Overview of previous studies on cardiovascular and neuropsychiatric events in users of varenicline and bupropion
| Author (year of publication) | Study type | Exposure | Outcome | Incidence of events per 1000 patients per year | Relative event rates* (95% CIs) |
|---|---|---|---|---|---|
| Svanström (2012)29 | Retrospective cohort study using national patient registry | Varenicline vs. bupropion | Cardiovascular event (acute coronary syndrome, ischaemic stroke, or cardiovascular death) | Varenicline: 6.9, bupropion: 7.1 | HR=0.96 (0.67 to 1.39) |
| Acute coronary syndrome | Varenicline: 4.7, bupropion: 3.9 | HR=1.20 (0.75 to 1.91) | |||
| Ischaemic stroke | Varenicline: 1.9, bupropion: 2.5 | HR=0.77 (0.40 to 1.48) | |||
| Cardiovascular death | Varenicline: 0.4, bupropion: 0.7 | HR=0.51 (0.13 to 2.02) | |||
| Prochaska (2012)26 | Meta-analysis of 14 randomised controlled trials | Varenicline vs. placebo | Cardiovascular serious adverse event (myocardial infarction, unstable angina, coronary revascularisation, coronary artery disease, arrhythmias, transient ischaemic attacks, stroke, sudden death or cardiovascular-related death, or congestive heart failure) | Not reported | RR=1.40 (0.82 to 2.39) |
| Singh (2011)18 | Meta-analysis of 14 randomised controlled trials | Varenicline vs. placebo | Cardiovascular event (ischemia, arrhythmia, congestive heart failure, sudden death or cardiovascular-related death) | Varenicline: 10.6, placebo: 8.2 | OR=1.72 (1.09 to 2.71) |
| Thomas (2013)28 | Retrospective cohort study using GP database | Varenicline vs NRT Bupropion vs. NRT | Fatal or non-fatal self-harm | Varenicline: 2.6, bupropion: 2.5, NRT: 3.6 | HR=0.88 (0.52 to 1.49)HR=0.83 (0.30 to 2.31) |
| Varenicline vs NRT Bupropion vs NRT | Treated depression | Varenicline: 57.5, bupropion: 41.6, NRT: 77.5 | HR=0.75 (0.65 to 0.87)HR=0.63 (0.46 to 0.87) | ||
| Pasternak (2013)27 | Retrospective cohort study using national patient registry | Psychiatric adverse event (emergency department visit or in-patient admission with a psychiatric diagnosis) | Not reported | HR=0.85 (0.55 to 1.30) | |
| Meyer (2013)31 | Retrospective cohort study using a military health system claims database | Varenicline vs. NRT | ICD-9 coded diagnosis of schizophrenia, non-organic psychoses, suicide attempt, or drug-induced/transient mental-, mood-, delusional-, anxiety-, personality-, post-traumatic- or depressive disorders. | Varenicline: 18.1, NRT: 15.8 | HR=1.14 (0.56 to 2.34) |
| Buggy (2013)30 | Retrospective cohort study in patients who received a prescription of varenicline by their GP | Varenicline (without comparison) | GP-reported depression, anxiety, aggression, suicidal ideation, and non-fatal self-harm during three months since prescription of varenicline | NA | NA. The hazard during the observation period was constant for all events except for anxiety |
| Gunnell (2009)24 | Retrospective cohort study using GP database | Varenicline vs NRT Bupropion vs NRT | Fatal and non-fatal self-harm | Varenicline: 5.3, bupropion: 5.0, NRT: 7.5 | HR=1.12 (0.67 to 1.88) HR=1.17 (0.59 to 2.32) |
| Varenicline vs NRT | Depression | Not reported | HR=0.88 (0.77 to 1.00) | ||
| Bupropion vs NRT | HR=0.91 (0.77 to 1.07) | ||||
| Varenicline vs NRT | Suicidal thoughts | Not reported | HR=1.43 (0.53 to 3.85) | ||
| Bupropion vs NRT | HR=1.20 (0.28 to 5.12) |
*HR, hazard ratio; OR, odds ratio; RR, relative risk; all reported ratios are adjusted for potential confounders. NA, not applicable.