Varenicline and risk of psychiatric conditions, suicidal behaviour, criminal offending, and transport accidents and offences: population based cohort study
Key result
Varenicline linked to ~18% higher risk of psychiatric conditions, limited to patients with pre-existing disorders.
- HR 1.18
- 95% CI 1.05 to 1.31
- n=7,917,436
Why the study?
Does varenicline increase the risk of psychiatric conditions, suicidal behaviour, criminal offending, and transport accidents in the general population?
Population
7,917,436 people aged 15 and over in Sweden, of whom 69,757 were treated with varenicline between 2006 and…
Comparison
Varenicline vs Periods of non-treatment within the same person…
Design
Cohort
Follow-up
2006 to 2009
Authors
Discussion
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Implication
Supports varenicline safety for major adverse events in observational data; leaves open whether the modest psychiatric signal warrants monitoring or RCTs in those with prior disorders.
Study Design
Type
Cohort (n=7,917,436)
Structured PICO
Does varenicline increase the risk of psychiatric conditions, suicidal behaviour, criminal offending, and transport accidents in the general population?
P
Population
7,917,436 people aged 15 and over in Sweden, including 69,757 treated with varenicline, followed from 2006 to 2009 to assess adverse psychiatric and behavioral outcomes.
E
Exposure
Varenicline (at least one collected prescription, defined as 12-week treatment periods)
C
Comparator
Periods of non-treatment within the same person (within-person design) and non-treated individuals (between-person design)
O
Outcome
Incidence of new psychiatric conditions (psychoses, mood conditions, anxiety conditions), suicidal behaviour, suspected and convicted criminal offending, transport accidents, and suspected and convicted traffic offencessafety
Main Result
Hazard Ratio: 1.18 (95% CI 1.05–1.31)
Varenicline is not associated with an increased risk of suicidal behavior, criminal offending, or transport accidents, though a small increased risk of mood and anxiety conditions was observed in patients with pre-existing psychiatric disorders.
Limitations
- Did not account for time-varying confounding factors such as nicotine withdrawal or non-adherence to other drugs
- Use of official registers underestimates true rates of most outcomes by only capturing serious events requiring hospital visits or police detection
- Unable to account for lack of or variations in adherence to varenicline
- Conducted in Sweden, which has a relatively low prevalence of daily smokers, potentially affecting generalizability
- Lack of information on time varying covariates
- Use of official registers, which underestimate true rates of most outcomes
- Unable to account for lack of or variations in adherence
- Conducted in Sweden, a country with a relatively low prevalence of daily smokers
Cite This Study
Molero et al. (2015) conducted a cohort in Tobacco dependence (n=7,917,436). Varenicline vs. Periods of non-treatment within the same person was evaluated on Incidence of new psychiatric conditions (HR 1.18, 95% CI 1.05 to 1.31). Varenicline was not associated with suicidal behavior, criminal offending, or transport accidents, but was associated with a small increased hazard of new psychiatric conditions (HR 1.18) that was limited to individuals with pre-existing psychiatric disorders.