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Table 5 IRs, IRRs, and 95 % confidence intervals of hepatic events without identified alternate etiology, follow-up through 15 days following treatment discontinuation, matched duloxetine and comparator cohorts, ORD, 01 August 2004 to 31 December 2010

From: Hepatic outcomes among adults taking duloxetine: a retrospective cohort study in a US health care claims database

Outcome Cohort Person-Years No. Cases IR 95 CI % IRR 95 % CI
Hepatic-related death Duloxetine 7633.5 0 0.0 (0.0, 0.4) NA NA
Venlafaxine 8838.7 0 0.0 (0.0, 0.3)   
Duloxetine 10,411.9 0 0.0 (0.0, 0.3) NA NA
SSRI 9835.6 0 0.0 (0.0, 0.3)   
Duloxetine 8116.7 0 0.0 (0.0, 0.4) NA NA
Untreated 5966.1 0 0.0 (0.0, 0.5)   
Hepatic failure Duloxetine 7631.7 0 0.0 (0.0, 0.4) NA NA
Venlafaxine 8836.6 0 0.0 (0.0, 0.3)   
Duloxetine 10,410.6 0 0.0 (0.0, 0.3) NA NA
SSRI 9833.9 0 0.0 (0.0, 0.3)   
Duloxetine 8116.2 0 0.0 (0.0, 0.4) NA NA
Untreated 5965.8 0 0.0 (0.0, 0.5)   
Other clinically significant hepatic injurya Duloxetine 7548.5 5 0.7 (0.2, 1.5) undef. (1.1, inf.)
Venlafaxine 8745.2 0 0.0 (0.0, 0.3)   
Duloxetine 10,300.9 4 0.4 (0.1, 1.0) undef. (0.6, inf.)
SSRI 9753.2 0 0.0 (0.0, 0.3)   
Duloxetine 8035.8 4 0.5 (0.1, 1.3) 1.0 (0.2, 6.7)
Untreated 5931.9 3 0.5 (0.1, 1.5)   
Hepatic-related death and liver failure combined Duloxetine 7631.7 0 0.0 (0.0, 0.4) NA NA
Venlafaxine 8836.6 0 0.0 (0.0, 0.3)   
Duloxetine 10,410.6 0 0.0 (0.0, 0.3) NA NA
SSRI 9833.8 0 0.0 (0.0, 0.3)   
Duloxetine 8116.2 0 0.0 (0.0,0.4) NA NA
Untreated 5965.6 0 0.0 (0.0, 0.5)   
All clinically significant hepatic categories combined Duloxetine 7548.5 5 0.7 (0.2, 1.5) undef. (1.1, inf.)
Venlafaxine 8745.2 0 0.0 (0.0, 0.3)   
Duloxetine 10,300.9 4 0.4 (0.1, 1.0) undef. (0.6, inf.)
SSRI 9753.2 0 0.0 (0.0, 0.3)   
Duloxetine 8035.8 4 0.5 (0.1, 1.3) 1.0 (0.2, 6.7)
Untreated 5931.9 3 0.5 (0.1, 1.5)   
Non-serious hepatic enzyme elevation Duloxetine 7548.5 1 0.1 (0.0, 0.7) undef. (0.0, inf.)
Venlafaxine 8745.2 0 0.0 (0.0,0.3)   
Duloxetine 10,300.9 1 0.1 (0.0, 0.5) 0.5 (0.0, 9.1)
SSRI 9753.0 2 0.2 (0.0, 0.7)   
Duloxetine 8035.8 1 0.1 (0.0, 0.7) undef. (0.0, inf.)
Untreated 5932.0 0 0.0 (0.0, 0.5)   
  1. ORD Optum Research Database, IR incidence rate, representing number of events per 1000 person-years, CI confidence interval, IRR incidence rate ratio, NA not available, undef.undefined, inf. infinity
  2. aOne case of other clinically significant hepatic injury in the duloxetine cohort was initially confirmed by independent adjudicators as a confirmed case without alternate etiology. However, following a post hoc review by the adjudicators, this case was classified as a hepatic injury with alternate etiologies. Because we conducted this post hoc review outside of the protocol, the case remains in these data as a confirmed case without alternate etiology