Efficacy and Safety of Once-Weekly Somatrogon Compared With Once-Daily Somatropin (Genotropin ®) in Japanese Children With Pediatric Growth Hormone Deficiency: Results From a Randomized Phase 3 Study
The objective of this Phase 3 study (NCT03874013) was to compare the efficacy and safety of once-weekly somatrogon with once-daily Genotropin in Japanese children with GHD.
Methods
In this open-label, randomized, active-controlled study, 44 prepubertal Japanese children with GHD (boys: 3 to (Source: Hormone Research in Paediatrics)
Source: Hormone Research in Paediatrics - April 13, 2022 Category: Endocrinology Source Type: research
Efficacy and safety of weekly somatrogon vs daily somatropin in children with growth hormone deficiency: a phase 3 study
CONCLUSIONS: The efficacy of once-weekly somatrogon was non-inferior to once-daily somatropin, with similar safety and tolerability profiles.PMID:35405011 | DOI:10.1210/clinem/dgac220 (Source: The Journal of Clinical Endocrinology and Metabolism)
Source: The Journal of Clinical Endocrinology and Metabolism - April 11, 2022 Category: Endocrinology Authors: Cheri Deal Joel Steelman Elpis Vlachopapadopoulou Renata Stawerska Lawrence A Silverman Moshe Phillip Ho-Seong Kim Cheol Woo Ko Oleg Malievskiy Jose F Cara Carl L Roland Carrie Turich Taylor Srinivas Rao Valluri Michael P Wajnrajch Aleksandra Pastrak Brad Source Type: research
Long-term safety of growth hormone in adults with growth hormone deficiency: Overview of 15,809 GH-treated patients
CONCLUSIONS: These final KIMS cohort data support the safety of long-term GH replacement in adults with GHD as prescribed in routine clinical practice.PMID:35368070 | DOI:10.1210/clinem/dgac199 (Source: The Journal of Clinical Endocrinology and Metabolism)
Source: The Journal of Clinical Endocrinology and Metabolism - April 3, 2022 Category: Endocrinology Authors: Gudmundur Johannsson Philippe Touraine Ulla Feldt-Rasmussen Antonio Pico Greisa Vila Anders F Mattsson Martin Carlsson M árta Korbonits Andr é P van Beek Michael P Wajnrajch Roy Gomez Kevin C J Yuen Source Type: research
Long-term safety of growth hormone in adults with growth hormone deficiency: Overview of 15,809 GH-treated patients
CONCLUSIONS: These final KIMS cohort data support the safety of long-term GH replacement in adults with GHD as prescribed in routine clinical practice.PMID:35368070 | DOI:10.1210/clinem/dgac199 (Source: The Journal of Clinical Endocrinology and Metabolism)
Source: The Journal of Clinical Endocrinology and Metabolism - April 3, 2022 Category: Endocrinology Authors: Gudmundur Johannsson Philippe Touraine Ulla Feldt-Rasmussen Antonio Pico Greisa Vila Anders F Mattsson Martin Carlsson M árta Korbonits Andr é P van Beek Michael P Wajnrajch Roy Gomez Kevin C J Yuen Source Type: research
Somatropin
(Source: Reactions Weekly)
Source: Reactions Weekly - April 1, 2022 Category: Drugs & Pharmacology Source Type: research
Growth hormone isoform testing in capillary dried blood spots: Results from single and multiple dose administration studies and large ‐scale field collections
Human growth hormone was administered to volunteers as either a single dose or multiple doses. Capillary blood was collected from all volunteers using the Tasso M20 device and tested using the GH Isoforms test. Growth hormone was detectable in capillary blood for up to 24 h following use. AbstractA multiphase study was designed to examine the detectability of human growth hormone (GH) use in capillary dried blood spots (DBS). First, 13 subjects self-injected a single, 2-mg dose of somatropin and collected capillary DBS samples for 24 h. Next, nine subjects self-injected 2-mg somatropin, six times over the course of 1...
Source: Drug Testing and Analysis - March 11, 2022 Category: Drugs & Pharmacology Authors: Geoffrey D. Miller,
Jacob Husk,
Andre K. Crouch,
Daniel Eichner Tags: SPECIAL ISSUE ‐ RESEARCH ARTICLE Source Type: research
Safety and effectiveness of Omnitrope ® (somatropin) in PATRO Children: a multi-center, post-marketing surveillance study comparison of US and international cohort data
Conclusion: Omnitrope ® treatment appears to be well tolerated and effective in US patients and those from other countries. Across the pediatric indications included, there was no evidence of an increased risk of developing uncommon or unexpected AEs with rhGH.Trial registration: NA.What is Known:• Continued monitoring of patients treated with recombinant human growth hormone (rhGH) is important, particularly in terms of diabetogenic potential and the risk of malignancies.• The PAtients TReated with Omnitrope® (PATRO) Children study is a long-term, post-marketing surveillance program for the rhGH Omnitrope®.What is ...
Source: European Journal of Pediatrics - March 11, 2022 Category: Pediatrics Source Type: research
Switching to Weekly Lonapegsomatropin from Daily Somatropin in Children with Growth Hormone Deficiency: The fliGHt Trial
Conclusions. Lonapegsomatropin treatment outcomes were as expected across a range of ages and treatment experiences. Switching to lonapegsomatropin resulted in a similar AE profile to daily somatropin therapy. (Source: Hormone Research in Paediatrics)
Source: Hormone Research in Paediatrics - March 9, 2022 Category: Endocrinology Source Type: research
Growth hormone isoform testing in capillary dried blood spots: results from single and multiple dose administration studies and large ‐scale field collections
AbstractA multi-phase study was designed to examine the detectability of human growth hormone (GH) use in capillary dried blood spots (DBS). First, thirteen subjects self-injected a single, 2mg dose of somatropin and collected capillary DBS samples for 24 hours. Next, nine subjects self-injected 2mg somatropin, six times over the course of eleven days; DBS were collected intermittently following dosing. Finally, a non-drug, large-scale field study involved DBS collections from an athlete and staff population over three years. All DBS samples were self-collected using the Tasso M20 device and were analyzed for the presence ...
Source: Drug Testing and Analysis - March 6, 2022 Category: Drugs & Pharmacology Authors: Geoffrey D. Miller,
Jacob Husk,
Andre K. Crouch,
Daniel Eichner Tags: SPECIAL ISSUE ‐ RESEARCH ARTICLE Source Type: research
Somatropin therapy in italian adults with growth hormone deficiency
In adult population, Growth Hormone Deficiency (GHD) is a complex clinical condition with heterogeneity of causes and duration. Growth Hormone (GH) replacement therapy has beneficial effects entailing a chroni... (Source: BMC Endocrine Disorders)
Source: BMC Endocrine Disorders - March 3, 2022 Category: Endocrinology Authors: Flavia Pricci, Daniela Rotondi, Marika Villa, Arianna Valerio, Elvira Agazio and Paolo Roazzi Tags: Research article Source Type: research
POSA351 Dyadic Evaluation of Patient and Caregiver Treatment Burden with Once Weekly Growth Hormone (GH) Injection Schedule (SOMATROGON) vs. Once Daily GH Injection Schedule (SOMATROPIN) By Baseline Burden Subgroup in Paediatric Growth Hormone Deficiency (GHD)
To evaluate patient and caregiver perceptions of the treatment burden associated with weekly somatrogon compared to daily somatropin injection in subgroups identified as ‘Not Burdened’ or ‘Burdened’ at baseline (BL). (Source: Value in Health)
Source: Value in Health - January 1, 2022 Category: International Medicine & Public Health Authors: J Loftus, M Stewart, M Resa, A Palladino Source Type: research
Recombinant human growth hormone improves the immune status of rats with septic encephalopathy: The role of VEGFR2 in the prevalence of endoplasmic reticulum stress repair module
Int Immunopharmacol. 2021 Nov 15:108370. doi: 10.1016/j.intimp.2021.108370. Online ahead of print.ABSTRACTSeptic encephalopathy results from the intense reaction of the immune system to infection. The role of growth hormone (GH) signaling in maintaining brain function is well established; however, the involvement of the vascular endothelial growth factor receptor-2 (VEGFR2) in the potential modulatory effect of GH on septic encephalopathy-associated endoplasmic reticulum stress (ERS) and blood-brain barrier (BBB) permeability is not well-understood. Therefore, after the induction of mid-grade sepsis by cecal ligation/perfo...
Source: International Immunopharmacology - November 19, 2021 Category: Allergy & Immunology Authors: Doaa A Zaky Wagdy M Eldehna Ahmed M El Kerdawy Dalaal M Abdallah Hanan S El Abhar Walaa Wadie Source Type: research
Lonapegsomatropin: Pediatric First Approval
This article summarizes the milestones in the development of lonapegsomatropin leading to this first pediatric approval for the treatment of growth hormone deficiency.PMID:34709591 | DOI:10.1007/s40272-021-00478-8 (Source: Paediatric Drugs)
Source: Paediatric Drugs - October 28, 2021 Category: Pediatrics Authors: Yvette N Lamb Source Type: research
Lonapegsomatropin: Pediatric First Approval
This article summarizes the milestones in the development of lonapegsomatropin leading to this first pediatric approval for the treatment of growth hormone deficiency.PMID:34709591 | DOI:10.1007/s40272-021-00478-8 (Source: Paediatric Drugs)
Source: Paediatric Drugs - October 28, 2021 Category: Pediatrics Authors: Yvette N Lamb Source Type: research
