ESPE Abstracts (2016) 86 P-P2-681

Evaluation of GH Deficient Pre Pubertal Children Treated with Omnitrope® Using the AuxoLog Computer Program

Maria Ruiz del Campoa, Jose Revorio Gonzaleza, Alfonso Lechugab, Ana Lucia Gomez Gilac, Monica Fernandez Canciod, Antonio Carrascosae & Margarida Palla Garciaf

aHospital San Pedro, Logroño, Spain; bHospital Universitario Puerta del Mar, Cádiz, Spain; cHospital Universitario Virgen del Rocío, Sevilla, Spain; dLaboratorio Endocrinología Pediátrica, CIBER Enfermedades Raras, Hospital Vall d’Hebron, Barcelona, Spain; eHospital Universitario Vall d’Hebron, Barcelona, Spain; fSandoz Farmacéutica, Madrid, Spain

Background: AuxoLog is a validated computer program that evaluates auxologic parameters comparing them with the Spanish growth charts. It also allocates subjects to the corresponding pubertal development group.

Objective: To assess the evolution of auxological parameters in GH deficient (GHD) pre pubertal children treated with Omnitrope for a minimum of 2 years prior to puberty.

Method: This study is non-interventional, retrospective, longitudinal, multicentre study. Patient data was collected from the medical histories of patients and registered in the AuxoLog program.

Results: Sixteen patients were recruited, with a mean age of 13.2 years. 56.3% (9) were males. The mean age at the beginning of treatment with Omnitrope® was 9.1±0.98 years (9.35±1.08 in males and 8.78±0.8 in females). The HSDS at the beginning of treatment was −2.87±0.4. After the first and second years of treatment the HSDS was −2.08±0.44 and −1.76±0.47 respectively, corresponding to an increase in HSDS of 0.79±0.4 in the first year and 0.32±0.4 in the second year. The Increase in HSDS in the first 2 years of treatment was 1.11±0.4. A similar evolution was observed with height velocity SDS (HVSDS): 4.91±2.17 and 2.07±1.58 at the first and second years of treatment respectively. Similar results were obtained in previous studies concerning the Spanish population. Eleven adverse events were reported, all non-serious and mild to moderate; two possibly related to treatment (headache, lumbar pain).

Conclusion: Omnitrope® showed efficacy and safety in the treatment of pre pubertal children diagnosed GHD.

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