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
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) | |||