PMID-18031173 – Sermorelin Review Diagnosis and Treatment GHD

PMID-18031173 – Sermorelin Review Diagnosis and Treatment GHD

Kemp SF, Fielder PJ. Sermorelin: a review of its use in the diagnosis and treatment of children with idiopathic growth hormone deficiency. BioDrugs. 2007;21(6):375-388.

Quick Reference

Property Value
PMID 18031173
Year 2007
Journal BioDrugs
Study Type Systematic Review
Evidence Level I
Sample N/A (review of clinical studies)
Peptide(s) Studied Sermorelin

Key Findings

  • Sermorelin acetate is GHRH(1-29)NH2, identical to the first 29 amino acids of native GHRH(1-44)
  • FDA-approved as Geref for diagnostic testing and treatment of GHD in children (subsequently withdrawn 2008)
  • Subcutaneous sermorelin 30 mcg/kg daily was effective in promoting linear growth in GH-deficient children
  • Growth velocity increased significantly in responders (typically >2 cm/year improvement)
  • Well-tolerated with a favorable safety profile: injection site reactions were most common adverse event
  • Preserves pulsatile GH secretion pattern unlike exogenous GH
  • Acts via GHRH receptor on pituitary somatotrophs to stimulate endogenous GH synthesis and release

Study Design

Comprehensive review of clinical pharmacology, pharmacokinetics, clinical efficacy data, and safety profile of sermorelin in pediatric GH deficiency.

Limitations

  • Focused on pediatric population; adult data limited
  • Geref was withdrawn from market in 2008 (manufacturing issues, not safety)
  • Review of older clinical data (pre-2007)
  • Efficacy data less robust than for recombinant GH

Clinical Relevance

Provides the definitive clinical reference for sermorelin's pharmacology and approved clinical use. Although Geref was withdrawn in 2008, the pharmacological principles remain the foundation for current off-label use of sermorelin in anti-aging and GH optimization. The established safety profile from pediatric use supports the drug's general tolerability.

Related

#research #systematic-review #sermorelin #evidence-level-I