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Hepatotoxic Medication

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1. Using Clinical Laboratory Tests to Monitor Drug Therapy in Pain Management Patients

Using Clinical Laboratory Tests to Monitor Drug Therapy in Pain Management Patients LABORATORY MEDICINE PRACTICE GUIDELINES EDITED BY LORALIE J. LANGMAN AND PAUL J. JANNETTO Using Clinical Laboratory Tests to Monitor Drug Therapy in Pain Management Patients Co-Sponsored byLABORATORY MEDICINE PRACTICE GUIDELINES Using Clinical Laboratory Tests to Monitor Drug Therapy in Pain Management Patients Loralie J. Langman Committee Chair Department of Laboratory Medicine and Pathology Mayo Clinic (...) References 101 Table of ContentsLABORATORY MEDICINE PRACTICE GUIDELINES Using Clinical Laboratory Tests to Monitor Drug Therapy in Pain Management Patients 5 Executive Summary Introduction The American Association for Clinical Chemistry (AACC) Acad- emy, formerly the National Academy of Clinical Biochemistry (NACB), has developed a laboratory medicine practice guidelines (LMPG) for using laboratory tests to monitor drug therapy in pain management patients. The scope and purpose of this guideline

2018 American Academy of Pain Medicine

2. Drug Therapy for Early Rheumatoid Arthritis: A Systematic Review Update

Drug Therapy for Early Rheumatoid Arthritis: A Systematic Review Update PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE Drug Therapy for Early Rheumatoid Arthritis: A Systematic Review Update July 2018 In partnership withComparative Effectiveness Review Number 211 Drug Therapy for Early Rheumatoid Arthritis: A Systematic Review Update Prepared for: Agency for Healthcare Research and Quality U.S. Department of Health and Human Services 5600 Fishers Lane Rockville, MD 20857 www.ahrq.gov and Patient (...) at: www.effectivehealthcare.ahrq.gov. Search on the title of the report. Persons using assistive technology may not be able to fully access information in this report. For assistance contact epc@ahrq.hhs.gov. Suggested citation: Donahue KE, Gartlehner G, Schulman ER, Jonas B, Coker-Schwimmer E, Patel SV, Weber RP, Lohr KN, Bann C, Viswanathan M. Drug Therapy for Early Rheumatoid Arthritis: A Systematic Review Update. Comparative Effectiveness Review No. 211. (Prepared by the RTI International–University of North Carolina

2018 Effective Health Care Program (AHRQ)

3. Evaluation of Adverse Drug Reaction Profile of Drugs Used as First-Line Antiretroviral Therapy Full Text available with Trip Pro

Evaluation of Adverse Drug Reaction Profile of Drugs Used as First-Line Antiretroviral Therapy The objective was to study the adverse drug reaction (ADR) profile in HIV patients receiving first-line antiretroviral therapy.This was a prospective, observational study that included 171 HIV patients with a follow-up at six months. Demographic details, medical history, details of HIV infection including most recent CD4 count, details of antiretroviral therapy, and other concomitant medication were (...) recorded. Adverse drug reactions were elicited by reviewing patient records and also by interviewing the patient/attendants directly.171 patients completed the study out of which 88 (51.5%) were males and 83 (48.5%) were females. The study subjects included HIV-positive, treatment naïve patients who were started on treatment regimens recommended by the NACO guidelines. The ADRs observed were a fall in haemoglobin or absolute anaemia in response to zidovudine, nonspecific symptoms like headache

2018 Interdisciplinary perspectives on infectious diseases

4. Antituberculosis Drug-Induced Liver Injury in Children: Incidence and Risk Factors During the Two-Month Intensive Phase of Therapy. (Abstract)

with first-line anti-TB drugs were prospectively followed-up for the development of ATLI. Liver function tests were performed at baseline and after 2 weeks of therapy. Subsequent tests were conducted at 4, 6 and 8 weeks if the initial 2-week measurement was abnormal or if symptoms of hepatotoxicity were reported.ATLI was detected in 11 (27%) patients within 14 to 42 days from the start of therapy, with most of them (54%) occurred after 2 weeks. TB treatment was stopped immediately in 6 of 11 patients who (...) Antituberculosis Drug-Induced Liver Injury in Children: Incidence and Risk Factors During the Two-Month Intensive Phase of Therapy. As one of the most frequent and serious adverse reactions during tuberculosis (TB) treatment, antituberculosis drug-induced liver injury (ATLI) in children has been studied insufficiently compared with adults. We aimed to determine the incidence and risk factors of ATLI in children during the first 2 months of TB therapy.A total of 41 children with TB and treated

2018 Pediatric Infectious Dsease Journal

5. Liver injury is most commonly due to hepatic metastases rather than drug hepatotoxicity during pembrolizumab immunotherapy. Full Text available with Trip Pro

patients treated with pembrolizumab who develop liver injury experience poorer outcomes during follow-up. The low incidence of confirmed drug hepatotoxicity highlights the need for thorough medical evaluation before initiating corticosteroids to optimise patient care.© 2019 John Wiley & Sons Ltd. (...) Liver injury is most commonly due to hepatic metastases rather than drug hepatotoxicity during pembrolizumab immunotherapy. Pembrolizumab immunotherapy has been associated with hepatotoxicity in 1%-10% of oncology patients treated in clinical trials.To describe the incidence, phenotypes and outcomes of liver injury in a large cohort of solid organ tumour patients receiving pembrolizumab METHODS: Liver injury was defined by serum alanine aminotransferase, alkaline phosphatase, and/or total

2019 Alimentary Pharmacology & Therapeutics

6. Synergistic Cytotoxicity from Drugs and Cytokines In Vitro as an Approach to Classify Drugs According to Their Potential to Cause Idiosyncratic Hepatotoxicity: A Proof-of-Concept Study Full Text available with Trip Pro

Synergistic Cytotoxicity from Drugs and Cytokines In Vitro as an Approach to Classify Drugs According to Their Potential to Cause Idiosyncratic Hepatotoxicity: A Proof-of-Concept Study Idiosyncratic drug-induced liver injury (IDILI) typically occurs in a small fraction of patients and has resulted in removal of otherwise efficacious drugs from the market. Current preclinical testing methods are ineffective in predicting which drug candidates have IDILI liability. Recent results suggest (...) that immune mediators such as tumor necrosis factor-α (TNF) and interferon-γ (IFN) interact with drugs that cause IDILI to kill hepatocytes. This proof-of-concept study was designed to test the hypothesis that drugs can be classified according to their ability to cause IDILI in humans using classification modeling with covariates derived from concentration-response relationships that describe cytotoxic interaction with cytokines. Human hepatoma (HepG2) cells were treated with drugs associated with IDILI

2017 The Journal of pharmacology and experimental therapeutics

7. Evaluation of the Potential Risk of Drugs to Induce Hepatotoxicity in Human—Relationships between Hepatic Steatosis Observed in Non-Clinical Toxicity Study and Hepatotoxicity in Humans- Full Text available with Trip Pro

Evaluation of the Potential Risk of Drugs to Induce Hepatotoxicity in Human—Relationships between Hepatic Steatosis Observed in Non-Clinical Toxicity Study and Hepatotoxicity in Humans- In the development of drugs, we sometimes encounter fatty change of the hepatocytes (steatosis) which is not accompanied by degenerative change in the liver in non-clinical toxicity studies. In this study, we investigated the relationships between fatty change of the hepatocytes noted in non-clinical toxicity (...) studies of compound X, a candidate compound in drug development, and mitochondrial dysfunction in order to estimate the potential risk of the compound to induce drug-induced liver injury (DILI) in humans. We conducted in vivo and in vitro exploratory studies for this purpose. In vivo lipidomics analysis was conducted to investigate the relationships between alteration of the hepatic lipids and mitochondrial dysfunction. In the liver of rats treated with compound X, triglycerides containing long-chain

2017 International journal of molecular sciences

8. Hepatotoxicity During Isoniazid Preventive Therapy and Antiretroviral Therapy in People Living With HIV With Severe Immunosuppression: A Secondary Analysis of a Multi-Country Open-Label Randomized Controlled Clinical Trial. Full Text available with Trip Pro

Hepatotoxicity During Isoniazid Preventive Therapy and Antiretroviral Therapy in People Living With HIV With Severe Immunosuppression: A Secondary Analysis of a Multi-Country Open-Label Randomized Controlled Clinical Trial. Hepatotoxicity associated with isoniazid preventive therapy (IPT) and antiretroviral therapy (ART) has not been well studied in severely immunosuppressed people with HIV. Our objective was to determine risk factors for hepatotoxicity in severely immunosuppressed individuals (...) taking IPT and ART.Multicenter study in resource-limited settings with high burden of tuberculosis.We conducted a secondary analysis of data from 1 randomized arm of the REMEMBER trial. The analysis includes participants with pre-ART CD4 cell counts of <50 cells/μL receiving IPT and ART for 24 weeks. Hepatotoxicity was defined as elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >5 × upper limit of normal or symptomatic hepatitis during IPT and ART. Logistic regression

2018 Journal of acquired immune deficiency syndromes (1999) Controlled trial quality: predicted high

9. Hepatoprotective Evaluation of Trapa natans against Drug-induced Hepatotoxicity of Antitubercular Agents in Rats Full Text available with Trip Pro

Hepatoprotective Evaluation of Trapa natans against Drug-induced Hepatotoxicity of Antitubercular Agents in Rats Medicinal herbs are significantly effective against a variety of liver disorders and Trapa natans was traditionally used for the treatment of anti-inflammatory, pain disorder, and various types of hepatic ailment.The purpose of this study was to evaluate the hepatoprotective activity of T. natans fruit peel extract against antitubercular drugs (isoniazid + rifampicin [INH + RIF (...) and 400 mg/kg) resulted in significant (P < 0.01 to P< 0.001) reduction in liver marker enzymes and antioxidant parametersThus, it can be concluded that Trapa natans fruit peel extract showed hepatoprotective potential against antitubercular drugs induced hepatotoxicity. Abbreviations used: INH: Isoniazid; RIF: Rifampicin; DIH: Drug-induced hepatotoxicity; CMC: Carboxy methyl cellulose; ALT: Alanine transaminase; ALP: Alkaline phosphate; CHL: Total cholesterol; ALB: Albumin; LDH: Lactate dehydrogenase

2018 Pharmacognosy magazine

10. Protective Effects of Eugenol against Hepatotoxicity Induced by Arsenic Trioxide: An Antileukemic Drug Full Text available with Trip Pro

Protective Effects of Eugenol against Hepatotoxicity Induced by Arsenic Trioxide: An Antileukemic Drug Arsenic trioxide (As2O3) has shown effectiveness in the treatment of leukemia, but it is also associated with hepatotoxicity. Given antileukemic drug-induced oxidative stress and toxicity, this study focused on the mitigatory role of eugenol, a monoterpene compound from clove oil, in the hepatic tissue of Wistar rats.Twenty-four male Wistar rats (180-250 g) were randomly divided into 4 groups

2018 Iranian journal of medical sciences

11. p53 attenuates acetaminophen-induced hepatotoxicity by regulating drug-metabolizing enzymes and transporter expression Full Text available with Trip Pro

p53 attenuates acetaminophen-induced hepatotoxicity by regulating drug-metabolizing enzymes and transporter expression Acetaminophen (APAP) overdose is the most frequent cause of drug-induced acute liver failure. Inhibition of APAP metabolic activation and promotion in APAP disposition are important to protect against APAP-induced liver injury. Tumor suppressor p53 is traditionally recognized as a surveillance molecule to preserve genome integrity. Recent studies have emerged on discovering its (...) hepatotoxicity. Dox treatment prevented APAP-induced GSH depletion and lipid peroxidation. p53-null mice were more susceptible to APAP-induced liver injury. Further, we found that the expression of drug-metabolizing enzymes and transporters CYPs, SULTs and MRPs was regulated by p53. Dox treatment also promoted Nrf2 activation and increased the expression of Nrf2 target genes including GSTα/μ and NQO1, which contribute to APAP detoxification. Overall, this study is the first to demonstrate the protective role

2018 Cell death & disease

12. Prediction of Drug-Induced Hepatotoxicity Using Long-Term Stable Primary Hepatic 3D Spheroid Cultures in Chemically Defined Conditions Full Text available with Trip Pro

Prediction of Drug-Induced Hepatotoxicity Using Long-Term Stable Primary Hepatic 3D Spheroid Cultures in Chemically Defined Conditions High failure rates of drug candidates in the clinics, restricted-use warnings as well as withdrawals of drugs in postmarketing stages are of substantial concern for the pharmaceutical industry and drug-induced liver injury (DILI) constitutes one of the most frequent reasons for such safety failures. Importantly, as DILI cannot be accurately predicted using (...) . Therefore, we here evaluated the hepatotoxicity of 123 drugs with or without direct implication in clinical DILI events. Importantly, using ATP quantifications as the single endpoint, the model accurately distinguished between hepatotoxic and nontoxic structural analogues and exceeded both sensitivity and specificity of all previously published in vitro assays at substantially lower exposure levels, successfully detecting 69% of all hepatotoxic compounds without producing any false positive results (100

2018 Toxicological Sciences

13. Oxidative Stress and First-Line Antituberculosis Drug-Induced Hepatotoxicity. Full Text available with Trip Pro

pathogenetic mechanism(s) for liver injury might be in operation due to disease-drug interaction. Our current ability to predict, prevent, or treat hepatotoxicity (other than removing potentially hepatotoxic drugs) remains limited. More translational research to unravel the pathogenesis, inclusive of the underlying molecular bases, regarding antituberculosis drug-induced hepatotoxicity is needed, and so is clinical research pertaining to the advances in therapy, with antioxidants and beyond. The role (...) Oxidative Stress and First-Line Antituberculosis Drug-Induced Hepatotoxicity. Hepatotoxicity induced by antituberculosis drugs is a serious adverse reaction with significant morbidity and even, rarely, mortality. This form of toxicity potentially impacts the treatment outcome of tuberculosis in some patients. Covering only first-line antituberculosis drugs, this review addresses whether and how oxidative stress and, more broadly, disturbance in redox homeostasis alongside mitochondrial

2018 Antimicrobial Agents and Chemotherapy

14. Real-life study of safety of thiopurine-allopurinol combination therapy in inflammatory bowel disease: myelotoxicity and hepatotoxicity rarely affect maintenance treatment. (Abstract)

Real-life study of safety of thiopurine-allopurinol combination therapy in inflammatory bowel disease: myelotoxicity and hepatotoxicity rarely affect maintenance treatment. Low-dose thiopurine-allopurinol (LDTA) combination therapy is a commonly applied optimisation strategy in IBD patients with a skewed thiopurine metabolism.To assess continued LDTA maintenance treatment at annual intervals and explore risk factors for treatment cessation METHODS: Adult IBD patients treated with LDTA between (...) 2009 and 2016 were retrospectively included. Data on the incidence of clinical and laboratory adverse events (AEs), including hepatotoxicity and myelotoxicity resulting in imposing LDTA therapy cessation and associated risk factors were collected.In total, 221 IBD patients (46% male, median age 42 years) were included. Maintenance LDTA treatment was continued in 78% of patients at 1 year (n = 145), 66% at 2 years (n = 83), 57% at 3 years (n = 52) and 52% at 4 years (n = 33). Treatment in patients

2019 Alimentary Pharmacology & Therapeutics

15. Intensive Medical Therapy for High-risk Intracranial or Extracranial Arterial Stenosis

Intensive Medical Therapy for High-risk Intracranial or Extracranial Arterial Stenosis Intensive Medical Therapy for High-risk Intracranial or Extracranial Arterial Stenosis - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies (...) before adding more. Intensive Medical Therapy for High-risk Intracranial or Extracranial Arterial Stenosis (INSPIRES) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. of clinical studies and talk to your health care provider before participating. Read our for details. ClinicalTrials.gov Identifier: NCT03635749 Recruitment Status : Not yet recruiting First

2018 Clinical Trials

16. Brief Report: Increased Hepatotoxicity Associated with Sequential Immune Checkpoint Inhibitor and Crizotinib Therapy in Patients with Non-Small-Cell Lung Cancer. Full Text available with Trip Pro

Brief Report: Increased Hepatotoxicity Associated with Sequential Immune Checkpoint Inhibitor and Crizotinib Therapy in Patients with Non-Small-Cell Lung Cancer. Immune checkpoint inhibitors (ICIs) are standard therapies in advanced NSCLC. Although genotype-directed tyrosine kinase inhibitors represent the standard of care for subsets of oncogene-driven NSCLC, patients may receive ICIs during their disease course. The impact of sequential ICI and tyrosine kinase inhibitor therapy on the risk (...) of hepatotoxicity has not been described.Patients with advanced ALK receptor tyrosine kinase (ALK)-driven, ROS1-driven, or MET proto-oncogene, receptor tyrosine kinase (MET)-driven NSCLC treated with crizotinib, with or without preceding ICI therapy, were identified. The cumulative incidences of crizotinib-associated grade 3 or higher increases in transaminase level (per the Common Terminology Criteria for Adverse Events, version 4.0) were compared.We identified 453 patients who had NSCLC with an oncogenic

2018 Journal of Thoracic Oncology

17. Serious hepatotoxicity following use of isoniazid preventive therapy in HIV patients in Eritrea Full Text available with Trip Pro

Serious hepatotoxicity following use of isoniazid preventive therapy in HIV patients in Eritrea WHO information note indicates that isoniazid preventive therapy (IPT) is generally safe with little risk of hepatotoxicity. However, when the policy of IPT for HIV patients was introduced in Eritrea, frequent IPT-associated hepatotoxicity and fatality have been reported to the Pharmacovigilance Centre. The aim of the study is to assess the causal association of IPT and hepatotoxicity and identify (...) possible risk factors in patients on Highly Active Anti-retroviral Therapy (HAART). This is a case series assessment of spontaneously reported cases to the Eritrean Pharmacovigilance Centre. Data extracted from VigiFlow (reported between 2014 and 2016) were exported to excel spread sheet for descriptive and qualitative analysis. Naranjo probability scale and Austin Bradford-Hill criteria were used to assess causality. The P-Method was used to assess preventability. A total of 31 of cases

2018 Pharmacology research & perspectives

18. Hepatotoxicity in hyperthyroid patient after consecutive methimazole and propylthiouracil therapies Full Text available with Trip Pro

Hepatotoxicity in hyperthyroid patient after consecutive methimazole and propylthiouracil therapies Methimazole (MMI) and propylthiouracil (PTU) are widely used antithyroid drugs (ATD) that have been approved for the treatment of hyperthyroidism. Hepatotoxicity may be induced by these drugs, though they exert dissimilar incidence rates of hepatotoxicity and, possibly, with different underlying pathogenic mechanisms. We report the case of a 55-year-old woman with no relevant medical history

2018 Endocrinology, diabetes & metabolism case reports

19. Efficacy Versus Hepatotoxicity of High-dose Rifampin, Pyrazinamide, and Moxifloxacin to Shorten Tuberculosis Therapy Duration: There Is Still Fight in the Old Warriors Yet! Full Text available with Trip Pro

Efficacy Versus Hepatotoxicity of High-dose Rifampin, Pyrazinamide, and Moxifloxacin to Shorten Tuberculosis Therapy Duration: There Is Still Fight in the Old Warriors Yet! One approach that could increase the efficacy and reduce the duration of antituberculosis therapy is pharmacokinetics/pharmacodynamics-based optimization of doses. However, this could increase toxicity.We mimicked the concentration-time profiles achieved by human equivalent doses of moxifloxacin 800 mg/day, rifampin 1800 mg (...) /day, and pyrazinamide 4000 mg/day (high-dose regimen) vs isoniazid 300 mg/day, rifampin 600 mg/day, and pyrazinamide 2000 mg/day (standard therapy) in bactericidal and sterilizing effect studies in the hollow fiber system model of tuberculosis (HFS-TB). In an intracellular Mycobacterium tuberculosis (Mtb) HFS-TB experiment, we added a 3-dimensional human organotypic liver to determine potential hepatotoxicity of the high-dose regimen, based on lactate dehydrogenase (LDH). Treatment lasted 28 days

2018 Clinical Infectious Diseases

20. A Comparative Analysis of Drug-Induced Hepatotoxicity in Clinically Relevant Situations Full Text available with Trip Pro

A Comparative Analysis of Drug-Induced Hepatotoxicity in Clinically Relevant Situations Drug-induced toxicity is a significant problem in clinical care. A key problem here is a general understanding of the molecular mechanisms accompanying the transition from desired drug effects to adverse events following administration of either therapeutic or toxic doses, in particular within a patient context. Here, a comparative toxicity analysis was performed for fifteen hepatotoxic drugs by evaluating (...) toxic changes reflecting the transition from therapeutic drug responses to toxic reactions at the cellular level. By use of physiologically-based pharmacokinetic modeling, in vitro toxicity data were first contextualized to quantitatively describe time-resolved drug responses within a patient context. Comparatively studying toxic changes across the considered hepatotoxicants allowed the identification of subsets of drugs sharing similar perturbations on key cellular processes, functional classes

2017 PLoS computational biology

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