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Human Factors in Patient Safety

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https://www.readbyqxmd.com/read/28220555/population-pharmacokinetic-characterization-of-bay-81-8973-a-full-length-recombinant-factor-viii-lessons-learned-importance-of-including-samples-with-factor-viii-levels-below-the-quantitation-limit
#1
D Garmann, S McLeay, A Shah, P Vis, M Maas Enriquez, B A Ploeger
INTRODUCTION: The pharmacokinetics (PK), safety and efficacy of BAY 81-8973, a full-length, unmodified, recombinant human factor VIII (FVIII), were evaluated in the LEOPOLD trials. AIM: The aim of this study was to develop a population PK model based on pooled data from the LEOPOLD trials and to investigate the importance of including samples with FVIII levels below the limit of quantitation (BLQ) to estimate half-life. METHODS: The analysis included 1535 PK observations (measured by the chromogenic assay) from 183 male patients with haemophilia A aged 1-61 years from the 3 LEOPOLD trials...
February 20, 2017: Haemophilia: the Official Journal of the World Federation of Hemophilia
https://www.readbyqxmd.com/read/28220020/randomized-phase-ii-study-of-ramucirumab-or-icrucumab-in-combination-with-capecitabine-in-patients-with-previously-treated-locally-advanced-or-metastatic-breast-cancer
#2
Linda T Vahdat, Rachel Layman, Denise A Yardley, William Gradishar, Mohamad A Salkeni, Anil Abraham Joy, Agustin A Garcia, Patrick Ward, James Khatcheressian, Joseph Sparano, Gladys Rodriguez, Shande Tang, Ling Gao, Rita P Dalal, John Kauh, Kathy Miller
BACKGROUND: Icrucumab (ICR) and ramucirumab (RAM) bind vascular endothelial growth factor (VEGF) receptors 1 and 2 (VEGFR-1 and -2), respectively. This open-label, randomized phase II study evaluated their efficacy and safety in combination with capecitabine (CAP) in patients with previously treated unresectable, locally advanced or metastatic breast cancer. METHODS: Patients were randomly assigned (1:1:1) to receive CAP (1,000 mg/m(2) orally twice daily, days 1-14) alone or in combination with RAM (10 mg/kg intravenously [IV], days 1 and 8) (RAM + CAP) or ICR (12 mg/kg IV, days 1 and 8) (ICR + CAP) every 21 days...
February 20, 2017: Oncologist
https://www.readbyqxmd.com/read/28213566/a-randomised-phase-iib-study-of-mavrilimumab-a-novel-gm-csf-receptor-alpha-monoclonal-antibody-in-the-treatment-of-rheumatoid-arthritis
#3
Gerd R Burmester, Iain B McInnes, Joel Kremer, Pedro Miranda, Mariusz Korkosz, Jiri Vencovsky, Andrea Rubbert-Roth, Eduardo Mysler, Matthew A Sleeman, Alex Godwood, Dominic Sinibaldi, Xiang Guo, Wendy I White, Bing Wang, Chi-Yuan Wu, Patricia C Ryan, David Close, Michael E Weinblatt
OBJECTIVES: Despite the therapeutic value of current rheumatoid arthritis (RA) treatments, agents with alternative modes of action are required. Mavrilimumab, a fully human monoclonal antibody targeting the granulocyte-macrophage colony-stimulating factor receptor-α, was evaluated in patients with moderate-to-severe RA. METHODS: In a phase IIb study (NCT01706926), patients with inadequate response to ≥1 synthetic disease-modifying antirheumatic drug(s), Disease Activity Score 28 (DAS28)-C reactive protein (CRP)/erythrocyte sedimentation rate ≥3...
February 17, 2017: Annals of the Rheumatic Diseases
https://www.readbyqxmd.com/read/28207670/feasibility-study-of-utilization-of-action-camera-gopro-hero-4-google-glass-and-panasonic-hx-a100-in-spine-surgery
#4
Chang Kyu Lee, Youngjun Kim, Nam Lee, Byeongwoo Kim, Doyoung Kim, Seong Yi
STUDY DESIGN: Study for feasibility of commercially available action cameras in recording video of spine. OBJECTIVE: Recent innovation of the wearable action camera with high-definition video recording enables surgeons to use camera in the operation at ease without high costs. The purpose of this study is to compare the feasibility, safety, and efficacy of commercially available action cameras in recording video of spine surgery. SUMMARY OF BACKGROUND DATA: There are early reports of medical professionals using Google Glass throughout the hospital, Panasonic HX-A100 action camera, and GoPro...
February 15, 2017: Spine
https://www.readbyqxmd.com/read/28202772/high-throughput-screening-of-tyrosine-kinase-inhibitor-cardiotoxicity-with-human-induced-pluripotent-stem-cells
#5
Arun Sharma, Paul W Burridge, Wesley L McKeithan, Ricardo Serrano, Praveen Shukla, Nazish Sayed, Jared M Churko, Tomoya Kitani, Haodi Wu, Alexandra Holmström, Elena Matsa, Yuan Zhang, Anusha Kumar, Alice C Fan, Juan C Del Álamo, Sean M Wu, Javid J Moslehi, Mark Mercola, Joseph C Wu
Tyrosine kinase inhibitors (TKIs), despite their efficacy as anticancer therapeutics, are associated with cardiovascular side effects ranging from induced arrhythmias to heart failure. We used human induced pluripotent stem cell-derived cardiomyocytes (hiPSC-CMs), generated from 11 healthy individuals and 2 patients receiving cancer treatment, to screen U.S. Food and Drug Administration-approved TKIs for cardiotoxicities by measuring alterations in cardiomyocyte viability, contractility, electrophysiology, calcium handling, and signaling...
February 15, 2017: Science Translational Medicine
https://www.readbyqxmd.com/read/28199174/role-of-troponins-i-and-t-and-n-terminal-prohormone-of-brain-natriuretic-peptide-in-monitoring-cardiac-safety-of-patients-with-early-stage-human-epidermal-growth-factor-receptor-2-positive-breast-cancer-receiving-trastuzumab-a-herceptin-adjuvant-study-cardiac
#6
Dimitrios Zardavas, Thomas M Suter, Dirk J Van Veldhuisen, Jutta Steinseifer, Johannes Noe, Sabine Lauer, Nedal Al-Sakaff, Martine J Piccart-Gebhart, Evandro de Azambuja
Purpose Women receiving trastuzumab with chemotherapy are at risk for trastuzumab-related cardiac dysfunction (TRCD). We explored the prognostic value of cardiac markers (troponins I and T, N-terminal prohormone of brain natriuretic peptide [NT-proBNP]) to predict baseline susceptibility to develop TRCD. We examined whether development of cardiac end points or significant left ventricular ejection fraction (LVEF) drop was associated with markers' increases. Patients and Methods Cardiac marker assessments were coupled with LVEF measurements at different time points for 533 patients from the Herceptin Adjuvant (HERA) study who agreed to participate in this study...
October 23, 2016: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28186707/mesenchymal-stromal-cell-therapy-for-chronic-lung-allograft-dysfunction-results-of-a-first-in-man-study
#7
Daniel C Chambers, Debra Enever, Sharon Lawrence, Marian J Sturm, Richard Herrmann, Stephanie Yerkovich, Michael Musk, Peter M A Hopkins
Chronic lung transplant rejection (termed chronic lung allograft dysfunction [CLAD]) is the main impediment to long-term survival after lung transplantation. Bone marrow-derived mesenchymal stromal cells (MSCs) represent an attractive cell therapy in inflammatory diseases, including organ rejection, given their relative immune privilege and immunosuppressive and tolerogenic properties. Preclinical studies in models of obliterative bronchiolitis and human trials in graft versus host disease and renal transplantation suggest potential efficacy in CLAD...
February 1, 2017: Stem Cells Translational Medicine
https://www.readbyqxmd.com/read/28186187/factors-associated-with-aberrant-imprint-methylation-and-oligozoospermia
#8
Norio Kobayashi, Naoko Miyauchi, Nozomi Tatsuta, Akane Kitamura, Hiroaki Okae, Hitoshi Hiura, Akiko Sato, Takafumi Utsunomiya, Nobuo Yaegashi, Kunihiko Nakai, Takahiro Arima
Disturbingly, the number of patients with oligozoospermia (low sperm count) has been gradually increasing in industrialized countries. Epigenetic alterations are believed to be involved in this condition. Recent studies have clarified that intrinsic and extrinsic factors can induce epigenetic transgenerational phenotypes through apparent reprogramming of the male germ line. Here we examined DNA methylation levels of 22 human imprinted loci in a total of 221 purified sperm samples from infertile couples and found methylation alterations in 24...
February 10, 2017: Scientific Reports
https://www.readbyqxmd.com/read/28185075/paediatric-patient-safety-and-the-need-for-aviation-black-box-thinking-to-learn-from-and-prevent-medication-errors
#9
Chi Huynh, Ian C K Wong, Jo Correa-West, David Terry, Suzanne McCarthy
Since the publication of To Err Is Human: Building a Safer Health System in 1999, there has been much research conducted into the epidemiology, nature and causes of medication errors in children, from prescribing and supply to administration. It is reassuring to see growing evidence of improving medication safety in children; however, based on media reports, it can be seen that serious and fatal medication errors still occur. This critical opinion article examines the problem of medication errors in children and provides recommendations for research, training of healthcare professionals and a culture shift towards dealing with medication errors...
February 10, 2017: Paediatric Drugs
https://www.readbyqxmd.com/read/28183331/phase-ii-randomized-placebo-controlled-study-of-dovitinib-in-combination-with-fulvestrant-in-postmenopausal-patients-with-hr-her2-breast-cancer-that-had-progressed-during-or-after-prior-endocrine-therapy
#10
Antonino Musolino, Mario Campone, Patrick Neven, Neelima Denduluri, Carlos H Barrios, Javier Cortes, Kimberly Blackwell, Hatem Soliman, Zsuzsanna Kahan, Hervé Bonnefoi, Matthew Squires, Yong Zhang, Stephanie Deudon, Michael M Shi, Fabrice André
BACKGROUND: Overexpression of fibroblast growth factor receptor 1 (FGFR1), found in ≤8% of hormone receptor-positive (HR(+)), human epidermal growth factor receptor 2-negative (HER2(-)) breast cancer cases, is correlated with decreased overall survival and resistance to endocrine therapy (ET). Dovitinib, a potent FGFR inhibitor, has demonstrated antitumor activity in heavily pretreated patients with FGFR pathway-amplified breast cancer. METHODS: In this randomized, placebo-controlled phase II trial, we evaluated whether the addition of dovitinib to fulvestrant would improve outcomes in postmenopausal patients with HR(+), HER2(-) advanced breast cancer that had progressed during or after prior ET...
February 10, 2017: Breast Cancer Research: BCR
https://www.readbyqxmd.com/read/28176010/clinical-potentials-of-human-pluripotent-stem-cells
#11
REVIEW
Cristina Mora, Marialaura Serzanti, Antonella Consiglio, Maurizio Memo, Patrizia Dell'Era
Aging, injuries, and diseases can be considered as the result of malfunctioning or damaged cells. Regenerative medicine aims to restore tissue homeostasis by repairing or replacing cells, tissues, or damaged organs, by linking and combining different disciplines including engineering, technology, biology, and medicine. To pursue these goals, the discipline is taking advantage of pluripotent stem cells (PSCs), a peculiar type of cell possessing the ability to differentiate into every cell type of the body. Human PSCs can be isolated from the blastocysts and maintained in culture indefinitely, giving rise to the so-called embryonic stem cells (ESCs)...
February 8, 2017: Cell Biology and Toxicology
https://www.readbyqxmd.com/read/28161880/long-term-safety-and-efficacy-of-omnitrope-%C3%A2-in-adults-with-growth-hormone-deficiency-italian-interim-analysis-of-the-patro-adults-study
#12
D Ferone, E Profka, V Gasco, M R Ambrosio, A Colao, C Di Somma, E Puxeddu, G Arnaldi, C Pagano, E Zecchi, A Pietropoli, P Beck-Peccoz
PURPOSE: To report the long-term effectiveness and safety of the recombinant human growth hormone Omnitrope(®), a somatropin biosimilar to Genotropin(®), in Italian patients with growth hormone deficiency (GHD) enrolled in the PATRO Adults study. METHODS: The PATRO Adults study is an ongoing observational, longitudinal, non-interventional global post-marketing surveillance study, conducted in several European countries. The primary endpoint is long-term safety; secondary endpoints include the effectiveness of Omnitrope(®), which was assessed using serum insulin-like growth factor-1 levels, body composition, bone mineral density and lipid levels...
February 4, 2017: Journal of Endocrinological Investigation
https://www.readbyqxmd.com/read/28159040/recombinant-human-platelet-derived-growth-factor-bb-versus-autologous-bone-graft-in-foot-and-ankle-fusion-a-systematic-review-and-meta-analysis
#13
Han Sun, Pei-Pei Lu, Ping-Hui Zhou, Si-Wei Sun, Hong-Tao Zhang, Yi-Jie Liu, Xu Yang, Xiao-Feng Shen, Hui-Lin Yang
Today, autogenous bone graft (ABG) is still considered as the gold standard for joint fusion. Recombinant human platelet-derived growth factor-BB (rhPDGF-BB) which is of chemotactic and mitogenic to mesenchymal stem cells and possesses outstanding osteogenetic potentials has been used for ankle and foot fusion in recent years. The goal of this article is to evaluate the safety and efficacy of rhPDGF-BB versus ABG in foot and ankle fusion. The PubMed MEDLINE, EMBASE, Web of Science, and Cochrane Library were systematic searched...
March 2017: Foot and Ankle Surgery: Official Journal of the European Society of Foot and Ankle Surgeons
https://www.readbyqxmd.com/read/28150517/human-biology-based-drug-safety-evaluation-scientific-rationale-current-status-and-future-challenges
#14
J Gerry Kenna
Animal toxicity studies used to assess the safety of new candidate pharmaceuticals prior to their progression into human clinical trials are unable to assess the risk of non-pharmacologically mediated idiosyncratic adverse drug reactions (ADRs), the most frequent of which are drug-induced liver injury and cardiotoxicity. Idiosyncratic ADRs occur only infrequently and in certain susceptible humans, but are caused by many hundreds of different drugs and may lead to serious illness. Areas covered: Idiosyncratic ADRs are initiated by drug-related chemical insults, which cause toxicity due to susceptibility factors that manifest only in certain patients...
February 2, 2017: Expert Opinion on Drug Metabolism & Toxicology
https://www.readbyqxmd.com/read/28144730/phase-1-study-of-new-formulation-of-patritumab-u3-1287-process-2-a-fully-human-anti-her3-monoclonal-antibody-in-combination-with-erlotinib-in-japanese-patients-with-advanced-non-small-cell-lung-cancer
#15
Toshio Shimizu, Kimio Yonesaka, Hidetoshi Hayashi, Tsutomu Iwasa, Koji Haratani, Hironori Yamada, Shoichi Ohwada, Emi Kamiyama, Kazuhiko Nakagawa
BACKGROUND: This phase 1 study evaluated the safety, tolerability, pharmacokinetics and efficacy of patritumab (U3-1287) Process 2, a new formulation of fully human anti-HER3 monoclonal antibody in combination with erlotinib, an epidermal growth factor receptortyrosine kinase inhibitor (EGFR-TKI) in prior chemotherapy treated Japanese patients with advanced non-small cell lung cancer (NSCLC). METHODS: Patients received intravenous patritumab Process 2 formulation at 9 mg/kg every 3 weeks after initiation of 18 mg/kg loading dose combined with continuous daily dose of erlotinib (150 mg QD) until any of the withdrawal criteria are met...
January 31, 2017: Cancer Chemotherapy and Pharmacology
https://www.readbyqxmd.com/read/28144129/spotlight-on-mavrilimumab-for-the-treatment-of-rheumatoid-arthritis-evidence-to-date
#16
REVIEW
Chiara Crotti, Maria Gabriella Raimondo, Andrea Becciolini, Martina Biggioggero, Ennio Giulio Favalli
The introduction of biological therapies into clinical practice has dramatically modified the natural history of chronic inflammatory diseases, such as rheumatoid arthritis (RA). RA is a systemic autoimmune disease that causes articular damage and has a great negative impact on patients' quality of life. Despite the wide spectrum of available biological treatments, ~30% of RA patients are still unresponsive, resulting in high disability and increased morbidity and mortality. In the last few decades, the scientific knowledge on RA pathogenesis vastly improved, leading to the identification of new proinflammatory molecules as potential therapeutic targets...
2017: Drug Design, Development and Therapy
https://www.readbyqxmd.com/read/28143428/bk-um-in-patients-with-recurrent-ovarian-cancer-or-peritoneal-cancer-a-first-in-human-phase-i-study
#17
Shingo Miyamoto, Fusanori Yotsumoto, Taeko Ueda, Tatsuya Fukami, Ayako Sanui, Kohei Miyata, Sung Ouk Nam, Satoshi Fukagawa, Takahiro Katsuta, Miyako Maehara, Haruhiko Kondo, Daisuke Miyahara, Kyoko Shirota, Toshiyuki Yoshizato, Masahide Kuroki, Hiroaki Nishikawa, Keijiro Saku, Yoshio Tsuboi, Kenji Ishitsuka, Yasushi Takamatsu, Kazuo Tamura, Akira Matsunaga, Toru Hachisuga, Shinsuke Nishino, Takashi Odawara, Kazuhiro Maeda, Sadao Manabe, Toyokazu Ishikawa, Yoshinobu Okuno, Minako Ohishi, Tomoya Hikita, Hiroto Mizushima, Ryo Iwamoto, Eisuke Mekada
BACKGROUND: BK-UM (CRM197) is a mutant form of diphtheria toxin and a specific inhibitor of heparin-binding epidermal growth factor-like growth factor (HB-EGF). We assessed the safety, pharmacokinetics, recommended dose, and efficacy of BK-UM in patients with recurrent ovarian cancer (OC) or peritoneal cancer (PC), and measured HB-EGF levels in serum and abdominal fluid after BK-UM administration. METHODS: Eleven patients with advanced or recurrent OC or PC were enrolled and treated with BK-UM via the intraperitoneal route...
January 31, 2017: BMC Cancer
https://www.readbyqxmd.com/read/28128088/gestational-pityriasis-rosea-suggestions-for-approaching-affected-pregnant-women
#18
Alexandra Monastirli, Efstathia Pasmatzi, George Badavanis, Dionysios Tsambaos
Dear Editor, Pityriasis rosea is a common, acute, and self-limiting dermatosis, which is associated with the endogenous systemic reactivation of human herpesvirus (HHV)-6 and/or HHV-7 (1). It predominantly affects individuals of both sexes in their second or third decade of life and is clinically characterized by the occurrence of an initial erythematosquamous plaque followed by the appearance of disseminated similar but smaller lesions one or two weeks later. Several patients develop systemic symptoms such as nausea, anorexia, malaise, headache, fever, arthralgia, and lymphadenopathy that may precede or accompany the eruption; the latter follows the cleavage lines of the trunk creating the configuration of a Christmas tree and spontaneously resolves within 4 to 8 weeks...
December 2016: Acta Dermatovenerologica Croatica: ADC
https://www.readbyqxmd.com/read/28126447/ehtic-study-evaluation-of-a-new-hemostatic-agent-based-on-tissue-factor-in-skin-grafting-procedures
#19
Santiago Rojas, M Dolores Pérez Del Caz, Juan Ramón Esteban Vico, Eloísa Villaverde, Abel Llinas, José Ramón Martínez, Carlos Brage, Javier Valero, Alba González Rodríguez, Juan Garcia Barreiro, Eugenia López-Suso, Jose Luis Fernandez-Cañamaque, Ramón López, Jesus Murat
BACKGROUND: Excessive bleeding is a major concern in scar debridement and grafting procedures. TT-173 is a new topical hemostatic agent based on recombinant human tissue factor that has shown promising results in patients who underwent tooth extraction. EHTIC study sought to evaluate the efficacy and safety of TT-173 to reduce the bleeding in donor sites of skin grafting procedures. METHODS: EHTIC study was a phase II, randomized, parallel, double blind, placebo controlled trial...
January 23, 2017: Burns: Journal of the International Society for Burn Injuries
https://www.readbyqxmd.com/read/28125304/omalizumab-for-treating-chronic-spontaneous-urticaria-an-expert-review-on-efficacy-and-safety
#20
Ana M Giménez-Arnau
Chronic spontaneous urticaria (CSU) is characterized by the recurrence of itchy hives and/or angioedema for greater than six weeks, with no known external trigger. Omalizumab, a humanized, recombinant, monoclonal anti-IgE antibody, is the only approved add-on therapy for H1-antihistamine refractory CSU patients. Areas covered: The objective of this article is to discuss the mechanism of action, pharmacokinetics and pharmacodynamics of omalizumab for the treatment of CSU. The review also summarizes efficacy and safety data from proof-of-concept, Phase II (X-QUISITE, MYSTIQUE), and pivotal Phase III omalizumab studies (ASTERIA I, ASTERIA II, and GLACIAL)...
January 26, 2017: Expert Opinion on Biological Therapy
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