Probable drug-induced liver injury associated with aliskiren: case report and review of adverse event reports from pharmacovigilance databases
| Autor: | Louis Merle, Sabrina Crépin, Paul Carrier, Claire Villeneuve, Marie-Laure Laroche, Bertrand Godet |
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| Přispěvatelé: | Service de Pharmacologie, toxicologie et pharmacovigilance [CHU Limoges], CHU Limoges, Université de Limoges (UNILIM), Handicap, Activité, Vieillissement, Autonomie, Environnement (HAVAE), Institut Génomique, Environnement, Immunité, Santé, Thérapeutique (GEIST), Université de Limoges (UNILIM)-Université de Limoges (UNILIM) |
| Rok vydání: | 2014 |
| Předmět: |
Databases
Factual Aspartate transaminase computer.software_genre Asymptomatic digestive system chemistry.chemical_compound Pharmacovigilance Fumarates Liver Function Tests Medicine Humans Aspartate Aminotransferases Adverse effect Antihypertensive Agents Pharmacology Liver injury Database medicine.diagnostic_test biology business.industry Health Policy Alanine Transaminase Aliskiren Middle Aged medicine.disease Amides digestive system diseases 3. Good health chemistry Alanine transaminase Acute Disease biology.protein Female Liver function medicine.symptom Chemical and Drug Induced Liver Injury business Liver function tests computer [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology |
| Zdroj: | American Journal of Health-System Pharmacy American Journal of Health-System Pharmacy, American Society of Health-System Pharmacists, 2014, 71 (8), pp.643-7. ⟨10.2146/ajhp130149⟩ |
| ISSN: | 1535-2900 1079-2082 |
| DOI: | 10.2146/ajhp130149⟩ |
| Popis: | International audience; PURPOSE: A case of probable drug-induced liver injury (DILI) attributed to use of the antihypertensive agent aliskiren is reported. SUMMARY: A 61-year-old woman undergoing routine liver function monitoring in conjunction with long-term antiepileptic therapy was noted to have an asymptomatic acute hepatic cytolysis 1 month after the initiation of concomitant aliskiren therapy (150 mg/day). Liver enzyme testing showed dramatically elevated aspartate transaminase (AST) and alanine transaminase (ALT) concentrations, with substantial rises also noted in γ-glutamyltransferase (GGT) and alkaline phosphatase (ALP) levels. The calculated ALT:ALP value indicated hepatocellular injury. On discontinuation of aliskiren use, rapid biological improvement occurred, including normalization of serum AST and a sharp decline in serum ALT within one week and the return of GGT and ALP levels to baseline a few weeks later; the patient's AST and ALT concentrations remained normal during 18 months of subsequent monitoring. Using the algorithm of Naranjo et al. and a DILI-specific causality assessment instrument, it was determined that aliskiren use was the probable cause of the patient's liver injury. While this is believed to be the first report of aliskiren-associated DILI in the professional literature, a review of information from several European and North American pharmacovigilance databases (through October 2012) identified 117 reports of suspected aliskiren hepatotoxicity, including 6 reports of liver failure and 12 reports of deaths. CONCLUSION: Asymptomatic acute hepatic cytolysis was observed in a 61-year-old woman approximately one month after initiation of aliskerin for treatment of hypertension. Improvement in AST and ALT concentrations was observed shortly after the drug was discontinued. |
| Databáze: | OpenAIRE |
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