| Title | Efficacy and Safety of Histrelin Subdermal Implant in Children with Central Precocious Puberty: A Multicenter Trial. | | Author(s) | Eugster EA, Clarke W, Kletter GB, Lee PA, Neely EK, Reiter EO, Saenger P, Shulman D, Silverman L, Flood L, Gray W, Tierney D | | Institution | Riley Hospital for Children, Indiana University School of Medicine, Indianapolis, IN; University of Virginia, Charlottesville, VA; Seattle Childrens Hospital and Medical Center, Seattle, WA; Pennsylvania State Children's Hospital, Hershey, PA; Stanford University Medical Center, Stanford, CA; Baystate Children's Hospital, Springfield, MA; Montefiore Medical Center, Bronx, NY; University of South Florida and All Children's Hospital, Petersburg, FL; Goryeb Children's Hospital Atlantic Health System, Morristown, NJ; Valera Pharmaceuticals, Cranbury, NJ. | | Source | J Clin Endocrinol Metab 2007 Feb 27. | | Abstract | Context: Gonadotropin- releasing hormone analog (GnRHa) therapy for central precocious puberty (CPP) typically involves intramuscular injections. The histrelin implant is a new treatment that provides a continuous slow release of the GnRHa histrelin.
Objective: To investigate safety and efficacy of the subdermal histrelin implant for the treatment of CPP in treatment naive and previously treated children.
Design: This was a phase III, open-label prospective study of one year's duration.
Setting: The study was conducted at nine US medical centers.
Patients: Girls 2-8 years (naïve) or 2-10 years (previously treated) and boys 2-9 years (naïve) or 2-11 years (previously treated) with clinical evidence of CPP and a pre-treatment pubertal response to leuprolide stimulation were eligible. Intervention: A 50 mg histrelin implant was inserted subcutaneously in the inner upper arm. Main Outcome Measures: Peak LH after GnRHa stimulation testing, E2 (girls) and testosterone (boys).
Results: Thirty-six subjects (20 naïve) were enrolled. By 1 month, peak LH fell from 28.2 +/- 19.97 mIU/ml (naïve) to 0.8 +/- 0.39 (P < 0.0001), and from 2.1 +/- 2.15 mIU/ml (previously treated) to 0.5 +/- 0.32 (P < 0.0056). E2 suppressed from 24.5 +/- 22.27 pg/ml (naïve) to 5.9 +/- 2.37 pg/ml (p=0.0016) and remained suppressed in previously treated subjects, as did testosterone. Suppression was maintained throughout the study. No significant adverse events occurred.
Conclusions: The subdermal histrelin implant achieves and maintains excellent suppression of peak LH and sex steroid levels for one year in children with CPP. The treatment is well-tolerated. Long-term studies are needed to confirm these results. | | Language | ENG | | Pub Type(s) | JOURNAL ARTICLE
| | PubMed ID | 17327379 |
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