O-37 amoxicillin-clavulanate induced liver injury: ten years experience from latindili registry.

Introduction and Objectives: Although amoxicillin-clavulanate combination (ACC) is a well-established cause of liver injury, clinicians are unaware of some aspects that explain why its diagnosis may be initially missed, making the patient susceptible to unnecessary exploration or treatment. This study aimed to describe DILI characteristics linked to ACC in the LATINDILI registry. Materials and Methods: We revised data concerning DILI-ACC in the LATINDILI registry during the last decade, looking for information on latency, pattern, severity, and evolution. Baseline characteristics were described using mean, median, and percentages; Student's t-test or a chi-squared test was used to determine the difference between mean and frequencies. A P-value of less than 0.05 was considered statistical significance. Results: We identified 61 DILI-ACC episodes in 60 patients from the LATINDILI registry. The mean age was 58 years (19-90 y), and 54% were male. Median latency was 21 days, with median ALT and ALP at DILI onset of 282 U/L (range 34-2130) and 585 U/L (range 96-1626), respectively; a cholestatic/mixed pattern predominated in 43 cases. In 53 cases, the liver injury appeared with a mean of 13 days (range 2-39 d) after treatment ended. Twenty patients (33%) had allergic immune features, 79% were jaundiced, and 61% required hospitalization. The mean total bilirubin values increased by 7.5 mg/dl (1.5-16) from the onset in 24 of 42 evaluable patients after ten days (range 2-30). Table 1 shows the comparison between groups. Resolution of liver injury occurred on average 64 (14-270) days, one patient did not normalize after 365 days, and no death was consigned. Conclusions: Jaundice linked to a cholestatic/mixed pattern appearing after stopping therapy was a frequent presentation of ACC in our analysis. This clinical presentation may be missed when using ACC and explaining the delayed diagnosis. Worsening bilirubin value is frequent and may be related to longer treatment duration and prolonged latency.