Hepatic Outcomes Among Adults Taking Duloxetine in a US Health Care Claims Database (F1J-MC-B037)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/20329
• EU PAS number:
  EUPAS7584
• Study ID:
  20329
• Official title and acronym:
  Hepatic Outcomes Among Adults Taking Duloxetine in a US Health Care Claims Database (F1J-MC-B037)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  We conducted a retrospective matched cohort study toevaluate the association of clinically significant hepaticinjury and exposure to duloxetine, with specificdefinitional and methodological enhancements to focuson potential drug-related associations. The primarystudy objective was to estimate the absolute and relativeincidence of clinically significant hepatic events(hepatic-related death, liver failure, other clinicallysignificant liver injury, hepatic-related death and liverfailure combined, all clinically significant hepatic injurycategories combined) among patients with depressionwho initiated duloxetine relative to each of 3 propensityscore-matched comparison cohorts: patients withdepression who initiated venlafaxine, patients withdepression who initiated SSRIs, and patients with adiagnosis of depression who did not receive treatment.Secondary objectives addressed a range of potentialalternative explanations for the observed results (e.g.,residual confounding).
• Study status:
  Finalised

Research institutions and networks

Institutions

Optum

Germany

Study timelines

Date when funding contract was signed

Planned: 01/04/2010

Actual: 07/12/2012

Study start date

Planned: 01/04/2010

Actual: 07/12/2012

Date of final study report

Planned: 01/05/2013

Actual: 20/09/2013

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Eli Lilly and Company

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)