The researchers tested the heated plant system from Isenzia ™ and found it delivering nicotine with far fewer harmful chemicals than cigarettes, which aroused a debate on the question if it could offer smokers a safer alternative.
Study: evaluation of the potential for reducing tobacco harm of heated plant products: preclinical and clinical studies. Image credit: Olga Vasilyeva / Shutterstok.com
A recent study in Toxicology borders Evaluated the results of the preclinical and clinical study to understand the potential for heated plants to reduce tobacco damage. This study indicates the potential of the Isenzia ™ heated plant system (HHS) in the production of satisfactory nicotine levels with reduced harmful effects compared to cigarettes.
Health smoking effect
Smoking is associated with multiple diseases, including lung cancer, emphysema, reproductive / developmental toxicity and cardiovascular disease. Smoking leads to more than 7 million deaths per year in the world. Most diseases caused by smoking come from the inhalation of burned tobacco smoke which contains around 7,000 chemicals. Among these, nicotine is an addictive compound, and although it is not without risk, it is not considered directly responsible for the main damages of smoking health.
Clinicians have urged cigarette smokers to leave or reduce smoking to reduce their exposure to harmful and potentially harmful constituents (HPHC) present in cigarettes, which would decrease their risk of multiple diseases.
Although many smokers try to leave smoking every year, only a few succeed. For people who do not want or who are not interested in quitting smoking, approaches to reducing tobacco (THR) harms aim to reduce damage associated with smoking. In 2001, the American Institute of Medicine (OIM) introduced the THR concept in the “Clearing The Smoke” report to reduce exposure to harmful toxic to toxic to reducing global morbidity and mortality.
THR can be obtained by reducing the consumption of cigarettes, by lowering the risk associated with tobacco consumption or by reducing the prevalence of use. Consequently, the production of new nicotine and tobacco products which give nicotine without emitting HPHC and other toxic to diseases related to smoking is necessary.
Heated tobacco products compared to products based on heated plants
Recent studies have highlighted the use of heated tobacco products (HTPS) as an alternative to products containing nicotine for adult smokers. HTPS electrically heat a tobacco substrate in a controlled manner to generate an aerosol containing nicotine. Since the heating temperature is considerably lower than that necessary to burn cigarettes, HPHC levels and other toxic to HTP aerosols are significantly lower than those of cigarette smoke.
Unlike HTP, plant -based products (HHP) electronically heat a non -tobacco substrate and containing nicotine, generating an aerosol containing nicotine. Few studies have evaluated the impact of HHP on health.
About the study
This study explored preclinical and clinical studies to assess a new heated plant -based system (HHS) called Isenzia ™. This system includes Pulze ™ 2.0 and Isenzia ™ sticks. Preclinical studies have considered two sticks from Isenzia ™: forestry bay and summer watermelon.
The clinical study involved 25 candidates. The study cohort included 40% of men and all the subjects were white. All participants smoked cigarettes not on frame as a usual brand.
Study results
The results of preclinical studies have indicated the generation of aerosols from the Isenzia ™ study group, and six of the Nine Analysts of the World Health Organization (WHO) on the analysts of the regulation of tobacco products (Tobreg 9) were lower than the limits of quantification (LOQ). The levels of the three quantifiable analysts (acetaldehyde, acroleine and carbon monoxide) were approximately 96 to 99% lower than those measured in the 1R6F reference cigarette smoke.
Compared to the 1R6F reference cigarette smoke, Forest berries et Summer watermelon was significantly 65% lower and 67%, respectively. In addition, a mass of mass collected by aerosol (ACM) lower has been measured for Isenzia ™ HHS aerosols, compared to the total particle material (TPM) in the entire 1R6F reference cigarette cigarette of around 18% for the two flavor variants.
The cytotoxicity test has revealed that more puffs are necessary to induce toxicity, compared to the 1R6F reference cigarette smoke. Likewise, greater mutagenicity and genotoxicity have been observed in the reference cigarette smoke compared to the variant aerosols of Isenzia ™ HHS. However, the micronucleus test was positive for Isenzia aerosols and cigarette smoke, although Isenzia aerosols have shown much lower genotoxic power.
For the clinical study, any test product used in controlled food sessions has revealed a rapid increase in plasma nicotine levels. On average, participants took 9.3 puffs from each of the Isenzia ™ stick variants and 10.3 puffs from their usual brand cigarettes. Compared to the usual brand cigarettes, each of the Isenzia ™ flavors variants had a value significantly lower than the area under the plasma nicotine concentration (AUC) and the maximum average plasma nicotine concentration.
No statistically significant difference has been observed between Isenzia ™ HHS flavor variants and the usual brand cigarettes concerning median time to reach the maximum concentration of plasma nicotine. Cigarettes have produced the most significant reduction in the desire to smoke (highest Emax); The variants of Isenzia have less reduced the desire (from ~ 36-38%) and reached their maximum effect later (higher temax).
In the evaluation of products, the participants reported lower satisfaction, a psychological reward and relief for the variants of Isenzia compared to cigarettes. The intention rates of reception were 52% (forestry bays) and 44% (summer watermelon), against 76% for usual brand cigarettes.
This study has not pointed out any serious and uncommon undesirable effect (AE). Lightness and light nausea have turned out to be the most reported IS.
Conclusions
The results of the preclinical and clinical study indicate that the aerosol of HH Isenzia ™ contains significantly lower levels of HPHC and toxic than cigarette smoke. The lower levels considerably reduce the biological impact, supporting reduced exposure and lower biological activity, but the reduction of long -term harm has not yet been established.
Given that nicotine delivery and product assessment measures were lower than those of cigarettes, the authors suggest that Isenzia could have a lower liability while supporting adult smokers who would otherwise continue to smoke. Together, these results support a reduced exposure and a potential of responsibility at lower cost for Isenzia compared to cigarettes; The long -term impact of health and the effectiveness of switching remains to be established.
The authors also note the limits: a small and narrow demographic sample, a single diet of laboratory puffs, a limited analyte panel and no long -term or real result. They underline the need for broader chemistry, studies of long -term biomarkers and switching data. Imperial Brands PLC funded the study, and most authors are employees of the company that manufactures Isenzia.
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