Results of PIII Supprelin-LA trial published: robust efficacy and safety bodes well fro affirmative nod from FDA in upcoming decision:
J Clin Endocrinol Metab. 2007 Feb 27; [Epub ahead of print] Links
Efficacy and Safety of Histrelin Subdermal Implant in Children with Central Precocious Puberty: A Multicenter Trial.
Eugster EA, Clarke W, Kletter GB, Lee PA, Neely EK, Reiter EO, Saenger P, Shulman D, Silverman L, Flood L, Gray W, Tierney D.
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.
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 (naive) or 2-10 years (previously treated) and boys 2-9 years (naive) 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 naive) were enrolled. By 1 month, peak LH fell from 28.2 +/- 19.97 mIU/ml (naive) 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 (naive) 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.
PMID: 17327379 [PubMed - as supplied by publisher]
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