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September 6, 2015The Lancet Respiratory MedicineOpen Access

Cardiovascular and neuropsychiatric risks of varenicline: a retrospective cohort study

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Why the study?

Does varenicline or bupropion increase the risk of cardiovascular and neuropsychiatric events compared to nicotine replacement therapy in patients seeking smoking cessation?

Population

164,766 patients aged 18-100 years receiving a prescription for smoking cessation pharmacotherapy from 753…

Comparison

Varenicline (n=51,450) or bupropion (n=6,557) vs Nicotine replacement treatment (NRT) (n=106,759)

Design

Cohort

Follow-up

6 months

Authors

DKDaniel KotzWVWolfgang ViechtbauerCSColin R Simpson

Discussion

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Overview

Supports varenicline safety in real-world smokers; leaves open need for randomized confirmation of cardiovascular and neuropsychiatric risks.

Structured PICO

Does varenicline or bupropion increase the risk of cardiovascular and neuropsychiatric events compared to nicotine replacement therapy in patients seeking smoking cessation?

P
Population
164,766 patients aged 18-100 years receiving a prescription for smoking cessation pharmacotherapy from 753 NHS general practices across England. Excluded if they had used one of the drugs during the 12 months before the start date, received a prescription of a combination of these drugs during follow-up, or were temporary residents.
I
Intervention
Varenicline (n=51,450) or bupropion (n=6,557)
C
Comparator
Nicotine replacement treatment (NRT) (n=106,759)
O
Outcome
Incident cardiovascular (ischaemic heart disease, cerebral infarction, heart failure, peripheral vascular disease, and cardiac arrhythmia) and neuropsychiatric (depression and self-harm) events at 6 months follow-upsafety

Varenicline does not increase the risk of cardiovascular or neuropsychiatric events compared to nicotine replacement therapy, supporting its broader use for smoking cessation even in patients with comorbidities.

Limitations

  • Adverse events that do not come to attention of general practitioners cannot be excluded.

Cite This Study

Kotz et al. (2015) studied this question.

synapsesocial.com/papers/6a724606ac440176ef2a97edhttps://doi.org/10.1016/s2213-2600(15)00320-3
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1Risk of serious adverse cardiovascular events associated with varenicline: a systematic review and meta-analysis2011 · 288 citations
  2. 2Varenicline as a Cause of Suicidal Outcomes2015 · 17 citations
  3. 3Varenicline and suicidal behaviour: a cohort study based on data from the General Practice Research Database2009 · 203 citations
  4. 421st-Century Hazards of Smoking and Benefits of Cessation in the United States2013 · 1,809 citations
  5. 5Nicotine, alcohol and drug dependence and psychiatric comorbidity2001 · 297 citations