Endocrine Abstracts

Introduction: PATRO children is an international, non-interventional, longitudinal study of the long-term safety of a biosimilar recombinant human growth hormone (Omnitrope, Sandoz). In particular, the study assesses the diabetogenic potential of Omnitrope and the risk of malignancies. The long-term efficacy is a secondary objective of the study. Here we present safety and efficacy data of UK patients recruited since 2008, following an interim analysis in May 2017.<p class...

Introduction: PATRO Adults is an ongoing, longitudinal, noninterventional study assessing the long-term safety and efficacy of Omnitrope® (Sandoz; recombinant human growth hormone [rhGH]), among adults with severe growth hormone deficiency (GHD) treated in routine clinical practice in European countries. Omnitrope® was approved by the European Medicines Agency (EMA) in 2006, representing the first biosimilar approved by the EMA. We report the la...

Introduction: The ongoing, international, open, longitudinal, non-interventional study, PATRO Adults, aims to determine the long-term safety and efficacy of Omnitrope® (Sandoz), a recombinant human growth hormone (rhGH). Safety data from an interim analysis are presented here.Methods: Eligible patients are male or female adults who are receiving treatment with Omnitrope® and who have provided informed consent. Patients tre...

Introduction: PATRO adults is an international, longitudinal, non-interventional study of the long-term safety and efficacy of recombinant human growth hormone (rhGH; Omnitrope®, Sandoz). The study will provide additional data on the long-term safety of rhGH in adult patients with severe GH deficiency (GHD). Here, we present safety data from an interim analysis.Methods: Eligible patients are adults who are receiving treatment with Omnitro...

Introduction: More data are needed to confirm the long-term safety of recombinant human GH (rhGH) in adult patients with severe GH deficiency (GHD), particularly with regard to diabetogenic potential. PATRO Adults is an ongoing observational, multicentre, open, longitudinal study of Omnitrope, being conducted in hospitals and specialised endocrinology clinics across Europe. Here, we present safety data from an interim analysis.Methods: Eligible patients ...

Introduction: Omnitrope® (Sandoz) is a recombinant human growth hormone (rhGH) and was the first biosimilar medicine approved by the European Medicines Agency. PATRO Adults is an international, longitudinal, non-interventional study of the long-term safety and efficacy of Omnitrope® in adults treated in routine clinical practice. The study provides data on the long-term safety of rhGH in adult patients with severe GH deficiency (GHD). Here we pr...

Introduction: PATRO adults is an ongoing, international, open, longitudinal, non-interventional study of the long-term safety and efficacy of recombinant human GH (rhGH; Omnitrope, Sandoz). The study will provide further data on the long-term safety of rhGH in adult patients with severe GH deficiency (GHD). Here, we present safety data from an interim analysis.Methods: Adults who are receiving treatment with Omnitrope and who have provided informed conse...

Introduction: PATRO adults is an ongoing, international, open, longitudinal, non-interventional study of the long-term safety and efficacy of Omnitrope (Sandoz), a recombinant human GH (rhGH). This study will provide additional data on the long-term safety of rhGH in adult patients with severe GH deficiency (GHD). Here, we present safety data from an interim analysis.Methods: Eligible patients are male or female adults who are receiving treatment with Om...