Abstract
PurposeVarenicline is an effective treatment for smoking cessation. While clinical trials did not confirm a causal role, case reports suggested a possible link of varenicline with neuropsychiatric adverse drug events (NPAEs). This study aims to investigate the risk of NPAEs associated with varenicline initiation among the general population in a real‐world setting.MethodsWe conducted a sequence symmetry analysis (SSA) based on the University of Groningen IADB.nl prescription database. We selected incident users of both varenicline and marker drugs for NPAEs, including depression, anxiety and sleep disorder within different time‐intervals. Adjusted sequence ratios (aSR) were calculated for each time‐interval.ResultsWithin 365‐days' time‐interval 1066 patients were incident users of both varenicline and NPAE marker drugs. In total, 505 patients were prescribed varenicline before NPAE marker drugs and 561 vice versa (crude sequence ratio [cSR] 0.90, 95% CI: 0.80–1.02). After adjustments for trends in prescriptions, overall a null association was found (aSR 1.00, 95% CI: 0.89–1.13). Regarding specific NPAEs, no increased risks were found for depression nor anxiety within any time‐interval. A small transient increased risk was found for sleep disorders, particularly in earlier time‐intervals 3 and 6 months (aSRs 1.52, 95% CI: 1.10–2.11 and 1.45, 95% CI: 1.15–1.83, respectively). Subgroup and sensitivity analyses showed similar findings.ConclusionsVarenicline initiation was unlikely to be associated with an increased risk of taking anti‐depressants nor anti‐anxiety drugs. Yet a small, but statistically significant, transient association with drugs for sleep disorders was noticed, possibly associated with withdrawal symptoms caused by smoking cessation.
Highlights
The prevalence of tobacco use has been declining in recent years,[1] the tobacco epidemic is still one of the largest public health threats, related to more than 8 million deaths worldwide each year.[2]
17 patients were excluded because they were prescribed varenicline and marker drugs at the same day and 1457 patients were excluded as they were captured within the run-in period of the first 3 months and may not be new users of marker drugs as shown in the waiting-time distribution (Figure 2) that there was a steep decrease at the beginning of the study period after which a more or less stable situation was reached after 3 months, that is, when prevalent users were basically not in the newly captured population
No statistical significant association was observed between varenicline and depression nor anxiety
Summary
The prevalence of tobacco use has been declining in recent years,[1] the tobacco epidemic is still one of the largest public health threats, related to more than 8 million deaths worldwide each year.[2] Smoking-related health problems are associated with a high burden for both family and society.[3] To help halt this burden, varenicline as a first-line pharmacological smoking cessation treatment (PSCT) was approved by the US Food and Drug Administration (FDA) in 2006. Such information undoubtedly has led to the underutilization of varenicline for smoking cessation.[11,12,13]
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