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Matthias M Weber, Beverly Mk Biller, Birgitte Tønnes Pedersen, Effie Pournara, Jens Sandahl Christiansen, Charlotte Höybye
OBJECTIVE: To assess the effect of 4 years' GH replacement on glucose homeostasis and evaluate factors affecting glycosylated haemoglobin (HbA1c ) in adults with GH deficiency (GHD). DESIGN: NordiNet(®) International Outcome Study, a non-interventional study, monitors long-term effectiveness and safety of GH-replacement (Norditropin(®) [somatropin], Novo Nordisk A/S) in real-life clinical practice. PATIENTS: Non-diabetic patients (n=245) with adult-onset GHD (age ≥20 years at GH start), ≥4 years' GH replacement and HbA1c values at baseline and 4 years were included in the analysis...
October 13, 2016: Clinical Endocrinology
Ahmad Amini
Purity determination of somatropin as a recombinant protein is important to ensure its safety and quality. This is carried out by capillary zone electrophoresis in double-injection mode using polybrene/chondroitin sulfate A double-coated capillaries. Modification of the capillary wall eliminates protein-wall interactions which results in improved accuracy and precision of the determinations. In the double-injection mode two somatropin samples are analyzed within a single electrophoretic run. Prior to the second injection, the first injected plug is electrophoresed for a predetermined time period in order to adjust the inter-plug distance...
2016: Methods in Molecular Biology
Mamdouh R Rezk, Mostafa A Shehata, Marwa F Mohamed, Faten Abdel Aziz Fathalla
A selective, rapid size-exclusion chromatographic method was developed and validated for the separation of the human growth hormone (hGH) somatropin from its high-molecular-weight aggregates. Separation was achieved using a nontoxic mobile phase compared with the official method of the European Pharmacopoeia that uses 2-propanol in a mobile phase. The developed method used a YMC-Pack Diol (YMC Karasuma, Kyoto, Japan; 300 × 8.0 mm, 5 μm) analytical column. The mobile phase was formed with a pH 7phosphate buffer that was pumped at a flow rate of 1 mL/min with UV detection at 214 nm...
September 2016: Journal of AOAC International
Lars Sävendahl, Effie Pournara, Birgitte Tønnes Pedersen, Oliver Blankenstein
OBJECTIVE: Concerns have been raised of increased mortality risk in adulthood in certain patients who received growth hormone treatment during childhood. This study evaluated the safety of growth hormone treatment in childhood in everyday practice. DESIGN: NordiNet(®) International Outcome Study (IOS) is a noninterventional, observational study evaluating safety and effectiveness of Norditropin(®) (somatropin; Novo Nordisk A/S, Bagsvaerd, Denmark). METHODS: Long-term safety data (1998-2013) were collected on 13 834 growth hormone treated pediatric patients with short stature...
May 2016: European Journal of Endocrinology
Sun J Kim, Chan W Kim
The purpose of this study was to develop and characterize a sodium hyaluronate microparticle-based sustained release formulation of recombinant human growth hormone (SR-rhGH) prepared by spray-drying. Compared to freeze-drying, spray-dried SR-rhGH showed not only prolonged release profiles but also better particle property and injectability. The results of size-exclusion high-performance liquid chromatography showed that no aggregate was detected, and dimer was just about 2% and also did not increase with increase of inlet temperature up to 150 °C...
February 2016: Journal of Pharmaceutical Sciences
Michael Højby Rasmussen, Jurgita Janukonyté, Marianne Klose, Djordje Marina, Mette Tanvig, Lene F Nielsen, Charlotte Höybye, Marianne Andersen, Ulla Feldt-Rasmussen, Jens Sandahl Christiansen
CONTEXT: NNC0195-0092 is a reversible, albumin-binding GH derivative, developed for once-weekly administration. OBJECTIVES: The objective of the study was to evaluate safety, local tolerability, pharmacodynamics, and pharmacokinetics of multiple, once-weekly doses of NNC0195-0092, compared with daily GH. DESIGN AND SETTING: This was a phase 1, randomized, open-label, active-controlled, multiple-dose, dose-escalation trial. PATIENTS: Thirty-four GH-treated adult subjects (male, n = 25) with GH deficiency participated in the study...
March 2016: Journal of Clinical Endocrinology and Metabolism
Murray B Gordon, Richard A Levy, Robert Gut, John Germak
OBJECTIVE: Adult growth hormone deficiency (AGHD) results in physiologic impairments that may reduce quality of life and negatively impact body composition. AGHD can be treated with recombinant human growth hormone (GH). This study analyzes AGHD patients enrolled in the American Norditropin(®) STUDIES: Web-Enabled-Research (ANSWER) Program/NovoNet, a U.S. observational noninterventional study of patients treated with Norditropin(®) (somatropin [recombinant DNA origin] injection) at the discretion of their physicians...
April 2016: Endocrine Practice
L L Lemos, M R Silva, J B Santos, Costa Jd, R M Gomes, R C Nascimento, A M Almeida, A A Guerra Júnior
No abstract text is available yet for this article.
November 2015: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
Stella Stergiopoulos, Kenneth Getz
Historical studies of voluntary, spontaneous drug reports show poor attribution of adverse events to generic versions of commonly prescribed medications. As biosimilars enter the market place, it may be similarly difficult to accurately attribute adverse events to their respective reference products. At this time, lack of global consensus with regard to biosimilar naming conventions may result in drug reporting confusion, misattribution of adverse events and insufficient active monitoring of safety signals...
August 2015: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
Tiago Lopes Coelho, Felipe Ferré, Orozimbo Henriques Campos Neto, Francisco de Assis Acurcio, Mariângela Leal Cherchiglia, Eli Iola Gurgel Andrade
OBJECTIVE: To investigate the factors related to the granting of preliminary court orders [injunctions] in drug litigations. METHODS: A retrospective descriptive study of drug lawsuits in the State of Minas Gerais, Southeastern Brazil, was conducted from October 1999 to 2009. The database consists of 6,112 lawsuits, out of which 6,044 had motions for injunctions and 5,167 included the requisition of drugs. Those with more than one beneficiary were excluded, which totaled 5,072 examined suits...
October 2014: Revista de Saúde Pública
Helen A Spoudeas, Priti Bajaj, Nathan Sommerford
PURPOSE: Persistence and adherence with subcutaneous growth hormone (GH; somatropin) therapy in children is widely acknowledged to be suboptimal. This study aimed to investigate how the use of a jet-delivery device, ZomaJet(®), impacts on medication-taking behaviors compared to needle-based devices. MATERIALS AND METHODS: A retrospective cohort study of children aged ≤18 years was conducted using a UK-based, nationwide database of GH home-delivery schedules. Data were evaluated for the period between January 2010 and December 2012 for 6,061 children receiving either Zomacton(®) (somatropin) via the ZomaJet jet-delivery device or one of six brands of GH all administered via needle-based devices...
2014: Patient Preference and Adherence
Ahmad Amini
This paper presents a new approach for identifying analytes by CE. The compound to be identified is analyzed together with the corresponding reference standard during a double injection capillary electrophoretic run. The inter-plug distance is regulated by applying an electrical field over the capillary for a predetermined time period (t(PE)). The migration time of an analyte being exposed to the partial electrophoresis was calculated from the partial migration time (t(mig(p))) as described in this paper. The identification is based on the closeness of agreement between the calculated migration time (t(mig(c))) and observed migration time (t(mig)) of the reference standard...
October 2014: Electrophoresis
Halvard Bonig, Petra S Becker, Arnd Schwebig, Matthew Turner
Biosimilars are approved biologics with comparable quality, safety, and efficacy to a reference product. Unlike generics, which are chemically manufactured copies of small-molecule drugs with relatively simple chemical structures, the biosimilar designation is applied to drugs that are produced by living organisms, implying much more difficult to control manufacturing and purification procedures. To account for these complexities, the European Medicines Agency (EMA), the US Food and Drug Administration, the Australian Therapeutic Goods Administration, and other regulatory authorities have devised and implemented specific, markedly more demanding pathways for the evaluation and approval of biosimilars...
February 2015: Transfusion
Abdul Qader Abbady, Rasha Al-Shemali, Jana Mir Assaad, Hossam Murad
Growth hormone (GH) deficiencies are diagnosed in most children with short stature and treated with a long course of administrating expensive and daily doses of recombinant human GH (rhGH or Somatropin®). This work describes for the first time the production of several GH specific nanobodies with great potential in the field of GH production and detection. Nanobodies are the smallest intact antigen binders derived from heavy chain-only antibodies (HCAbs) of camelids. They are very stable, highly soluble and are produced as recombinant proteins in Escherichiacoli at an affordable cost for various biotechnological applications...
August 1, 2014: General and Comparative Endocrinology
Andreas M Pleil, Feyza Darendeliler, Helmuth G Dörr, Katherine Hutchinson, Hartmut A Wollmann
UNLABELLED: Previous research has reported that ease of use of and preference for a delivery device are associated with greater patient compliance - an important factor in achieving optimal therapeutic results. The objective of this study was to assess the ease-of-use of a new disposable pen (GoQuick(®), Pfizer, Inc.) versus the current reusable pen (GENOTROPIN Pen(®), Pfizer, Inc.) to inject a daily dose of recombinant DNA origin human growth hormone, Genotropin(®) (somatropin) in standard practice...
2014: Medical Devices: Evidence and Research
Nathalie Bracke, Evelien Wynendaele, Matthias D'Hondt, Rob Haselberg, Govert W Somsen, Ewald Pauwels, Christoph Van de Wiele, Bart De Spiegeleer
Chemical modification of biomolecules like the introduction of metal-chelators into proteins can lead to heterogeneous product formation. The nature and extend of the modification is important in interpreting the biological properties of the bioconjugate, given their possible influence on the pharmacokinetics as well as on the binding affinity to the target. The present study describes the synthesis and analytical characterization of somatropin modified on its lysine's ɛ-amino groups with the acylating chelator S-2-(4-isothiocyanatobenzyl)-1,4,7-triazacyclononane-1,4,7-triacetic acid (p-SCN-Bn-NOTA)...
August 5, 2014: Journal of Pharmaceutical and Biomedical Analysis
Hans-Peter Schwarz, Dorota Birkholz-Walerzak, Mieczyslaw Szalecki, Mieczyslaw Walczak, Corina Galesanu, David Metreveli, Jasmin Khan-Boluki, Ellen Schuck
BACKGROUND: This prospective, open-label, non-comparative, multicentre, long-term phase IV study is examining the efficacy and safety of somatropin [recombinant human growth hormone (rhGH)] in short children born small for gestational age (SGA) and its impact on the incidence of diabetes. This report is the first interim analysis of patients who have completed 1 year of treatment. METHODS: A total of 278 pre-pubertal patients were enrolled. Key eligibility criteria included height standard deviation score (HSDS) <-2...
December 2014: Biologics in Therapy
Palle B Jeppesen
A primary goal of intestinal rehabilitation programs is to facilitate intestinal adaptation. Adult patients with short bowel syndrome (SBS) who are dependent on parenteral nutrition and/or intravenous fluid (PN/IV) support have 2 hormonal pharmacologic treatment options available that may promote intestinal growth: a glucagon-like peptide 2 analog (teduglutide) and recombinant human growth hormone (somatropin). In two phase III clinical trials (N=169), 24 weeks of teduglutide administered to outpatients with SBS resulted in significant decreases in PN/IV volume requirements of 2...
May 2014: JPEN. Journal of Parenteral and Enteral Nutrition
Sandro Curto, Simone Ghislandi, Katelijne van de Vooren, Silvy Duranti, Livio Garattini
OBJECTIVE: The goal of the present study is to assess the awarded prices and thus the real level of competition the regional tenders referring to biosimilars in Italy achieved. METHODS: We conducted a web-based analysis to collect detailed information on regional biosimilar tenders, up to December 2012. We identified 191 lots referring to the three off-patent biologicals (somatropin, epoetin and filgrastim) mentioned in the 24 tenders that took place during the study period (2008-2012)...
June 2014: Health Policy
Kelly A Tappenden
Intestinal adaptation is a natural compensatory process that occurs following extensive intestinal resection, whereby structural and functional changes in the intestine improve nutrient and fluid absorption in the remnant bowel. In animal studies, postresection structural adaptations include bowel lengthening and thickening and increases in villus height and crypt depth. Functional changes include increased nutrient transporter expression, accelerated crypt cell differentiation, and slowed transit time. In adult humans, data regarding adaptive changes are sparse, and the mechanisms underlying intestinal adaptation remain to be fully elucidated...
May 2014: JPEN. Journal of Parenteral and Enteral Nutrition
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