This editorial previews and summarizes the content of the current themed issue of J Pharm Tox Methods derived from the recent 2018 Annual Safety Pharmacology Society (SPS) meeting held in Washington, DC. The papers highlight improvements in methods and study endpoints used in non-clinical safety pharmacology (SP) to enhance clinical translatability. Articles cover areas including the SP assessment of oligonucleotides and gene therapy, core battery clinical translation case studies, next generation non-opiate pain management strategy, aspects of cardio-oncology that extend the traditional objectives of an SP assessment, real-world advanced imaging techniques used in preclinical safety, in silico approaches including mathematical modeling, machine learning, and bioinformatics and how secondary SP studies impact clinical trial interpretation and design. The meeting included scientific content from >190 abstracts (reproduced in the current volume of J Pharm Tox Methods).
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| http://dx.doi.org/10.1016/j.vascn.2019.106604 | DOI Listing |
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Patterns of belatacept use and risk of post-transplant lymphoproliferative disorder in US kidney transplant recipients: An analysis of the Organ Procurement and Transplantation Network database.
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Worldwide Health Economics and Outcomes Research, Bristol Myers Squibb, Princeton, NJ, United States of America.
Background: Belatacept is approved for the prophylaxis of organ rejection in Epstein-Barr virus (EBV)-seropositive kidney transplant recipients and is associated with a risk of post-transplant lymphoproliferative disorder (PTLD).
Methods: Data from the Organ Procurement and Transplantation Network were used to examine patterns of belatacept use, describe patient characteristics, and estimate risk of PTLD in EBV-seropositive, kidney-only transplant recipients receiving belatacept- or calcineurin inhibitor (CNI)-based immunosuppression as part of US Food and Drug Administration-mandated safety monitoring.
Results: During the study period (June 15, 2011-June 14, 2016), 94.
Disseminated organ and tissue infection secondary to carbapenem-resistant Klebsiella pneumoniae bloodstream infection for acute lymphoblastic leukemia treated with ceftazidime-avibactam: Two case reports.
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Department of Hematology, Tongde Hospital of Zhejiang Province, Hangzhou, P.R. China.
Rationale: Carbapenem-resistant Klebsiella pneumoniae (CRKP) bloodstream infections are a severe complication resulting from granulocyte deficiency following chemotherapy for hematologic malignancies and have a high mortality rate. However, reports of disseminated organ infections secondary to bloodstream infections are rare.
Patient Concerns And Diagnoses: We report 2 cases of patients with acute lymphoblastic leukemia who both developed CRKP bloodstream infections during the granulocyte deficiency stage following chemotherapy, with 1 case of secondary bacterial liver abscess and 1 case of secondary septic arthritis.
Blind nasoenteric tube placement risks: A case report of misplacement into the pleural cavity.
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Department of Critical Care Medicine, Affiliated Hospital of Zunyi Medical University, Zunyi, Guizhou, People's Republic of China.
Rationale: Enteral nutrition is a critical component of care for critically ill patients. However, the blind insertion of a nasoenteric tube, despite being a simple procedure, carries inherent risks that necessitate a reevaluation of the technique.
Patient Concerns: A case of a 60-year-old female experienced the rare yet critical complication of a misplaced nasoenteric tube entering the thoracic cavity during a blind insertion procedure for enteral nutrition following a liver transplant.
Comparative analysis of general and regional anesthesia applications in geriatric hip fracture surgery.
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Department of Anesthesiology, Affiliated Hospital of Southwest Jiaotong University, The Third People's Hospital of Chengdu, Chengdu, China.
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Methods: A comprehensive literature review was conducted, analyzing studies comparing GA and RA in elderly patients undergoing hip fracture surgery. Studies encompassed various designs, including randomized controlled trials, cohort studies, and meta-analyses.
Comparative efficacy and safety of sitagliptin or gliclazide combined with metformin in treatment-naive patients with type 2 diabetes: A single-center, prospective, randomized, controlled, noninferiority study with genetic polymorphism analysis.
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Department of Endocrinology and Metabolism, Nanfang Hospital, Southern Medical University, Guangzhou, China.
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Methods: In this single-center, randomized, controlled noninferiority trial, 129 treatment-naive patients with T2DM with glucotoxicity (fasting plasma glucose [FPG] ≥ 200 mg/dL and glycated hemoglobin ≥ 9.0%) were randomized to receive sitagliptin plus metformin (n = 66) or gliclazide plus metformin (n = 63) for 12 weeks.
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