Table 1

Overview of previous studies on cardiovascular and neuropsychiatric events in users of varenicline and bupropion

Author (year of publication)Study typeExposureOutcomeIncidence of events per 1000 patients per yearRelative event rates* (95% CIs)
Svanström (2012)29Retrospective cohort study using national patient registryVarenicline vs. bupropionCardiovascular event (acute coronary syndrome, ischaemic stroke, or cardiovascular death)Varenicline: 6.9, bupropion: 7.1HR=0.96 (0.67 to 1.39)
Acute coronary syndromeVarenicline: 4.7, bupropion: 3.9HR=1.20 (0.75 to 1.91)
Ischaemic strokeVarenicline: 1.9, bupropion: 2.5HR=0.77 (0.40 to 1.48)
Cardiovascular deathVarenicline: 0.4, bupropion: 0.7HR=0.51 (0.13 to 2.02)
Prochaska (2012)26Meta-analysis of 14 randomised controlled trialsVarenicline vs. placeboCardiovascular 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 reportedRR=1.40 (0.82 to 2.39)
Singh (2011)18Meta-analysis of 14 randomised controlled trialsVarenicline vs. placeboCardiovascular event (ischemia, arrhythmia, congestive heart failure, sudden death or cardiovascular-related death)Varenicline: 10.6, placebo: 8.2OR=1.72 (1.09 to 2.71)
Thomas (2013)28Retrospective cohort study using GP databaseVarenicline vs NRT Bupropion vs. NRTFatal or non-fatal self-harmVarenicline: 2.6, bupropion: 2.5, NRT: 3.6HR=0.88 (0.52 to 1.49)HR=0.83 (0.30 to 2.31)
Varenicline vs NRT Bupropion vs NRTTreated depressionVarenicline: 57.5, bupropion: 41.6, NRT: 77.5HR=0.75 (0.65 to 0.87)HR=0.63 (0.46 to 0.87)
Pasternak (2013)27Retrospective cohort study using national patient registryPsychiatric adverse event (emergency department visit or in-patient admission with a psychiatric diagnosis)Not reportedHR=0.85 (0.55 to 1.30)
Meyer (2013)31Retrospective cohort study using a military health system claims databaseVarenicline vs. NRTICD-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: 15.8HR=1.14 (0.56 to 2.34)
Buggy (2013)30Retrospective cohort study in patients who received a prescription of varenicline by their GPVarenicline (without comparison)GP-reported depression, anxiety, aggression, suicidal ideation, and non-fatal self-harm during three months since prescription of vareniclineNANA. The hazard during the observation period was constant for all events except for anxiety
Gunnell (2009)24Retrospective cohort study using GP databaseVarenicline vs NRT Bupropion vs NRTFatal and non-fatal self-harmVarenicline: 5.3, bupropion: 5.0, NRT: 7.5HR=1.12 (0.67 to 1.88)
HR=1.17 (0.59 to 2.32)
Varenicline vs NRTDepressionNot reportedHR=0.88 (0.77 to 1.00)
Bupropion vs NRTHR=0.91 (0.77 to 1.07)
Varenicline vs NRTSuicidal thoughtsNot reportedHR=1.43 (0.53 to 3.85)
Bupropion vs NRTHR=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.