The Indian Network of Drug-Induced Liver Injury: Etiology, Clinical Features, Outcome and Prognostic Markers in 1288 Patients.
J Clin Exp Hepatol
; 11(3): 288-298, 2021.
Article
en En
| MEDLINE
| ID: mdl-33994711
ABSTRACT
BACKGROUND:
Etiology of and outcomes following idiosyncratic drug-induced liver injury (DILI) vary geographically. We conducted a prospective study of DILI in India, from 2013 to 2018 and summarize the causes, clinical features, outcomes and predictors of mortality.METHODS:
We enrolled patients with DILI using international DILI expert working group criteria and Roussel Uclaf causality assessment method. Follow-up was up to 3 months from onset of DILI or until death. Multivariate logistics regression was carried out to determine predictors of non-survival.RESULTS:
Among 1288 patients with idiosyncratic DILI, 51.4% were male, 68% developed jaundice, 68% required hospitalization and 8.2% had co-existing HIV infection. Concomitant features of skin reaction, ascites, and encephalopathy (HE) were seen in 19.5%, 16.4%, and 10% respectively. 32.4% had severe disease. Mean MELD score at presentation was 18.8 ± 8.8. Overall mortality was 12.3%; 65% in those with HE, 17.6% in patients who fulfilled Hy's law, and 16.6% in those that developed jaundice. Combination anti-TB drugs (ATD) 46.4%, complementary and alternative medicines (CAM) 13.9%, anti-epileptic drugs (AED) 8.1%, non-ATD antimicrobials 6.5%, anti-metabolites 3.8%, anti-retroviral drugs (ART)3.5%, NSAID2.6%, hormones 2.5%, and statins 1.4% were the top 9 causes. Univariate analysis identified, ascites, HE, serum albumin, bilirubin, creatinine, INR, MELD score (p < 0.001), transaminases (p < 0.04), and anti-TB drugs (p = 0.02) as predictors of non-survival. Only serum creatinine (p = 0.017), INR (p < 0.001), HE (p < 0.001), and ascites (p = 0.008), were significantly associated with mortality on multivariate analysis. ROC yielded a C-statistic of 0.811 for MELD and 0.892 for combination of serum creatinine, INR, ascites and HE. More than 50 different agents were associated with DILI. Mortality varied by drug class 15% with ATD, 13.6% with CAM, 15.5% with AED, 5.8% with antibiotics.CONCLUSION:
In India, ATD, CAM, AED, anti-metabolites and ART account for the majority of cases of DILI. The 3-month mortality was approximately 12%. Hy's law, presence of jaundice or MELD were predictors of mortality.
AED, Anti-epileptic drugs; ALF, Acute liver failure; ALT, Alanine aminotransferase; ART, Anti-retroviral drugs; AST, Aspartate aminotransferase; ATD, Anti- tuberculosis drugs; Anti-tuberculosis drugs; C.I, Confidence interval; CAM, Complementary and alternative medicine; Complimentary medicines; DILI, Drug-induced liver injury; DILIN, Drug induced liver injury network; HE, Hepatic encephalopathy; HIV, Human immunodeficiency virus; INR, International normalised ratio; Isoniazid; Jaundice; MELD, Model for end stage liver disease; Mortality; NSAID, Nonsteroidal anti-inflammatory drugs; OR, Odds ratio; Prognosis; Pyrazinamide; ROC, Receiver operating characteristic; RUCAM, Roussel uclaf causality assessment method; Rifampicin; TB, Tuberculosis.; TCM, Traditional chinese medicines.; Traditional medicines; ULN, Upper limit of normal; USA, United states of america
Texto completo:
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Bases de datos:
MEDLINE
Tipo de estudio:
Etiology_studies
/
Observational_studies
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Prognostic_studies
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Risk_factors_studies
Idioma:
En
Revista:
J Clin Exp Hepatol
Año:
2021
Tipo del documento:
Article
País de afiliación:
India