Table 3.
Meta-analysis of suicide-related events in acute paediatric active comparator-controlled atomoxetine studies–ADHD (FDA-defined approach)
| |
Atomoxetine |
Methylphenidate |
MHRRa(95% CI) p-value |
MHIDb(%) (95% CI) p-value |
||||
|---|---|---|---|---|---|---|---|---|
| Outcome | No. of events | N | % | No. of events | N | % | ||
| Code 1,2,3,4: suicidal behaviour or ideation |
1 |
559 |
0.18 |
1 |
465 |
0.22 |
0.52 (95% CI; 0.06, 4.54) P = 0.556 |
-0.12 (-0.62, 0.38) P = 0.649 |
| Code 4: Suicidal ideation |
1 |
559 |
0.18 |
1 |
465 |
0.22 |
0.52 (95% CI; 0.06, 4.54) P = 0.556 |
-0.12 (-0.62, 0.38) P = 0.649 |
| Code 1,2,3,4,5,6,9: possible suicidal behaviour or ideation | 3 | 559 | 0.54 | 2 | 465 | 0.43 | 0.62 (95% CI; 0.14, 2.73) P = 0.528 | -0.14 (-0.88, 0.60) P = 0.713 |
aMHRR Mantel-Haenszel risk ratio stratified by study. It is the estimate of the percentage among atomoxetine-treated patients over the percentage among methylphenidate-treated patients.
bMHID Mantel-Haenszel incidence difference stratified by study. It is the estimate of the percentage among atomoxetine-treated patients minus the percentage among methylphenidate-treated patients in percentage units.