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Schwarz, Hans-Peter; Walczak, Mieczysław; Birkholz-Walerzak, Dorota; Szalecki, Mieczyslaw; Nanu, Michaela; Woehling, Heike and Schuck, Ellen (2016): Two-Year Data from a Long-Term Phase IV Study of Recombinant Human Growth Hormone in Short Children Born Small for Gestational Age. In: Advances in therapy, Vol. 33, No. 3: pp. 423-434

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This ongoing, prospective, open-label, non-comparative, multicenter phase IV study is evaluating the safety and efficacy of recombinant human growth hormone (rhGH;Omnitrope(A (R)), Sandoz GmbH) in short children born small for gestational age (SGA). Here we report data from patients who have completed 2 years' treatment. Eligibility criteria included prepubertal children born SGA with growth disturbances defined as current height standard deviation score (HSDS) <-2.5 and parental adjusted SDS <-1;birth weight and/or length <-2 SDS;and failure of catch-up growth [height velocity (HV) SDS < 0 during the last year] by 4 years of age or later. The primary study objective is to assess the long-term effect of Omnitrope treatment on the development of diabetes in short children born SGA. Secondary objectives include evaluation of efficacy, incidence and severity of adverse events (AEs), occurrence of malignancies during treatment, and detection of anti-rhGH antibodies during treatment. In total, 278 children have been enrolled and received study medication;249 have completed 2 years of treatment. No child has developed diabetes mellitus during the first 2 years;no fasting glucose or 2-h oral glucose tolerance test value exceeded the pre-defined limits of > 126 or > 200 mg/dL, respectively. No adverse alterations in body mass were noted. Treatment-emergent AEs were experienced by 211 (76.2%) children;most of these were of mild-to-moderate intensity (99.3%) and considered unrelated to study medication (97.6%). Treatment with Omnitrope was effective;mean HSDS was -3.39 at baseline, -2.57 at 1 year and -2.15 at 2 years of treatment. Mean HVSDS (peak-centered) also improved, from -2.13 at baseline to +4.16 at 1 year and +2.23 at 2 years. In this second interim analysis, short children born SGA were safely and effectively treated with rhGH (Omnitrope), and 2 years' treatment had no major adverse impact on carbohydrate metabolism or body mass. Sandoz.

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