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Meta-analysis application to hERG safety evaluation in clinical trials.
J Biopharm Stat
June 2024
Division of Biometrics VI, Office of Biostatistics, Center for Drug Evaluation and Research, FDA, Silver Spring, MD, USA.
One objective of meta-analysis, which synthesizes evidence across multiple studies, is to assess the consistency and investigate the heterogeneity across studies. In this project, we performed a meta-analysis on moxifloxacin (positive control in QT assessment studies) data to characterize the exposure-response relationship and determine the safety margin associated with 10-msec QTc effects for moxifloxacin based on 26 thorough QT studies submitted to the FDA. Multiple meta-analysis methods were used (including two novel methods) to evaluate the exposure-response relationship and estimate the critical concentration and the corresponding confidence interval of moxifloxacin associated with a 10-msec QTc effect based on the concentration-QTc models.
View Article and Find Full Text PDFThe electrophysiologic effects of KCNQ1 extend beyond expression of IKs: evidence from genetic and pharmacologic block.
Cardiovasc Res
May 2024
Department of Medicine, Vanderbilt University Medical Center, 2215B Garland Ave, 1285 MRBIV, Nashville, TN 37232, USA.
Aims: While variants in KCNQ1 are the commonest cause of the congenital long QT syndrome, we and others find only a small IKs in cardiomyocytes from human-induced pluripotent stem cells (iPSC-CMs) or human ventricular myocytes.
Methods And Results: We studied population control iPSC-CMs and iPSC-CMs from a patient with Jervell and Lange-Nielsen (JLN) syndrome due to compound heterozygous loss-of-function (LOF) KCNQ1 variants. We compared the effects of pharmacologic IKs block to those of genetic KCNQ1 ablation, using JLN cells, cells homozygous for the KCNQ1 LOF allele G643S, or siRNAs reducing KCNQ1 expression.
Decision Analysis: Omadacycline Relative to Moxifloxacin Among Hospitalized Community-Acquired Bacterial Pneumonia Patients at Risk of Clostridioides difficile Infection.
Clin Drug Investig
March 2021
Paratek Pharmaceuticals, Inc., King of Prussia, PA, USA.
Unlabelled: BACKGROUND AND OBJECTIVE: Omadacycline is an aminomethylcycline antibiotic approved in the USA as once-daily intravenous/oral monotherapy for adults with community-acquired bacterial pneumonia (CABP). Omadacycline demonstrated noninferiority to the fluoroquinolone moxifloxacin in a phase III CABP trial; adverse-event rates were similar between treatment groups except for Clostridioides difficile infection (CDI), which occurred in 2% of moxifloxacin-treated patients and 0% of patients on omadacycline. Conceptual healthcare-decision analytic models were developed to better understand the economic implications of antibiotic selection and CDI risk in acute-care facilities.
View Article and Find Full Text PDFAssessing fluoroquinolone-associated aortic aneurysm and dissection: Data mining of the public version of the FDA adverse event reporting system.
Int J Clin Pract
May 2019
Department of Pharmacy Practice, College of Pharmacy and Health Sciences, Western New England University, Springfield, Massachusetts.
Aims: A recent large epidemiological study found fluoroquinolone use is associated with an increased risk of aortic aneurysm or dissection. We aimed to examine fluoroquinolone (ciprofloxacin, levofloxacin and moxifloxacin) associated aortic aneurysm or dissection through data mining of the US Food and Drug Administration Adverse Event Reporting System (FAERS).
Methods: Reports to the FAERS from 1 January 2004 to 31 December 2016 were analysed.
Is oral moxifloxacin associated with bilateral acute iris transillumination?
Acta Ophthalmol
June 2018
Department of Ophthalmology, Middelheim General Hospital, Antwerp, Belgium.
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