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Related Experiment Videos

Clinical experience with Somatonorm.

F Girard, M Gourmelen

    Acta Paediatrica Scandinavica. Supplement
    |January 1, 1986
    PubMed
    Summary
    This summary is machine-generated.

    Somatrem (Somatonorm) demonstrated comparable growth velocities to pituitary human growth hormone (hGH) in patients with hGH deficiency. Complete deficiency showed better response, with no major side effects noted.

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    Area of Science:

    • Endocrinology
    • Pharmacology
    • Pediatrics

    Background:

    • Human growth hormone (hGH) deficiency impacts growth and development.
    • Somatrem is a biosynthetic form of hGH used in treatment.
    • Comparative efficacy and safety data are crucial for therapeutic decisions.

    Purpose of the Study:

    • To compare the efficacy and safety of somatrem (Somatonorm) versus pituitary hGH in patients with hGH deficiency.
    • To evaluate growth response and adverse events in a multicenter trial.
    • To assess antibody formation to hGH and Escherichia coli polypeptide (ECP).

    Main Methods:

    • A double-blind, randomized, comparative multicenter trial involving 21 patients with hGH deficiency.
    • 6-month follow-up due to product withdrawal.

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  • Open study in 14 children treated with Somatonorm for 1 year.
  • Growth velocity, bone age, and antibody levels (anti-hGH, anti-ECP) were monitored.

    • Main Results:

    • Similar growth velocities were observed between somatrem and pituitary hGH.
    • Patients with complete hGH deficiency showed a better response than those with partial deficiency.
    • In the open study, somatrem significantly increased growth velocity (3.26 to 7.1 cm/year) over 1 year.
    • Anti-hGH antibodies developed in 2 patients (comparative trial) and 50% (open study).
    • Anti-ECP antibodies increased in both groups.

    Conclusions:

    • Somatrem is an effective alternative to pituitary hGH for treating hGH deficiency, showing comparable growth promotion.
    • Treatment efficacy is linked to the degree of hGH deficiency.
    • While generally safe, antibody formation to somatrem and ECP should be monitored.