Results 1 to 10 of about 306 (101)

Safety and Effectiveness of a Biosimilar Recombinant Human Growth Hormone in Children Requiring Growth Hormone Treatment: Analysis of Final Data from PATRO Children, an International, Post-Marketing Surveillance Study [PDF]

Drug Design, Development and Therapy
Sandro Loche,1 Shankar Kanumakala,2 Philippe Backeljauw,3 Karl Otfried Schwab,4 Alfonso M Lechuga-Sancho,5– 7 Altaher Esmael,8 Dragan Urosevic,9 Anca Boldea,8 Markus Zabransky8 1Endocrinologia Pediatra e Centro, Screening Neonatale, Ospedale Pediatrico ...
Loche S, Kanumakala S, Backeljauw P, Schwab KO, Lechuga-Sancho AM, Esmael A, Urosevic D, Boldea A, Zabransky M   +8 more
doaj   +5 more sources

Ten years of clinical experience with biosimilar human growth hormone: a review of safety data [PDF]

Drug Design, Development and Therapy, 2017
Maria Victoria Borrás Pérez,1 Berit Kriström,2 Tomasz Romer,3 Mieczyslaw Walczak,4 Nadja Höbel,5 Markus Zabransky5 1Hospital General de Granollers, Granollers, Barcelona, Spain; 2Department of Clinical Sciences, Pediatrics, Ume ...
Borrás Pérez MV, Kriström B, Romer T, Walczak M, Höbel N, Zabransky M   +5 more
doaj   +5 more sources

Ten years of biosimilar recombinant human growth hormone in Europe [PDF]

Drug Design, Development and Therapy, 2017
Paul Saenger Division of Pediatric Endocrinology, Department of Pediatrics, Winthrop University Hospital, Mineola, NY, USA Abstract: Recombinant human growth hormone (rhGH) has been in clinical use for more than 30 years.
Saenger P
doaj   +6 more sources

Safety and Effectiveness of a Biosimilar Recombinant Growth Hormone in Adults with Growth Hormone Deficiency: Analysis of Final Data from PATRO Adults, an International Post-Marketing Surveillance Study [PDF]

Drug Design, Development and Therapy
Paolo Beck-Peccoz,1 Charlotte Höybye,2 Suat Simsek,3 Günter Stalla,4 Robert  D Murray,5 Altaher Esmael,6 Dragan Urosevic,7 Anca Boldea,6 Markus Zabransky6 1Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Cà Granda Ospedale Maggiore ...
Beck-Peccoz P, Höybye C, Simsek S, Stalla G, Murray RD, Esmael A, Urosevic D, Boldea A, Zabransky M   +8 more
doaj   +5 more sources

Long-term follow up of carbohydrate metabolism and adverse events after termination of Omnitrope® treatment in children born small for gestational age [PDF]

Therapeutic Advances in Endocrinology and Metabolism, 2021
Background: Recombinant human growth hormone (rhGH) therapy can affect carbohydrate metabolism and lead to impaired glucose tolerance during treatment.
Mieczyslaw Walczak, Mieczyslaw Szalecki, Gerd Horneff, Jan Lebl, Barbara Kalina-Faska, Tomasz Giemza, Florentina Moldovanu, Michaela Nanu, Hichem Zouater   +8 more
doaj   +2 more sources

Malignancy risk in adults with growth hormone deficiency undergoing long-term treatment with biosimilar somatropin (Omnitrope): data from the PATRO Adults study [PDF]

Therapeutic Advances in Endocrinology and Metabolism, 2020
Background: To assess the safety (particularly the occurrence of malignancies) of growth hormone (GH) replacement (Omnitrope ® ) in adults with GH deficiency, using data from the ongoing PATRO Adults post-marketing surveillance study.
Paolo Beck-Peccoz, Charlotte Höybye, Robert D Murray, Suat Simsek, Markus Zabransky, Hichem Zouater, Günter Stalla   +6 more
doaj   +2 more sources

Long-term safety and efficacy of Omnitrope®, a somatropin biosimilar, in children requiring growth hormone treatment: Italian interim analysis of the PATRO Children study. [PDF]

Ital J Pediatr, 2016
Background: PATRO Children is an ongoing observational, longitudinal, non-interventional, global post-marketing surveillance study, which is investigating the long-term safety and effectiveness of Omnitrope\uae, a somatropin biosimilar to Genotropin\uae,
Iughetti L, Tornese G, Street ME, Napoli F, Giavoli C, Antoniazzi F, Stagi S, Luongo C, Azzolini S, Ragusa L, Bona G, Zecchino C, Aversa T, Persani L, Guazzarotti L, Zecchi E, Pietropoli A, Zucchini S.   +17 more
europepmc   +6 more sources

No increased risk of glucose metabolism disorders in adults with growth hormone deficiency undergoing long-term treatment with biosimilar somatropin (Omnitrope®): data from an observational, longitudinal study [PDF]

BMC Endocrine Disorders, 2019
Background To evaluate the impact of treatment with recombinant human growth hormone (rhGH; Omnitrope®) on the risk of diabetes mellitus in adults with growth hormone deficiency (GHD), using data from the ongoing PATRO Adults post-marketing surveillance ...
Paolo Beck-Peccoz, Charlotte Höybye, Robert D. Murray, Suat Simsek, Markus Zabransky, Hichem Zouater, Günter Stalla   +6 more
doaj   +2 more sources

Design of, and first data from, PATRO Children, a multicentre, noninterventional study of the long-term efficacy and safety of Omnitrope in children requiring growth hormone treatment [PDF]

Therapeutic Advances in Endocrinology and Metabolism, 2013
Objective: To describe the rationale, design and first data from PATRO Children, a postmarketing surveillance of the long-term efficacy and safety of somatropin (Omnitrope ® ) for the treatment of children requiring growth hormone treatment.
Roland Pfäffle, Karl Otfried Schwab, Otilia Marginean, Mieczyslaw Walczak, Mieczyslaw Szalecki, Ellen Schuck, Markus Zabransky, Stefano Zucchini   +7 more
doaj   +2 more sources

Patients’ perceptions on the usability of the SurePal™ self-injection device for Omnitrope: a questionnaire-based observational study conducted in paediatric patients in France [PDF]

Therapeutic Advances in Endocrinology and Metabolism, 2017
Background: A questionnaire-based survey was conducted to evaluate attitudes towards a reusable self-injection system, SurePal™, among paediatric patients with growth disturbances who were prescribed treatment with somatropin (Omnitrope ® ) as part of ...
Régis Coutant, Clémentine Dupuis, Patricia Pigeon, Phillipe Rebaud   +3 more
doaj   +2 more sources