Study type

Study topic

Human medicinal product
Disease /health condition

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness

Data collection methods

Secondary use of data
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Name of medicine

ECALTA

Medical condition to be studied

Hepatotoxicity
Population studied

Short description of the study population

Patients admitted to a hospital, with 1 dose of echinocandin antifungal medicines, and aged 18 and above at hospitalization admission.

Age groups

  • Adult and elderly population (≥18 years)
    • Adults (18 to < 65 years)
      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 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

12678
Study design details

Main study objective

The primary objective of the study was to estimate the risk of severe hepatotoxicity associated with exposure to echinocandins, and to compare the risk of severe hepatotoxicity in hospitalized patients treated with anidulafungin to that of hospitalized patients treated with other echinocandins (caspofungin and micafungin) in a real‑world setting.

Outcomes

First severe hepatotoxicity event in the observation period. Severe hepatotoxicity was ascertained based on the first LFT of Grades 3, 4, or 5 in the observation period. For this study, the definition of the LFT grades was adapted from the CIT-TCAE, Version 5.0, modified standards from National Cancer Institute, Common Terminology Criteria for Adverse Events.

Data analysis plan

The risks were evaluated in the forms of absolute risk (i.e. cumulative incidence) and incidence rate. The risk ratios were evaluated in the forms of relative risk and incidence rate ratio.The null hypotheses tested were that the risk of severe hepatotoxicity in hospitalized patients treated with anidulafungin was not statistically different from that in hospitalized patients treated with caspofungin or micafungin.