Medical Practice Evaluation Center, Mongan Institute, Massachusetts General Hospital, Boston.
Tobacco Research and Treatment Center, Mongan Institute, Massachusetts General Hospital, Boston.
JAMA Health Forum. 2024 Aug 2;5(8):e242647. doi: 10.1001/jamahealthforum.2024.2647.
No new tobacco cessation medication has been licensed in the US since 2006. Cytisine, a plant-based partial agonist of nicotinic acetylcholine receptors, has demonstrated safety and efficacy in several randomized clinical trials and is currently available in many countries. However, the drug is not commercially available in the US. A New Drug Application to license cytisine as a smoking cessation medication in the US is being prepared for review by the US Food and Drug Administration, whose request for additional safety data will delay submission of the application by approximately 1 year.
To project the potential public health impact of cytisine, and delays in its availability, as a smoking cessation aid in the US.
DESIGN, SETTING, AND PARTICIPANTS: This mathematical model estimated life expectancy gains from smoking cessation for people aged 18 to 99 years in the US, reflecting the civilian, noninstitutionalized population. The model also accounted for cytisine uptake and effectiveness, as well as potential relapse among people who stop smoking.
Cytisine availability as a tobacco cessation treatment immediately or after 1 year.
The main outcomes were the number of adults able to stop smoking and sustain long-term abstinence and aggregate life-years gained.
The base case includes an estimated 29.4 million US civilian noninstitutionalized adults who smoke cigarettes (age distribution, 18-24 years: 5.5%; 25-44 years: 37.3%; 45-64 years: 41.8%; ≥65 years: 15.5%). With a conservative assumption that 3.8% of these individuals would use cytisine in the first year of availability, immediate cytisine availability could lead 71 000 more people to quit smoking over 1 year and maintain long-term abstinence. This would produce more than 500 000 additional life-years compared to the status quo in which cytisine is unavailable and fewer people stop smoking. Each additional year of delay in the availability of cytisine might reduce population-level life expectancy by 10 000 years. The model results were most sensitive to changes in cytisine uptake and effectiveness.
Smoking cessation generates large gains in life expectancy. This mathematical model demonstrated that immediate cytisine availability, even if used successfully by only a small fraction of people who smoke, could produce major public health benefits. Given the need for new tobacco cessation pharmacotherapy options, the magnitude of cytisine's potential public health benefits, and the morbidity and mortality associated with delay in its availability, a timely review of cytisine for approval in the US is warranted.
自 2006 年以来，美国还没有新的戒烟药物获得许可。烟碱类似物昔布特林是一种植物来源的烟碱型乙酰胆碱受体部分激动剂，已在多项随机临床试验中证明了其安全性和有效性，目前在许多国家都有销售。然而，该药尚未在美国上市。目前正在准备一份新药申请，以许可昔布特林作为美国的戒烟药物，美国食品和药物管理局（FDA）要求提供更多的安全性数据，这将使该申请的提交延迟约 1 年。
预测昔布特林作为戒烟辅助药物在美国的潜在公共卫生影响，以及其供应延迟的情况。
设计、地点和参与者：该数学模型估计了美国 18 至 99 岁人群因戒烟而获得的预期寿命增长，反映了平民、非住院人群。该模型还考虑了昔布特林的使用率和有效性，以及戒烟者中潜在的复吸情况。
昔布特林作为戒烟治疗药物的即时可用性或 1 年后的可用性。
主要结果是能够戒烟并长期保持戒断的成年人数量，以及获得的总寿命年数。
基础案例包括估计有 2940 万美国平民非住院成年人吸烟（年龄分布：18-24 岁：5.5%；25-44 岁：37.3%；45-64 岁：41.8%；≥65 岁：15.5%）。如果保守假设其中 3.8%的人会在第一年使用昔布特林，那么立即提供昔布特林可能会使另外 7.1 万人在 1 年内戒烟并长期保持戒断。与目前无法获得昔布特林且戒烟人数较少的情况下相比，这将产生超过 50 万的额外寿命年数。每延迟一年昔布特林的供应，可能会使人口平均预期寿命减少 10000 年。模型结果对昔布特林的使用率和有效性的变化最为敏感。
戒烟可显著提高预期寿命。该数学模型表明，即使只有一小部分吸烟者成功使用昔布特林，也能产生重大的公共卫生效益。鉴于需要新的烟草戒烟药物治疗选择，昔布特林的潜在公共卫生效益巨大，以及其供应延迟所带来的发病率和死亡率，美国及时审查昔布特林的批准是合理的。
