International Journal of Medical Sciences

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13 December 2017

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Int J Med Sci 2017; 14(10):920-926. doi:10.7150/ijms.19877

Research Paper

Identification and Characteristics of Time-Related Shifts in Suicide-Related Event Frequency During Smoking Cessation Treatment with Varenicline

Hayato Akimoto1, Haruna Wakiyama1, Shinji Oshima1, Akio Negishi1, Kousuke Ohara1,2, Sachihiko Numajiri1, Mitsuyoshi Okita3, Shigeru Ohshima1, Naoko Inoue1, Daisuke Kobayashi1✉

1. Faculty of Pharmaceutical Sciences, Josai University; 1-1 Keyakidai, Sakado, Saitama, 350-0295, Japan
2. Faculty of Pharmaceutical Sciences, Josai International University; 1 Gumyo, Togane, Chiba, 283-8555, Japan
3. Josai University Pharmacy, 909-4 Simogawara, Moroyama, Iruma, Saitama, 350-0435, Japan.

Abstract

Objectives: To survey time-related shifts in number of suicide-related events (SRE) during smoking cessation treatment with varenicline (VAR) in cases from the U.S. Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS), as well as the characteristics of these shifts.

Methods: We isolated cases from the FAERS database involving VAR usage where SRE was reported as an adverse event (SRE+/VAR+ case) and established a histogram of SRE+/VAR+ case numbers per week. Furthermore, we focused on “cases reporting specific adverse events prior to drug usage start” using X-bar and R chart concepts. We also attempted to exclude the influence of smoking history from the created histogram. Moreover, we constructed a histogram on central nervous system adverse events, which were frequently seen during VAR usage.

Results: By removing the effects of smoking history, SRE onset signals were detected over a long period from the start of VAR use. However, expression signals for nausea and abnormal dreams were detected only in the early VAR administration period.

Discussion: These results suggest that VAR use-induced SRE is expressed over a long timeframe from the start of treatment. Additionally, the period of SRE expression signal detection was longer than that of the other central nervous system adverse events (nausea and abnormal dreams). Therefore, SRE onset must be carefully monitored during smoking cessation treatment with VAR over the entire treatment period.

Keywords: suicide-related event, varenicline, case study, FAERS, smoking cessation

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How to cite this article:
Akimoto H, Wakiyama H, Oshima S, Negishi A, Ohara K, Numajiri S, Okita M, Ohshima S, Inoue N, Kobayashi D. Identification and Characteristics of Time-Related Shifts in Suicide-Related Event Frequency During Smoking Cessation Treatment with Varenicline. Int J Med Sci 2017; 14(10):920-926. doi:10.7150/ijms.19877. Available from http://www.medsci.org/v14p0920.htm