Table 4.
Summary of Peto odds ratios, risk differences, and 95% confidence intervals for neuropsychiatric events in people treated with varenicline
| Neuropsychiatric adverse event | No of events/No treated | Odds ratio (95% CI), P value | Risk difference (95% CI), P value | |
|---|---|---|---|---|
| Varenicline group | Placebo group | |||
| Primary outcomes | ||||
| Depression | 163/5356 | 139/4487 | 0.96 (0.75 to 1.22), 0.74 | −0.001 (−0.01 to 0.01), 0.74 |
| Suicidal ideation | 15/2799 | 18/2191 | 0.58 (0.28 to 1.20), 0.14 | −0.003 (−0.009 to 0.002), 0.24 |
| Attempted suicide | 2/2184 | 2/1842 | 0.75 (0.10 to 5.65), 0.78 | −0.0003 (−0.005 to 0.004), 0.91 |
| Suicide and attempted suicide | 4/5352 | 2/4478 | 1.67 (0.33 to 8.57), 0.54 | 0.0003 (−0.002 to 0.003), 0.81 |
| Secondary outcomes | ||||
| Abnormal dreams | 603/5606 | 224/4741 | 2.38 (2.05 to 2.77), <0.001 | 0.06 (0.05 to 0.07), <0.001 |
| Aggression | 39/4276 | 24/3524 | 0.91 (0.52 to 1.59), 0.75 | −0.001 (−0.005 to 0.004), 0.79 |
| Anxiety | 209/4999 | 226/4457 | 0.75 (0.61 to 0.93), 0.008 | −0.01 (−0.02 to -0.0003), 0.01 |
| Death | 13/5760 | 11/4887 | 1.05 (0.47 to 2.38), 0.9 | 0.0001 (−0.003 to 0.003), 0.94 |
| Fatigue | 283/5502 | 202/4701 | 1.28 (1.06 to 1.55), 0.01 | 0.01 (0.002 to 0.02), 0.01 |
| Insomnia | 679/5621 | 379/4762 | 1.56 (1.36 to 1.78), <0.001 | 0.04 (0.03 to 0.05), <0.001 |
| Irritability | 293/5406 | 266/4615 | 0.98 (0.81 to 1.17), 0.79 | −0.001 (−0.01 to 0.008), 0.79 |
| Sleep disorders | 211/5081 | 123/4284 | 1.63 (1.29 to 2.07), <0.001 | 0.02 (0.01 to 0.02), <0.001 |
| Somnolence | 139/5360 | 91/4542 | 1.23 (0.94 to 1.62), 0.13 | 0.005 (−0.001 to 0.01), 0.13 |