EPIHAM: Drug-induced liver injury leading to hospital admission: a study in national healthcare insurance databases

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Secondary data collection

Non-interventional study

• Non-interventional study design:
  Case-control

  Case-only

  Cohort

  Other
• Non-interventional study design, other:
  Case-crossover analysis

Study drug and medical condition

• Medical condition to be studied:
  Acute hepatic failure

Population studied

• Short description of the study population:
  Patients admitted with a primary diagnosis of acute toxic liver injury.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Hepatic impaired
• Estimated number of subjects:
  4800000

Study design details

• Main study objective:
  To identify the main drugs associated with DILIH in France and the event rates associated with DILIH, for individual drugs and for drug families, in terms of absolute and relative risks
• Data analysis plan:
  Descriptive: For categorical and ordinal variables will provide the number and the frequency of each modality as well as missing data. For quantitative variables will provide mean, standard deviation, first quartile, median, third quartile, and extreme values. Case-population: The main study analysis. Number of cases exposed to a given drug is compared to the number of subjects using the drug within the study time-frame, or to the number of defined daily doses (DDD) dispensed in the database population. Case-crossover: One or more control periods will be selected, one year before ID to take into account possible seasonal variations in drug use, or randomly within the year previous to ID. Case-control: Within the database population, controls will be selected, matched on age, gender, concomitant chronic diseases. Cohort: If events are enough, incident user cohorts and controls, adjusted or matched on propensity scores will be built and followed using cox proportional hazards analyses.

Documents

Study results

EPIHAM-1-Rapport final IReSP-V1.0-20170131

Study publications

Gulmez SE, Unal US, Lassalle R, Chartier A, Grolleau A, Moore N. Risk of hospit…

Moore N, Duret S, Grolleau A, Lassalle R, Barbet V, Duong M, Thurin N, Droz-Per…