Results after 12 months showed that 8.4% of the participants randomised to receive cytisine had not relapsed (in other words, had successfully quit smoking), compared to 2.4% of the participants randomised to receive placebo. This was a difference of 6% (95% CI 2.7% to 9.2%), which equated to people taking cytisine being 3.4 times more likely to give up than those taking a placebo (95% CI 1.7 to 7.1).
The researchers report that this increase in the rate of giving up smoking is higher than that reported for the existing drug vareniciline (smokers taking varenicline are 2.3 times more likely to quit than those taking a placebo) and nicotine-replacement therapy (1.6 times more likely). However, the absolute difference in rate (in this case 6%) was lower than that shown for vareniciline, and similar to that shown for nicotine-replacement therapy. Some differences may be due to the length of the treatment period: only 4 weeks in this trial but 8 weeks for nicotine-replacement therapy and 12 weeks for vareniciline.
Gastrointestinal (stomach and intestine) side effects, predominantly stomach-ache, dry mouth, dyspepsia and nausea, were reported significantly more frequently in participants receiving cytisine (13.8%) than those receiving placebo (8.1%). There were no other side effects, which were significantly more frequent in the group receiving cytisine. The two groups had similar rates of drug discontinuation and dose reduction.
Although this study only lasted 12 months and was not large enough for an assessment of uncommon adverse events, the researchers report that the latest Periodic Safety Update Report provided to the European Authorities, based on more than 7 million exposed persons, did not identify any safety signals: in other words, the drug is considered safe.
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