%0 Journal Article %T Does smoking cessation with varenicline worsen vascular endothelial function? %A Akira Umeda %A Heiichi Yano %A Hiroshi Takeda %A Kazuya Miyagawa %A Tamio Ieiri %A Tateki Yamane %A Toru Kato %A Yasumasa Okada %J - %D 2013 %R 10.1136/bmjopen-2013-003052 %X Objectives A meta-analysis suggested that the use of varenicline, which is a partial agonist of nicotinic acetylcholine receptors and is effective in smoking cessation, increases the risk of cardiovascular events within 52£¿weeks of starting treatment. Defining these events as occurring during drug treatment (usually for 12£¿weeks) or within 30£¿days of discontinuation, another meta-analysis showed that the risk was statistically insignificant. In the present study, we aimed to clarify the effect of varenicline-assisted smoking cessation on vascular endothelial function assessed by flow-mediated vasodilation (FMD). Design Before¨Cafter and time-series. Setting Tochigi Prefecture, Japan. Participants Data of 85 participants who visited nicotine-dependent outpatient services were reviewed. FMD was repeatedly measured in 33 of the 85 participants. Inclusion criteria: 20£¿years and older, Brinkman index ¡Ý200, Tobacco Dependence Screener ¡Ý5 and stated motivation to quit smoking. Interventions Each participant was treated with varenicline titrated up to 1.0£¿mg twice daily (for 12£¿weeks in total). Primary and secondary outcome measures Participants were evaluated by FMD prior to, and 3£¿months after, complete smoking cessation. Follow-up FMD measurements were carried out every 3£¿months if possible. Changes in FMD during varenicline use were also evaluated. Results FMD was significantly increased from 4.0¡À1.8% to 5.5¡À2.2% (p<0.01, n=22) 3£¿months after complete cessation. Although the timecourse of FMD in most of the cases showed an increase with fluctuations, there was an exceptional case where FMD decreased over the 9£¿months following complete cessation. Although statistically insignificant, FMD also increased during varenicline use (from 3.7¡À2.7% to 4.3¡À2.8%, n=11). Conclusions Our observations suggest that in ceasing smokers, varenicline and smoking cessation do not lead to a worsening of the vascular endothelial function. Trial registration FK-79 (International University of Health and Welfare) %U https://bmjopen.bmj.com/content/3/6/e003052