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• W2742832130 abstract "Nonsteroidal anti-inflammatory drugs (NSAIDs) are responsible for 3% to 10% of idiosyncratic drug-induced liver injury (DILI) cases in the Western world.1Lucena M.I. Andrade R.J. Kaplowitz N. et al.Phenotypic characterization of idiosyncratic drug-induced liver injury: the influence of age and sex.Hepatology. 2009; 49: 2001-2009Google Scholar, 2Björnsson E.S. Bergmann O.M. Björnsson H.K. et al.Incidence, presentation, and outcomes in patients with drug-induced liver injury in the general population of Iceland.Gastroenterology. 2013; 144: 1419-1425Google Scholar, 3Chalasani N. Bonkovsky H.L. Fontana R. et al.Features and outcomes of 899 patients with drug-induced liver injury: the DILIN prospective study.Gastroenterology. 2015; 148: 1340-1352Google Scholar Ibuprofen is a widely prescribed NSAID available as over-the-counter medication (OTC), and perceived as having a better safety profile than many other NSAIDs. Interestingly, striking regional differences in the frequency of ibuprofen hepatotoxicity were noted in a comparison of causative DILI agents among large DILI cohorts in 2010.4Suzuki A. Andrade R.J. Björnsson E. et al.Drugs associated with hepatotoxicity and their reporting frequency of liver adverse events in VigiBase: unified list based on international collaborative work.Drug Saf. 2010; 33: 503-522Google Scholar Based on the limited information available on this type of DILI, we aimed to analyze the clinical presentation of ibuprofen-associated hepatotoxicity in the search for a potential drug signature. Twenty-one ibuprofen-induced idiosyncratic hepatotoxicity cases from the Spanish DILI Registry and 5 cases included in the Latin DILI Network were analyzed and compared with 76 idiosyncratic hepatotoxicity events resulting from other NSAIDs and 844 non–NSAID-induced hepatotoxicity cases from the same databases. Only cases induced by conventional medications were included in the current study. All NSAID cases were limited to cases in which the NSAID was judged as a single-culprit drug. Ibuprofen was the most frequent causative drug (29%) among the 73 NSAID DILI cases in the Spanish DILI Registry, followed by diclofenac (18%). Among the 29 Latin-American NSAID hepatotoxicity cases, nimesulide (38%) predominated, followed by diclofenac (34%) and ibuprofen (17%). Demographics and clinical features, including liver injury pattern and laboratory parameters, did not differ between the 26 ibuprofen DILI patients and those induced by other NSAIDs or non-NSAIDs (Table 1). Hypertension was less prevalent among the ibuprofen cases (10% vs 20%–29%), whereas diabetes was significantly more frequent (27% vs 7%–12%; P = .04). Despite not being statistically significant, the ibuprofen cases contained a higher proportion of fatal/liver transplant patients (12% vs 3%–5%) than the other 2 groups.Table 1Comparison of Demographic, Clinical, and Laboratory Parameters Between Hepatotoxicity Cases Induced by Ibuprofen, Other NSAIDs and Non-NSAID DrugsIbuprofen (N = 26)Other NSAIDs (N = 76)Non-NSAIDs (N = 844)P valueDemographic data Female, n (%)13 (50)43 (57)434 (51).7 Age, y, mean (range)51 (18–77)55 (16–82)55 (11–90).4 Age >60 y, n (%)7 (27)33 (43)366 (43).8 BMI, kg/m2, mean (range)28 (23–36)26 (20–36)26 (16–59).06Clinical presentation, n (%) Jaundice17 (65)53 (71)557 (67).8 Hospital admission14 (58)37 (52)443 (52).9 Eosinophilia6 (24)13 (18)200 (25).4 Lymphopenia4 (17)13 (19)151 (21).8 Positive autoantibodies titers6 (27)17 (26)166 (24).9 Treatment duration, d, median (range)16 (1–1826)30 (3–550)29 (1–3724).2 Time to onset, d, median (range)15 (3–1767)27.5 (3–466)27 (1–2313).2Underlying diseases, n (%) Hypertension2 (10)12 (20)187 (29).06 Diabetes mellitus7 (27)6 (8)103 (12).04Type of liver injury, n (%) Hepatocellular15 (58)51 (67)499 (61).5 Cholestatic/mixed11 (42)25 (33)319 (39)Severity, n (%) Mild9 (35)25 (33)263 (31)1.0 Moderate14 (54)40 (53)464 (55) Severe–6 (8)63 (7) Fatal/liver transplantation2/1 (12)2/2 (5)19/13 (3)Biochemical parameters at onset, mean ×ULN (range) TBL, mg/dL5.7 (0.4–26)7.3 (0.6–34)7.0 (0.2–46).8 AST14 (0.9–50)18 (1.3–134)15 (0.2–180).7 ALT18 (1.0–68)21 (1.2–98)18 (0.3–203).1 GGT9.5 (0.5–43)8.3 (0.3–47)8.3 (0.2–79).7 ALP2.3 (0.8–7.1)2.1 (0.2–8.1)2.3 (0.3–22).6 Cases fulfilling Hy's law criteria, n (%)11 (42)30 (39)276 (33).3Outcome, n (%) Cases resolved in ≤1 y from onset, n (%)11 (85)(N = 13)38 (88)(N = 43)358 (86) (N = 418).9NOTE. Percentages shown were calculated based on the total number of episodes with available information.ALP, alkaline phosphatase; ALT, alanine aminotransferase; AST, aspartate aminotransferase; BMI, body mass index; GGT, γ-glutamyl transferase; TBL, serum total bilirubin; ULN, upper limit of normal. Open table in a new tab NOTE. Percentages shown were calculated based on the total number of episodes with available information. ALP, alkaline phosphatase; ALT, alanine aminotransferase; AST, aspartate aminotransferase; BMI, body mass index; GGT, γ-glutamyl transferase; TBL, serum total bilirubin; ULN, upper limit of normal. Ibuprofen has traditionally been considered to have very limited hepatotoxicity potential. However, a considerably higher prevalence of ibuprofen DILI cases was noted in the Spanish DILI Registry compared with previous reports from the United States and Iceland.2Björnsson E.S. Bergmann O.M. Björnsson H.K. et al.Incidence, presentation, and outcomes in patients with drug-induced liver injury in the general population of Iceland.Gastroenterology. 2013; 144: 1419-1425Google Scholar, 5Schmeltzer P.A. Kosinski A.S. Kleiner D.E. et al.Liver injury from nonsteroidal anti-inflammatory drugs in the United States.Liver Int. 2016; 36: 603-609Google Scholar The commercialized oral doses of ibuprofen available for OTC use in Spain are 200 and 400 mg. In the United States, OTC ibuprofen is available only at 200 mg. The fact that ibuprofen consumers in Spain have access to higher OTC doses raises the question of whether the difference in ibuprofen DILI frequency seen between the Spanish and US DILI registries could be related to dosage. It is believed that a threshold drug dose, which may vary between individuals, needs to be exceeded for idiosyncratic DILI to occur. Thus, larger drug doses could increase drug biotransformation rates and trigger excess reactive metabolite formation. As a result, generation of oxidative stress may lead to cellular injury by activating cell death–related signaling pathways. In fact, increased expression of c-Jun N-terminal kinases has recently been demonstrated in liver tissue of DILI patients.6Cubero F.J. Zoubek M.E. Hu W. et al.Combined activities of JNK1 and JNK2 in hepatocytes protect against toxic liver injury.Gastroenterology. 2016; 150: 968-981Google Scholar Hence, one might hypothesize that higher available OTC dose formulation is more likely to induce a cellular injury process that may lead to ibuprofen DILI in susceptible individuals. A recent multicenter study in Italy reported a higher adjusted risk of liver damage for ibuprofen than for diclofenac.7Donati M. Conforti A. Capuano A. et al.Risk of acute and serious liver injury associated to nimesulide and other NSAIDs: data from drug-induced liver injury case-control study in Italy.Br J Clin Pharmacol. 2016; 82: 238-248Google Scholar It is interesting to note that ibuprofen also is available as a 400-mg OTC formulation in Italy. Nevertheless, genetic differences and variations in pattern of drug use also may contribute to differential ibuprofen DILI frequencies. Our study did not show a characteristic drug signature for ibuprofen DILI compared with other causative agents. Although generally developing within 4 weeks from treatment initiation and presenting as a hepatocellular type of liver damage, the characteristics of ibuprofen hepatotoxicity varied considerably between susceptible patients. This most likely reflects the contribution of host and environmental factors in DILI presentation.8Chen M. Suzuki A. Borlak J. et al.Drug-induced liver injury: interactions between drug properties and host factors.J Hepatol. 2015; 63: 503-514Google Scholar We detected a trend toward diabetes mellitus being more common in patients with ibuprofen DILI. The implication of this finding is yet to be understood. Diabetes as a general DILI risk factor lacks supportive evidence. Furthermore, diabetic patients are advised to use ibuprofen at the lowest recommended dose for short durations to avoid further alteration of renal homeostasis. We also detected a lower prevalence of hypertension in the ibuprofen cases. This is likely the consequence of ibuprofen as well as many other NSAIDs being issued with a special warning in patients with hypertension because they can attenuate the effects of antihypertensive agents. In conclusion, the risk of developing ibuprofen-induced liver injury is low considering the extensive use of this drug worldwide, but should not be overlooked as it can have life-threatening consequences. The absence of a distinct drug signature highlights the contribution of individual host and environmental factors in ibuprofen DILI." @default.
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• W2742832130 date "2018-02-01" @default.
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• W2742832130 title "High Prevalence of Ibuprofen Drug-Induced Liver Injury in Spanish and Latin-American Registries" @default.
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