Table 3.
Adverse Eventsa
| No. (%) |
|||
|---|---|---|---|
| Adverse Events | Varenicline + Bupropion SR (n = 249) |
Varenicline + Placebo (n = 257) |
P Valueb |
| Sleep disturbance | 100 (40.2) | 91 (35.4) | .273 |
| Nausea | 55 (22.1) | 54 (21.0) | .829 |
| Constipation | 26 (10.4) | 19 (7.4) | .275 |
| Headache | 21 (8.4) | 22 (8.6) | >.99 |
| Irritability | 21 (8.4) | 12 (4.7) | .105 |
| Abnormal dreams | 9 (3.6) | 19 (7.4) | .080 |
| Anxiety | 18 (7.2) | 8 (3.1) | .044 |
| Difficulty concentrating | 14 (5.6) | 10 (3.9) | .407 |
| Fatigue | 7 (2.8) | 17 (6.6) | .058 |
| Dizziness | 10 (4.0) | 10 (3.9) | >.99 |
| Mood disturbance | 13 (5.2) | 7 (2.7) | .175 |
| Dry mouth | 7 (2.8) | 9 (3.5) | .801 |
| Restlessness | 9 (3.6) | 5 (1.9) | .288 |
| Depressive symptoms | 9 (3.6) | 2 (0.8) | .034 |
| Flatulence | 1 (0.4) | 9 (3.5) | .020 |
| Dyspepsia | 5 (2.0) | 1 (0.4) | .117 |
Abbreviation: SR, sustained-release.
a
Adverse events considered to be possibly, probably, or definitely related to study medication and reported by ≥ 2% of either study group are summarized.
b
Fisher exact test.