Public Health Impact of FDA's Request for Additional Safety Data on Cytisine for Tobacco Cessation.

IF 9.5 Q1 HEALTH CARE SCIENCES & SERVICES
Krishna P Reddy, A David Paltiel, Kenneth A Freedberg, Nancy A Rigotti
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引用次数: 0

Abstract

Importance: 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.

Objective: 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.

Exposure: Cytisine availability as a tobacco cessation treatment immediately or after 1 year.

Main outcomes and measures: The main outcomes were the number of adults able to stop smoking and sustain long-term abstinence and aggregate life-years gained.

Results: 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.

Conclusions and relevance: 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.

FDA 要求提供更多戒烟用 Cytisine 的安全性数据对公众健康的影响。
重要性:自 2006 年以来,美国尚未许可任何新的戒烟药物。Cytisine是一种基于植物的烟碱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,目前已在许多国家上市。不过,这种药物在美国还没有商业化。美国食品和药物管理局正在准备审查一项新药申请,以许可胞二磷胆碱在美国作为戒烟药物使用:目的:预测胞二磷胆碱作为戒烟辅助药物在美国上市的潜在公共卫生影响以及上市时间的延迟:该数学模型估算了美国 18 岁至 99 岁人群因戒烟而获得的预期寿命,反映了非住院人口中的平民情况。该模型还考虑了胞二辛的摄入量和有效性,以及戒烟者的潜在复吸率:主要结果和测量指标:主要结果是能够戒烟并保持长期戒烟的成人人数和获得的总寿命年数:基础案例包括约 2 940 万美国非住院成人吸烟者(年龄分布:18-24 岁,5.5%;25-44 岁,5.5%):5.5%;25-44 岁37.3%; 45-64 岁:41.8%;≥65 岁:15.5%).如果保守地假设这些人中有 3.8%会在上市后的第一年使用胞二磷胆碱,那么立即提供胞二磷胆碱可使 71 000 多人在一年内戒烟并保持长期戒烟。与无法获得胞二磷胆碱且戒烟人数较少的现状相比,这将增加 50 多万年的寿命。胞二磷胆碱的供应每延迟一年,人口预期寿命就可能减少 1 万年。模型结果对胞二磷胆碱摄入量和有效性的变化最为敏感:戒烟可大幅延长预期寿命。该数学模型表明,即使只有一小部分吸烟者成功使用,立即提供胞二磷胆碱也能产生巨大的公共卫生效益。鉴于对新的戒烟药物治疗方案的需求、胞二磷胆碱对公众健康潜在益处的巨大程度,以及延迟供应胞二磷胆碱所带来的发病率和死亡率,美国有必要及时审查胞二磷胆碱的审批。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
4.00
自引率
7.80%
发文量
0
期刊介绍: JAMA Health Forum is an international, peer-reviewed, online, open access journal that addresses health policy and strategies affecting medicine, health, and health care. The journal publishes original research, evidence-based reports, and opinion about national and global health policy. It covers innovative approaches to health care delivery and health care economics, access, quality, safety, equity, and reform. In addition to publishing articles, JAMA Health Forum also features commentary from health policy leaders on the JAMA Forum. It covers news briefs on major reports released by government agencies, foundations, health policy think tanks, and other policy-focused organizations. JAMA Health Forum is a member of the JAMA Network, which is a consortium of peer-reviewed, general medical and specialty publications. The journal presents curated health policy content from across the JAMA Network, including journals such as JAMA and JAMA Internal Medicine.
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