Ocena skuteczności cytyzyny w leczeniu uzależnienia od tytoniu – badanie kliniczne, próba z placebo Omówienie artykułu: Placebo-Controlled Trial of Cytisine for Smoking Cessation West R., Zatoński W., Cedzyńska M., Lewandowska D., Pazik J., Aveyard P., Stapleton J. N. Engl. J. Med. 2011; 365: 13

Abstract

Results of international trial on cytisine, a partial agonist that binds with high affinity to the α4β2 nicotinic acetylcholine receptor, safety and effectiveness in aiding smoking cessation as compared with placebo, were presented in the paper. There was conducted a single-center, randomized, double-blind, placebo-controlled trial. Participants were randomly assigned to receive cytisine or matching placebo for 25 days. The primary outcome measure was sustained, biochemically verified smoking abstinence for 12 months after the end of treatment. Of 1542 adult smokers screened, 740 were enrolled and 370 were randomly assigned to each study group. The rate of sustained 12-month abstinence was 8.4% (31 participants) in the cytisine group as compared with 2.4% (9 participants) in the placebo group (difference, 6.0 percentage points; 95% confidence interval [CI]: 2.7 to 9.2; p = 0.001). The 7-day point prevalence for abstinence at the 12-month follow-up was 13.2% in the cytisine group versus 7.3% in the placebo group (p = 0.01). Gastrointestinal adverse events were reported more frequently in the cytisine group (difference, 5.7 percentage points; 95% CI: 1.2 to 10.2). Gastrointestinal adverse events were reported more frequently in the cytisine group (difference, 5.7 percentage points; 95% CI: 1.2 to 10.2). In conclusion, cytisine was more effective than placebo for smoking cessation and the lower cost of cytisine as compared with that of other pharmacotherapies for smoking cessation may make it an attractive treatment option.