British American Tobacco (Investments) Limited, Research and Development, Southampton, UK.
Nicotine Tob Res. 2021 Feb 16;23(3):584-591. doi: 10.1093/ntr/ntaa135.
Tobacco heating products (THPs) generate lower machine yields of toxicants compared to those found in conventional cigarette smoke. During use, these products are likely to expose users to lower levels of particulate matter and harmful and potentially harmful compounds compared with smoking cigarettes.
This randomized, controlled study is investigating whether biomarkers of exposure (BoE) to smoke toxicants are reduced when smokers switch from smoking cigarettes to using the glo THP in a naturalistic, ambulatory setting. Control groups include smokers who are abstaining from cigarette smoking and never-smokers. At a baseline study visit, 24-hour urine samples and spot blood samples were taken for BoE analysis, and exhaled carbon monoxide was also measured. N-(2-cyanoethyl) valine (CEVal) was used as a marker of compliance in subjects asked to refrain from combustible cigarette smoking. Subjects are being followed up at periodic intervals for 360 days; this article presents data following a planned interim analysis at day 90.
In continuing smokers, BoE remained stable between baseline (day 1) and day 90. In both per-protocol and CEVal-compliant analysis populations, reductions in BoE were observed in subjects switching to using glo or undergoing smoking cessation. These reductions were statistically significant for a number of BoE when switching to glo was compared with continued smoking. Furthermore, in both populations, reductions observed in subjects switching to using glo were comparable to those seen with smoking cessation and were also to levels similar to those seen in never-smokers.
glo is a reduced-exposure tobacco product.
This clinical study builds on a previous 5-day confinement study and demonstrates that when smokers switched from smoking combustible cigarettes to using the glo THP in a naturalistic, ambulatory setting, their exposure to tobacco smoke toxicants was significantly decreased. For most BoE examined, this was to the same extent as that seen when a control group of smokers ceased cigarette smoking, or even to levels seen in never-smoker controls. This indicates that glo is a reduced-exposure product with the potential to be a reduced-risk tobacco product, when used by smokers whose cigarette consumption is displaced completely.
ISRCTN81075760.
与传统卷烟烟雾相比，加热烟草制品（THP）产生的有毒物质机器产量较低。在使用过程中，与吸烟相比，这些产品可能会使使用者接触到较低水平的颗粒物以及有害和潜在有害化合物。
这项随机对照研究旨在调查吸烟者在自然环境中从吸烟转为使用 glo THP 时，是否会降低对烟雾有毒物质的暴露生物标志物（BoE）。对照组包括正在戒烟的吸烟者和从不吸烟者。在基线研究访问中，采集 24 小时尿液样本和点血样本进行 BoE 分析，并测量呼出的一氧化碳。N-（2-氰乙基）缬氨酸（CEVal）被用作要求避免可燃香烟吸烟的受试者的依从性标志物。受试者正在定期随访 360 天；本文介绍了在第 90 天进行计划中期分析后的结果。
在继续吸烟者中，BoE 在基线（第 1 天）和第 90 天之间保持稳定。在符合方案和 CEVal 符合分析人群中，与继续吸烟相比，转为使用 glo 的受试者的 BoE 均有所降低。与继续吸烟相比，当转换为 glo 时，这些 BoE 的降低在统计学上是显著的。此外，在这两个人群中，与继续吸烟相比，转为使用 glo 的受试者观察到的降低与戒烟时观察到的降低相当，并且也与从不吸烟者相似。
glo 是一种低暴露的烟草产品。
这项临床研究建立在前一项为期 5 天的封闭研究的基础上，表明当吸烟者从吸食可燃香烟转为在自然环境中使用 glo THP 时，他们接触烟草烟雾有毒物质的程度显著降低。对于大多数检查的 BoE，这与对照组吸烟者戒烟时的程度相同，甚至与从不吸烟者对照组的水平相同。这表明 glo 是一种低暴露产品，当完全取代吸烟者的香烟消费时，它有可能成为一种降低风险的烟草产品。
ISRCTN81075760。
