Study type

Study topic

Disease /health condition
Human medicinal product

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

Anatomical Therapeutic Chemical (ATC) code

(N06AX21) duloxetine
duloxetine

Medical condition to be studied

Drug-induced liver injury
Population studied

Short description of the study population

Adults (18+ years of age) who: initiated at least one study antidepressant (duloxetine, venlafaxine, or SSRI) between 01 August 2004 and 31 September 2010, or who had a diagnosis of depression without an antidepressant medication; were members of a commercial health plan that allows access to medical records for research purposes, with complete medical coverage and pharmacy benefits; met 12 months prior continuous enrollment criteria, and had a claim for diagnosis of depression during the 12-month baseline period.

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

30844
Study design details

Main study objective

to estimate the absolute and relative incidence of clinically significanthepatic events among patients with depression who initiated duloxetine relative to each of 3 propensity score-matched comparison cohorts.

Outcomes

Clinically significant hepatic injury (hepatic-related death, liverfailure, other clinically significant hepatic injury,hepatic-related death or liver failure combined, and allclinically significant hepatic categories combined). non-serious asymptomatic hepatic enzyme elevation

Data analysis plan

We matched duloxetine initiators to each of the 3 comparator cohorts (venlafaxine, SSRI, untreated) using a multivariable technique (propensity score analysis and matching) that can achieve a high degree of balance between comparison groups. Incidence rates were calculated as the number of cases divided by the relevant person-time. We also estimated 95% confidenceintervals (CIs) of the IRs for the duloxetine initiator and comparator cohorts. Rate ratios (RR) and associated 95% CIs were estimated for duloxetine initiators compared with each of the 3 propensity score-matched comparator cohorts.