thus in patients where compliance is an issue, use of the NFDS may result in better outcomes.
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