Cardiovascular and neuropsychatric risks of varenicline

What is the aim of the study and why is it important?

Varenicline is a drug that can help smokers quit. However, there are concerns about possible serious adverse events in users of this drug. The aim of the current study was to assess whether varenicline is related to such events, both in the general smoking population as in the subgroup of smokers with chronic obstructive pulmonary disease (COPD).

How is the research being done?

The study uses the QResearch database to identify a large group of smokers who received a prescription for either varenicline, bupropion (which is a different smoking cessation drug) or nicotine replacement therapy (for example nicotine gum or patch). All smokers are followed-up for six months to identify the following events: ischemic heart disease, stroke, heart failure, peripheral vascular disease, cardiac arrhythmia, depression, and self-harm. The data are analysed to compare the risks of these events in users of varenicline and bupropion, each compared with nicotine replacement therapy (which is presumed by regulators not to carry significant risks). All analyses are repeated in the subgroup of smokers with COPD.



Generic ethics approval reference


What were the main findings?

A total of 164,766 smokers were investigated; 106,759 had used nicotine replacement treatment, 6,557 bupropion, and 51,450 varenicline. Neither bupropion nor varenicline showed an increased risk of any cardiovascular event, depression or self-harm. Similar results were found in the subgroup of 14,350 smokers with COPD.

Implications and Impact

These findings suggest an opportunity for physicians to prescribe varenicline more broadly, even for patients with COPD, thereby helping more smokers to quit successfully than do at present.

Funding Source

QInnovation Award (provided by the software provider EMIS and the University of Nottingham) with additional support from the Ministry for Innovation, Science and Research of the German Federal State of North Rhine-Westphalia ("NRW-Rückkehrprogramm"), Cancer Research UK, the Medical Research Council and The Commonwealth Fund.​

Research Team

Daniel Kotz (Chief Investigator): Heinrich-Heine-University Düsseldorf Wolfgang Viechtbauer, Onno C.P. van Schayck: Maastricht University Colin Simpson, Aziz Sheikh: University of Edinburgh Robert West: University College London

Date on which research was approved



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