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Article
Open AccessCorrection to: Drug-Induced Liver Injury in the Elderly: Consensus Statements and Recommendations from the IQ-DILI Initiative
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Open AccessDrug-Induced Liver Injury in the Elderly: Consensus Statements and Recommendations from the IQ-DILI Initiative
The elderly demographic is the fastest-growing segment of the world’s population and is projected to exceed 1.5 billion people by 2050. With multimorbidity, polypharmacy, susceptibility to drug–drug interactio...
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Article
Open AccessConsensus Guidelines: Best Practices for the Prevention, Detection and Management of Hepatitis B Virus Reactivation in Clinical Trials with Immunosuppressive/Immunomodulatory Therapy
Hepatitis B virus reactivation (HBVr) during and after immunosuppressive/immunomodulatory (IS/IM) therapy is associated with significant morbidity and mortality, including hepatic decompensation and acute live...
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Article
Open AccessThe Metreleptin Effectiveness and Safety Registry (MEASuRE): concept, design and challenges
Metreleptin, a recombinant analog of human leptin, is an approved therapy, adjunct to diet, to treat the metabolic complications of leptin deficiency in patients with lipodystrophy – a group of rare diseases c...
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Drug-Induced Liver Injury: Highlights and Controversies in the Recent Literature
Drug-induced liver injury (DILI) remains an important, yet challenging diagnosis for physicians. Each year, additional drugs are implicated in DILI and this year was no different, with more than 1400 articles ...
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Open AccessConsensus Guidelines: Best Practices for Detection, Assessment and Management of Suspected Acute Drug-Induced Liver Injury During Clinical Trials in Adults with Chronic Viral Hepatitis and Adults with Cirrhosis Secondary to Hepatitis B, C and Nonalcoholic Steatohepatitis
With the widespread development of new drugs to treat chronic liver diseases (CLDs), including viral hepatitis and nonalcoholic steatohepatitis (NASH), more patients are entering trials with abnormal baseline ...
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Open AccessReal-world safety of palbociclib in breast cancer patients in the United States: a new user cohort study
There is limited real-world safety information on palbociclib for treatment of advanced stage HR+/HER2- breast cancer.
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Article
Open AccessOnapristone Extended Release: Safety Evaluation from Phase I–II Studies with an Emphasis on Hepatotoxicity
Antiprogestins have demonstrated promising activity against breast and gynecological cancers, but liver-related safety concerns limited the advancement of this therapeutic class. Onapristone is a full progeste...
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Hepatotoxicty of Agents Used in the Management of Inflammatory Bowel Disease: a 2020 Update
As treatment options for inflammatory bowel disease (IBD) continue to expand, the opportunity for hepatotoxicity remains a clinical concern. This review looks to update the current literature on drug-induced l...
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Significant Variation in the Detection Rates of Proximal Serrated Polyps Among Academic Gastroenterologists, Community Gastroenterologists, and Colorectal Surgeons in a Single Tertiary Care Center
Recent studies have demonstrated that the protective effect of colonoscopy against colorectal cancer is lower in the proximal colon. Proximal serrated polyps, including sessile serrated adenomas and proximal h...
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Article
Drug-Induced Liver Injury: Highlights of the Recent Literature
Drug-induced liver injury (DILI), herbal-induced liver injury, and herbal and dietary supplement (HDS)-induced liver injury are an important aspect of drug safety. Knowledge regarding responsible drugs, mechan...
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Disorders of the Liver Excluding Hepatitis A, B, C, D, and E
Liver disease is one of the most common non-AIDS-related causes of death in HIV-infected patients, but the incidence may be declining with advances in antiretroviral therapy (Jennifer and Thio, Clin Gastroente...
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Drug-Induced Liver Injury: Highlights from a Review of the 2015 Literature
Numerous publications contributed to the expanding knowledge base about drug-induced liver injury (DILI) in 2015. New findings from the US Drug Induced Liver Injury Network (DILIN) in their most recently updat...
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Open AccessEnoxaparin-Induced Liver Injury: Case Report and Review of the Literature and FDA Adverse Event Reporting System (FAERS)
Anticoagulants are a well known cause of drug-induced liver injury (DILI). We recently encountered a 45-year-old male who developed DILI during treatment with enoxaparin, a low-molecular-weight heparin (LMWH),...
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Open AccessClinical Pattern of Tolvaptan-Associated Liver Injury in Subjects with Autosomal Dominant Polycystic Kidney Disease: Analysis of Clinical Trials Database
Subjects with autosomal dominant polycystic kidney disease (ADPKD) who were taking tolvaptan experienced aminotransferase elevations more frequently than those on placebo in the TEMPO 3:4 (Tolvaptan Efficacy a...
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Hepatic Decompensation Likely Attributable to Simeprevir in Patients with Advanced Cirrhosis
Hyperbilirubinemia is a common side effect of protease inhibitors used to treat chronic hepatitis C (HCV), and most patients do not experience without clinically overt hepatotoxicity. The safety of second-wave...
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Open AccessLiver Safety Assessment: Required Data Elements and Best Practices for Data Collection and Standardization in Clinical Trials
A workshop was convened to discuss best practices for the assessment of drug-induced liver injury (DILI) in clinical trials. In a breakout session, workshop attendees discussed necessary data elements and stan...
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Prescribing a Statin to a Cirrhotic Patient to Reduce Hepatic Decompensation and Improve Survival: Impossible You Say?
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Sumatriptan-Associated Ischemic Colitis: Case report and Review of the Literature and FAERS
Ischemic colitis (IC) is being increasingly recognized, although specific etiological causes are observed in a minority of patients. While several drugs have been associated with IC, most remain anecdotal repo...
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Polypharmacy and Comorbidity Are Associated with a Lower Early Virologic Response in Hepatitis C Patients Treated with First Generation Protease Inhibitor Triple Therapy: A Preliminary Analysis
The protease inhibitors (PIs) boceprevir and telaprevir are currently standard treatment as part of triple therapy regimens (TTx) for chronic HCV genotype 1 (GT1) patients. In this preliminary analysis, we hav...
