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Article ; Online: Fomepizole should not be used more liberally in paracetamol overdose.

Dear, James W

British journal of clinical pharmacology

2022 Volume 89, Issue 2, Page(s) 599–601

Abstract: Fomepizole is a promising new treatment for preventing liver injury following paracetamol (acetaminophen) overdose. However, we need robust clinical trials to be performed to demonstrate its effect on clinical outcomes that are important to our patients ... ...

Abstract	Fomepizole is a promising new treatment for preventing liver injury following paracetamol (acetaminophen) overdose. However, we need robust clinical trials to be performed to demonstrate its effect on clinical outcomes that are important to our patients and important to healthcare providers. Until such trials are performed, the toxicology community should learn the lessons from the COVID pandemic-potential novel therapeutic options may be theoretically appealing, but their effectiveness needs to be assessed in robust clinical trials before they are used in clinical practice.
MeSH term(s)	Humans ; Acetaminophen ; Analgesics, Non-Narcotic/therapeutic use ; Fomepizole/therapeutic use ; Acetylcysteine/therapeutic use ; COVID-19 ; Drug Overdose/drug therapy ; Chemical and Drug Induced Liver Injury/etiology ; Chemical and Drug Induced Liver Injury/prevention & control
Chemical Substances	Acetaminophen (362O9ITL9D) ; Analgesics, Non-Narcotic ; Fomepizole (83LCM6L2BY) ; Acetylcysteine (WYQ7N0BPYC)
Language	English
Publishing date	2022-12-05
Publishing country	England
Document type	Journal Article
ZDB-ID	188974-6
ISSN	1365-2125 ; 0306-5251 ; 0264-3774
ISSN (online)	1365-2125
ISSN	0306-5251 ; 0264-3774
DOI	10.1111/bcp.15596
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Article ; Online: Developing new antidotes for poisons with existing effective treatments: a case study of fomepizole in paracetamol poisoning.

Dear, James W / Bateman, D Nicholas

Clinical toxicology (Philadelphia, Pa.)

2023 Volume 61, Issue 8, Page(s) 577–580

Abstract: Introduction: Acetylcysteine is the only effective and licensed therapy for paracetamol poisoning. However, acetylcysteine loses efficacy if treatment is delayed 8-12 hours after paracetamol ingestion, and there is also uncertainty as to whether the ... ...

Abstract	Introduction: Acetylcysteine is the only effective and licensed therapy for paracetamol poisoning. However, acetylcysteine loses efficacy if treatment is delayed 8-12 hours after paracetamol ingestion, and there is also uncertainty as to whether the dose should be increased in high-risk paracetamol ingestions. Studies have identified potential therapeutic targets, including enzymes that metabolize paracetamol; the pathways causing mitochondrial toxicity Historical background: When the first treatments for paracetamol toxicity were developed, the clinical trial and ethical basis of practice were different from today. Acetylcysteine was never subjected to placebo-controlled studies, even by the United States Food and Drug Administration, as it was presumed that the toxicity of high paracetamol concentrations was so evident that placebo-controlled studies were unethical. Thus, the absolute benefit of acetylcysteine remains unknown. In addition, no dose-ranging studies of acetylcysteine in patients were ever done. The weakness of assessing the efficacy of additional antidotes in small groups of patients with moderate poisoning is illustrated by the use of cimetidine in paracetamol poisoning. Current approaches to drug (and antidote) development: The approach required by regulatory authorities today relies on several important steps. First, a clear target for therapeutic effect is sought, normally in a laboratory model. Next, a 'proof of principle' study is required to demonstrate that the target is 'druggable'. Finally, clinical studies to confirm proof of principle applies in humans, followed by a controlled trial with matched patient groups with sufficient power to demonstrate the clinical outcome being sought. Such patient studies can be expensive to conduct, and non-commercial groups suffer the risk of not being funded. Fomepizole: Fomepizole prevents paracetamol-induced hepatic toxicity in mice by inhibiting cytochrome P4502E1, thereby preventing the conversion of paracetamol to its toxic metabolite. Fomepizole also inhibits c-Jun N-terminal kinases, a key pathway in the downstream toxicity on the mitochondria. The present evidence of efficacy in humans is based on small case series with no control groups. The availability of a licensed indication has facilitated off-label use of fomepizole in an unproven indication. Conclusions: Paracetamol poisoning is common, and randomized, controlled clinical trials are possible. The benefit of fomepizole can only be shown by such a study. As clinical trials using fomepizole as an added therapy to acetylcysteine are recruiting in the United States, these should be supported by all clinical toxicologists. In the interim, the publication of small case series using fomepizole should be discouraged by journals.
MeSH term(s)	Humans ; Animals ; Mice ; Antidotes/therapeutic use ; Fomepizole ; Acetaminophen ; Acetylcysteine/therapeutic use ; Poisons
Chemical Substances	Antidotes ; Fomepizole (83LCM6L2BY) ; Acetaminophen (362O9ITL9D) ; Acetylcysteine (WYQ7N0BPYC) ; Poisons
Language	English
Publishing date	2023-10-10
Publishing country	England
Document type	Journal Article
ZDB-ID	204476-6
ISSN	1556-9519 ; 0009-9309 ; 0731-3810 ; 1556-3650
ISSN (online)	1556-9519
ISSN	0009-9309 ; 0731-3810 ; 1556-3650
DOI	10.1080/15563650.2023.2259085
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Article ; Online: Novel biomarkers for drug-induced liver injury.

Humphries, Christopher / Dear, James W

Clinical toxicology (Philadelphia, Pa.)

2023 Volume 61, Issue 8, Page(s) 567–572

Abstract: Introduction: Liver toxicity due to medicines (drug-induced liver injury) is a challenge for clinicians and drug developers. There are well-established biomarkers of drug-induced liver injury, which are widely used and validated by decades of clinical ... ...

Abstract	Introduction: Liver toxicity due to medicines (drug-induced liver injury) is a challenge for clinicians and drug developers. There are well-established biomarkers of drug-induced liver injury, which are widely used and validated by decades of clinical experience. These include alanine aminotransferase and bilirubin. Limitations of the current biomarkers are well described, and this has resulted in global efforts to identify and develop new candidates. This process has been aided by regulatory pathways being established for biomarker qualification. This article aims to provide a broad overview of the mechanisms of liver toxicity and discuss emerging novel biomarkers. There is a focus on the recent advances in the identification and validation of novel biomarkers, their potential applications in drug development and clinical practice, and the challenges and opportunities in translating these biomarkers into routine clinical use. Current gold-standard biomarkers: Alanine and aspartate aminotransferase activities perform well in diagnosing established drug-induced liver injury but may lack specificity and are not prognostic. The burden of proof for novel biomarkers: The amount of evidence required for a new biomarker will depend on its context-of-use, specifically on the impact on patient outcome of a false negative or false positive result. Leading potential biomarkers: Cytokeratin-18, glutamate dehydrogenase, microRNA-122, high-mobility group box 1 proteins, osteopontin, and macrophage colony-stimulating factor receptor 1 are examples of lead candidates. Potential applications of novel biomarkers: The early detection of drug-induced liver injury, interpretation of an alanine aminotransferase activity increase, and decisions about dose escalation in clinical trials may all be informed by new biomarkers. Conclusions: There have been numerous exploratory studies describing differences in biomarkers and their potential value in risk-stratifying populations or identifying specific patients who may be failed by current assessment protocols. Additionally, the use of exploratory biomarkers to guide clinical trial decision-making is becoming routine. The challenge is now clinically validating leading candidate biomarkers in the assessment of patients presenting with conditions such as paracetamol overdose, which place them at risk of acute liver injury. This will require robust clinical trials. If the use of these biomarkers is to be widely adopted, they will need to unequivocally demonstrate benefit in overall cost, morbidity or mortality.
MeSH term(s)	Humans ; Alanine Transaminase ; Biomarkers ; Liver/metabolism ; Prognosis ; Chemical and Drug Induced Liver Injury/diagnosis ; Chemical and Drug Induced Liver Injury/etiology ; MicroRNAs
Chemical Substances	Alanine Transaminase (EC 2.6.1.2) ; Biomarkers ; MIRN122 microRNA, human ; MicroRNAs
Language	English
Publishing date	2023-10-10
Publishing country	England
Document type	Journal Article
ZDB-ID	204476-6
ISSN	1556-9519 ; 0009-9309 ; 0731-3810 ; 1556-3650
ISSN (online)	1556-9519
ISSN	0009-9309 ; 0731-3810 ; 1556-3650
DOI	10.1080/15563650.2023.2259089
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Article ; Online: Gastrointestinal AEs seen in the POP trial due to SOD mimetic activity of calmangafodipir? - Authors' reply.

Dear, James W

EBioMedicine

2019 Volume 47, Page(s) 28

MeSH term(s)	Acetaminophen ; Acetylcysteine ; Edetic Acid/analogs & derivatives ; Humans ; Pyridoxal Phosphate/analogs & derivatives ; Superoxide Dismutase
Chemical Substances	Acetaminophen (362O9ITL9D) ; Pyridoxal Phosphate (5V5IOJ8338) ; Edetic Acid (9G34HU7RV0) ; Superoxide Dismutase (EC 1.15.1.1) ; N,N'-bis(pyridoxal-5-phosphate)ethylenediamine-N,N'-diacetic acid (P28BIW0UTB) ; Acetylcysteine (WYQ7N0BPYC)
Language	English
Publishing date	2019-09-03
Publishing country	Netherlands
Document type	Letter ; Comment
ZDB-ID	2851331-9
ISSN	2352-3964
ISSN (online)	2352-3964
DOI	10.1016/j.ebiom.2019.08.039
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Article ; Online: Paracetamol use in adults.

Caparrotta, Thomas M / Carduff, Emma / Dear, James W

BMJ (Clinical research ed.)

2023 Volume 383, Page(s) e070753

MeSH term(s)	Adult ; Humans ; Acetaminophen/therapeutic use ; Analgesics, Non-Narcotic/therapeutic use
Chemical Substances	Acetaminophen (362O9ITL9D) ; Analgesics, Non-Narcotic
Language	English
Publishing date	2023-11-16
Publishing country	England
Document type	Journal Article
ZDB-ID	1362901-3
ISSN	1756-1833 ; 0959-8154 ; 0959-8146 ; 0959-8138 ; 0959-535X ; 1759-2151
ISSN (online)	1756-1833
ISSN	0959-8154 ; 0959-8146 ; 0959-8138 ; 0959-535X ; 1759-2151
DOI	10.1136/bmj-2022-070753
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Article ; Online: New biomarkers for drug-induced liver injury.

Dear, James W

Hepatology (Baltimore, Md.)

2018 Volume 67, Issue 6, Page(s) 2480–2481

MeSH term(s)	Biomarkers ; Chemical and Drug Induced Liver Injury ; Humans ; Liver
Chemical Substances	Biomarkers
Language	English
Publishing date	2018-04-27
Publishing country	United States
Document type	Letter ; Comment
ZDB-ID	604603-4
ISSN	1527-3350 ; 0270-9139
ISSN (online)	1527-3350
ISSN	0270-9139
DOI	10.1002/hep.29865
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Article ; Online: Urinary Vesicles: Are They Ready for Real-World Use?

Hunter, Robert W / Dear, James W

Journal of the American Society of Nephrology : JASN

2021 Volume 32, Issue 5, Page(s) 1013–1015

MeSH term(s)	Nephrology ; Urinary Tract
Language	English
Publishing date	2021-03-29
Publishing country	United States
Document type	Editorial ; Research Support, Non-U.S. Gov't ; Comment
ZDB-ID	1085942-1
ISSN	1533-3450 ; 1046-6673
ISSN (online)	1533-3450
ISSN	1046-6673
DOI	10.1681/ASN.2021030332
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Article ; Online: Fifty years of paracetamol (acetaminophen) poisoning: the development of risk assessment and treatment 1973-2023 with particular focus on contributions published from Edinburgh and Denver.

Bateman, D Nicholas / Dart, Richard C / Dear, James W / Prescott, Laurie F / Rumack, Barry H

Clinical toxicology (Philadelphia, Pa.)

2024 Volume 61, Issue 12, Page(s) 1020–1031

Abstract: Introduction: Fifty years ago, basic scientific studies and the availability of assay methods made the assessment of risk in paracetamol (acetaminophen) poisoning possible. The use of the antidote acetylcysteine linked to new methods of risk assessment ... ...

Abstract	Introduction: Fifty years ago, basic scientific studies and the availability of assay methods made the assessment of risk in paracetamol (acetaminophen) poisoning possible. The use of the antidote acetylcysteine linked to new methods of risk assessment transformed the treatment of this poisoning. This review will describe the way in which risk assessment and treatments have developed over the last 50 years and highlight the remaining areas of uncertainty. Methods: A search of PubMed and its subsidiary databases revealed 1,166 references published in the period 1963-2023 using the combined terms "paracetamol", "poisoning", and "acetylcysteine". Focused searches then identified 170 papers dealing with risk assessment of paracetamol poisoning, 141 with adverse reactions to acetylcysteine and 114 describing different acetylcysteine regimens. To manage the extensive literature, we focused mainly on contributions made by the authors during their time in Edinburgh and Denver. Dose and concentration response: The key relationship between paracetamol dose and toxicity risk was established in 1971 and led to the development of the Rumack-Matthew nomogram from data collected in Edinburgh. Mechanisms of toxicity: A series of papers on the mechanisms of toxicity were published in 1973, and these showed that paracetamol hepatotoxicity was caused by the formation of a toxic intermediate epoxide metabolite normally detoxified by glutathione but which, in excess, was bound covalently to hepatic enzymes and proteins. An understanding of the relationship between the rate of paracetamol metabolism, paracetamol concentration, and toxic hazard in humans soon followed. Antidote development and efficacy in patients: These discoveries were followed by the testing of a range of sulfhydryl-donors in animals and "at risk" patients. Acetylcysteine was developed as the lead intravenous antidote in the United Kingdom. The license holder in the United States refused to make an intravenous formulation. Thus, oral acetylcysteine became the antidote trialed in the United States National Multicenter Study. Intravenous acetylcysteine regimens used initially in the United Kingdom and subsequently in the United States used loading doses of 150 mg/kg over 15 minutes or one hour, 50 mg/kg over four hours, and 100 mg/kg over 16 hours. These regimens were associated with adverse drug reactions (nausea, vomiting and anaphylactoid reactions) and hence, treatment interruption. Newer dosing regimens now give loading doses more slowly. One, the Scottish and Newcastle Anti-emetic Pretreatment protocol, using an acetylcysteine regimen of 100 mg/kg over two hours followed by 200 mg/kg over 10 hours, has been widely adopted in the United Kingdom. A cohort comparison study suggests this regimen has comparable efficacy to standard regimens and offers opportunities for selective higher acetylcysteine dosing. Risk assessment at presentation: No dose-ranging studies with acetylcysteine were done, and no placebo-controlled studies were performed. Thus, there is uncertainty regarding the optimal dose of acetylcysteine, particularly in patients ingesting very large overdoses of paracetamol. The choice of intervention concentration on the Rumack-Matthew nomogram has important consequences for the proportion of patients treated. The United States National Multicenter Study used a "treatment" line starting at 150 mg/L (992 µmol/L) at 4 hours post overdose, extending to 24 hours with a half-life of 4 hours, now standard there, and subsequently adopted in Australia and New Zealand. In the United Kingdom, the treatment line was initially 200 mg/L (1,323 µmol/L) at 4 hours (the Rumack-Matthew "risk" line). In 2012, the United Kingdom Medicines and Healthcare products Regulatory Agency lowered the treatment line to 100 mg/L (662 µmol/L) at 4 hours for all patients, increasing the number of patients admitted and treated at a high cost. Risk assessment is a key issue for ongoing study, particularly following the development of potential new antidotes that may act in those at greatest risk. The development of biomarkers to assess risk is ongoing but has yet to reach clinical trials. Conclusion: Even after 50 years, there are still areas of uncertainty. These include appropriate acetylcysteine doses in patients who ingest different paracetamol doses or multiple (staggered) ingestions, early identification of at-risk patients, and optimal treatment of late presenters.
MeSH term(s)	Humans ; Acetaminophen ; Antidotes/therapeutic use ; Acetylcysteine/therapeutic use ; Antiemetics/therapeutic use ; Risk Assessment ; Drug Overdose/diagnosis ; Drug Overdose/drug therapy ; Analgesics, Non-Narcotic ; Chemical and Drug Induced Liver Injury/diagnosis ; Chemical and Drug Induced Liver Injury/epidemiology ; Chemical and Drug Induced Liver Injury/etiology ; Multicenter Studies as Topic
Chemical Substances	Acetaminophen (362O9ITL9D) ; Antidotes ; Acetylcysteine (WYQ7N0BPYC) ; Antiemetics ; Analgesics, Non-Narcotic
Language	English
Publishing date	2024-01-25
Publishing country	England
Document type	Journal Article ; Review
ZDB-ID	204476-6
ISSN	1556-9519 ; 0009-9309 ; 0731-3810 ; 1556-3650
ISSN (online)	1556-9519
ISSN	0009-9309 ; 0731-3810 ; 1556-3650
DOI	10.1080/15563650.2023.2293452
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Article ; Online: Evaluation of capillary miR-122 as a prognostic biomarker of paracetamol-induced liver toxicity.

Cirronis, Marco / Schneemann, Sarah / Pettie, Janice / Mannaioni, Guido / Dear, James W

Molecular biology reports

2024 Volume 51, Issue 1, Page(s) 548

Abstract: Introduction: Paracetamol (acetaminophen) overdose is a leading cause of acute liver failure in many Western countries. Diagnostic tools for this poisoning may be suboptimal in some cases and new biomarkers have been investigated. We investigated the ... ...

Abstract	Introduction: Paracetamol (acetaminophen) overdose is a leading cause of acute liver failure in many Western countries. Diagnostic tools for this poisoning may be suboptimal in some cases and new biomarkers have been investigated. We investigated the role of capillary microRNA-122 (miR-122) as a prognostic biomarker of liver injury in the clinical management of patients with paracetamol overdose. Methods: In a paracetamol overdose patient cohort, miR-122 was measured by quantitative polymerase chain reaction in a blood drop obtained by a finger prick at the end of an antidote cycle treatment with N-acetylcysteine treatment (12 h). Liver injury was defined as serum alanine aminotransferase (ALT) activity > 100 IU/L collected at 10 or 20 h after the start of treatment. Pearson's correlation analyses were performed. Results: In patients with paracetamol overdose, capillary miR-122 was positively correlated with ALT measured at 10 h and at 20 h (r = 0.83, P < 0.0001; r = 0.96, P < 0.0001, respectively). Conclusion: This work supports the potential use of capillary miR-122 as a prognostic biomarker of liver injury throughout clinical management of patients with paracetamol overdose. Capillary miR-122 can be measured in a blood drop collected by a finger prick, a minimally invasive diagnostic test for patient stratification.
MeSH term(s)	Humans ; Acetaminophen/adverse effects ; Analgesics, Non-Narcotic ; Biomarkers ; Chemical and Drug Induced Liver Injury/diagnosis ; MicroRNAs/blood ; MicroRNAs/genetics ; Prognosis ; Chemical and Drug Induced Liver Injury, Chronic/diagnosis ; Chemical and Drug Induced Liver Injury, Chronic/genetics
Chemical Substances	Acetaminophen (362O9ITL9D) ; Analgesics, Non-Narcotic ; Biomarkers ; MicroRNAs ; MIRN122 microRNA, human
Language	English
Publishing date	2024-04-20
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	186544-4
ISSN	1573-4978 ; 0301-4851
ISSN (online)	1573-4978
ISSN	0301-4851
DOI	10.1007/s11033-024-09327-6
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Article: Proximity sensitive detection of microRNAs using electrochemical impedance spectroscopy biosensors

Roychoudhury, Appan / Dear, James W. / Bachmann, Till T.

Biosensors & bioelectronics. 2022 Sept. 15, v. 212

2022

Abstract: This study presents a new strategy and level of mechanistic understanding for ultrasensitive detection of short, non-coding RNAs without target amplification or chemical modification using electrochemical biosensors. Electrochemical impedance ... ...

Abstract	This study presents a new strategy and level of mechanistic understanding for ultrasensitive detection of short, non-coding RNAs without target amplification or chemical modification using electrochemical biosensors. Electrochemical impedance spectroscopy (EIS) has been used for probe target interaction detection because of its high utility for sensitive and label-free measurements of the nucleic acid targets as a result of hybridisation. EIS measurements of different probe target combinations in a range of spatial orientations and sequence overlaps showed that bringing the target overhangs closer to the nanometer proximity of the electrode surface improved the EIS signal significantly. Systematic investigations using different lengths of overhangs towards the electrode surface revealed proportionally higher EIS signals with increasing lengths of the overhangs. Our observations could be explained using the Poisson-Boltzmann and Gouy-Chapman model and followed our experimental modelling. In conclusion, the optimized arrangements of our EIS biosensor system enabled us to detect microRNA-122, a known biomarker for liver injury, as well as three common isoforms to a 1 nM (equivalent to 80 fmole) detection limit. This will enable us to develop solutions for the detection of this important blood biomarker at point of care.
Keywords	biomarkers ; biosensors ; blood ; detection limit ; dielectric spectroscopy ; electrodes ; liver ; microRNA ; models ; point-of-care systems
Language	English
Dates of publication	2022-0915
Publishing place	Elsevier B.V.
Document type	Article
ZDB-ID	1011023-9
ISSN	1873-4235 ; 0956-5663
ISSN (online)	1873-4235
ISSN	0956-5663
DOI	10.1016/j.bios.2022.114404
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