Table 1 Summary of efficacy and adverse event outcomes in duloxetine trials
| Â | Â | Number of | Percent with | Â | Â | ||
|---|---|---|---|---|---|---|---|
Outcome | Dose (daily maximum) | Trials | Patients | Duloxetine | Placebo | Relative benefit or risk (95% CI) | NNT/NNTp/NNH(95% CI) |
Efficacy | |||||||
50% PR All | 20/60/120 mg | 6 | 2,216 | 41 | 24 | 1.7 (1.4 to 1.9) | 5.9 (4.8 to 7.7) |
50% PR PDN | 60/120 mg | 3 | 1,024 | 47 | 27 | 1.7 (1.4 to 2.1) | 5.1 (3.9 to 7.3) |
50% PR fibromyalgia | 60/120 mg | 3 | 996 | 37 | 21 | 1.7 (1.4 to 2.1) | 6.4 (4.7 to 9.9) |
50% PR | 60 mg | 5 | 1,211 | 43 | 26 | 1.7 (1.4 to 2.0) | 5.8 (4.4 to 8.4) |
50% PR | 120 mg | 6 | 1,410 | 42 | 24 | 1.7 (1.5 to 2.0) | 5.7 (4.5 to 7.8) |
Adverse events general | |||||||
Withdrawal – all cause | 20/60/120 mg | 6 | 2,418 | 30 | 26 | 1.2 (1.1 to 1.4) | 26 (13 to 426) |
Withdrawal – LoE | 20/60/120 mg | 5 | 1,872 | 4 | 9 | 0.5 (0.4 to 0.7) | 20 (13 to 42) |
Withdrawal – AE | 20/60/120 mg | 6 | 2,220 | 15 | 8 | 1.8 (1.4 to 2.4) | 15 (11 to 25) |
Any AE | 60/120 mg | 4 | 1,243 | 82 | 67 | 1.2 (1.2 to 1.3) | 6.7 (5.0 to 10) |
Serious AE | 60/120 mg | 3 | 1,034 | 2 | 3 | 0.8 (0.4 to 1.7) | not calculated |
Specific adverse events | |||||||
Nausea | 20/60/120 mg | 3 | 1,145 | 29 | 10 | 3.0 (2.2 to 4.3) | 5.3 (4.3 to 6.9) |
Somnolence | 20/60/120 mg | 3 | 1,145 | 14 | 4 | 2.9 (1.7 to 4.9) | 11 (8.0 to 16) |
Constipation | 20/60/120 mg | 3 | 1,145 | 13 | 3 | 3.6 (2.0 to 6.5) | 11 (8.3 to 16) |
Decreased appetite | 20/60/120 mg | 2 | 811 | 7 | 1 | 4.9 (1.7 to 14) | 18 (12 to 34) |