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Guidance
Smoking remains a significant public health concern, with tobacco use continuing to be a leading cause of preventable death and disease worldwide. Despite the availability of various smoking cessation interventions, many smokers still struggle to quit successfully. The current NICE guideline on tobacco dependence (NG209) recommends several pharmacological and behavioural interventions to support smoking cessation. However, new evidence suggests that cytisinicline, a plant-based alkaloid with a mechanism of action similar to varenicline, may offer an additional effective option for smokers attempting to quit.
This review question was selected to evaluate the effectiveness of cytisinicline as a potential new pharmacotherapy for smoking cessation in adults. Cytisinicline has been marketed as a smoking cessation aid since 1960. The inclusion of cytisinicline in this guideline update was prompted by emerging clinical trial data and its recent consideration for regulatory approval. As cytisinicline is not currently part of standard smoking cessation practice in the UK, this review aims to assess its efficacy and safety profile compared to existing treatments. The findings will inform whether cytisinicline should be recommended as an additional option for adults who smoke and want to quit, potentially expanding the range of effective smoking cessation interventions available to healthcare providers and patients.
The committee discussed the evidence for cytisinicline's effectiveness and safety compared to placebo, no medication, varenicline, and nicotine replacement therapy (NRT).
For smoking abstinence outcomes, they noted that cytisinicline demonstrated effectiveness compared to placebo, with a statistically significant effect at all measured time points. When compared with varenicline, cytisinicline showed similar effectiveness, with no significant differences in abstinence rates.
Limited evidence comparing cytisinicline with NRT suggested potential benefits of cytisinicline, though the committee noted this was based on fewer studies. The committee noted that cytisinicline was associated with more adverse events than placebo overall and specifically for insomnia and abnormal dreams. The committee discussed that differentiating between medication side effects and nicotine withdrawal symptoms can be challenging when evaluating adverse events in smoking cessation trials. When compared with varenicline, cytisinicline showed a similar overall adverse event profile, though with lower rates of nausea.
The committee agreed that the evidence showed cytisinicline to be an effective option for smoking cessation. They emphasised that having an additional treatment option would benefit people trying to stop smoking. As with all smoking cessation treatments, they noted that any treatment decision would be discussed with the individual, considering their preferences and circumstances. The committee discussed potential barriers to the implementation of cytisinicline in practice. These included the complexity of the dosing regimen which could affect adherence, the need to integrate the treatment into existing smoking cessation pathways, and how healthcare providers would manage prescribing and monitoring.
The committee noted that the shorter duration of cytisinicline treatment (25 days) compared to varenicline (typically 12 weeks) could be advantageous for some patients, while the more complex dosing schedule might be challenging for others. The committee noted that in some areas cytisinicline is already being prescribed. The committee reflected that patient choice is at the centre of treatment decision making and that the differences in and suitability of treatment options would be part of these discussions.