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Table 6 IRs, IRRs, and 95 % confidence intervals of hepatic events irrespective of determination of 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 injury Duloxetine 7548.5 11 1.5 (0.7, 2.6) 3.2 (0.9, 13.7)
Venlafaxine 8745.2 4 0.5 (0.1, 1.2)   
Duloxetine 10,300.9 14 1.4 (0.7, 2.3) 1.3 (0.5, 3.3)
SSRI 9753.2 10 1.0 (0.5,1.9)   
Duloxetine 8035.8 11 1.4 (0.7, 2.4) 1.0 (0.4, 2.9)
  Untreated 5931.9 8 1.3 (0.6, 2.7)   
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 11 1.5 (0.7, 2.6) 3.2 (0.9, 13.7)
Venlafaxine 8745.2 4 0.5 (0.1, 1.2)   
Duloxetine 10,300.9 14 1.4 (0.7, 2.3) 1.3 (0.5, 3.3)
SSRI 9753.2 10 1.0 (0.5, 1.9)   
Duloxetine 8035.8 11 1.4 (0.7, 2.4) 1.0 (0.4, 2.9)
  Untreated 5931.9 8 1.3 (0.6, 2.7)   
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) 0.7 (0.0,57.9)
  Untreated 5932.0 1 0.2 (0.0, 0.9)   
  1. ORD Optum Research Database, IR incidence rate, representing number of events per 1000 person-years, CI confidence interval, IRR: rate ratio, NA not available, undef. undefined, inf. infinity