Serious adverse events by treatment group
| Serious adverse events from baseline to week 52 | No. (%) of participants | Risk difference (95% CI) | |
|---|---|---|---|
| Varenicline n = 151 | Placebo n = 151 | ||
| Any serious adverse event* | 37 (24.5)† | 33 (21.9)‡ | 2.7 (−7.3 to 12.6) |
| Composite major adverse cardiovascular events (cardiovascular death, MI, unstable angina) | 13 (8.6) | 14 (9.3) | −0.7 (−7.8 to 6.5) |
| Cardiovascular death | 2 (1.3) | 0 | 1.3 (−2.0 to 5.2) |
| MI | 8 (5.3) | 9 (6.0) | −0.7 (−6.7 to 5.4) |
| Unstable angina | 4 (2.6) | 6 (4.0) | −1.3 (−6.5 to 3.7) |
| Other cardiovascular event | 6 (4.0) | 3 (2.0) | 2.0 (−2.8 to 7.1) |
| Noncardiovascular death | 1 (0.7) | 0 | 0.7 (−2.5 to 4.2) |
| Neuropsychiatric event | |||
| Seizure | 0 | 0 | 0.0 (−3.1 to 3.1) |
| Suicidal ideation | 1 (0.7) | 0 | 0.7 (−2.5 to 4.2) |
| Other neuropsychiatric event | 1 (0.7) | 0 | 0.7 (−2.5 to 4.2) |
| Other | 19 (12.6) | 17 (11.3) | 1.3 (−6.6 to 9.3) |
Note: CI = confidence interval, MI = myocardial infarction.
↵* Only the first event for each participant in each category was counted (i.e., the numbers represent the number of patients experiencing an event in each category, rather than the absolute number of events).
↵† 37 patients in the varenicline arm experienced a total of 49 serious adverse events, with 8 patients experiencing more than 1 event.
↵‡ 33 patients in the placebo arm experienced a total of 44 serious adverse events, with 9 patients experiencing more than 1 event.