Table 2.
Frequency Counts (n, %) of Treatment Emergent Symptomsa
During the 1-week Medication Titration Period (Days 1 – 8).
| Adverse Event | Placebo (n=20) |
1 mg/day Varenicline (n=20) |
2 mg/day Varenicline (n=20) |
|---|---|---|---|
| Constipation | 0, 0% | 1, 5% | 2, 10% |
| Nausea/Vomiting | 6, 30% | 4, 20% | 5, 25% |
| Dry Mouth* | 7, 35% | 2, 10% | 2, 10% |
| Insomnia* | 2, 10% | 0, 0% | 5, 25% |
| Flatulence | 1, 5% | 0, 0% | 1, 5% |
| Difficulty Breathing | 0, 0% | 1, 5% | 1, 5% |
| Shortness of Breath | 1, 5% | 0, 0% | 1, 5% |
| Tightness in Chest | 0, 0% | 1, 5% | 0, 0% |
| Abnormal Dreams | 2, 10% | 1, 5% | 3, 15% |
| Fast Heartbeat | 1, 5% | 1, 5% | 3, 15% |
| Suicidal Thoughts | 0, 0% | 0, 0% | 0, 0% |
| Erratic Behavior | 0, 0% | 0, 0% | 0, 0% |
a
More than 5% and twice the rate seen in placebo-treated subjects.
Note: Frequency counts differed for dry mouth and insomnia (*p<.05).
Severity ratings wereall minimal or mild and didnot differ across medication groups.