RISK REDUCTION ASSESSMENT: EPIDEMIOLOGY AND NOVEL APPROACHES

Abstract

Introduction. Today, there are new approaches to assessing the potential impact of alternative nicotine delivery systems, such as systemic toxicology and biomarker assessment. The modern development of science and technology, including laboratory research, allows for a detailed assessment of the biological effects of a substance or complex of substances on the human body as a whole. The aim of the study: to compare and assess based on literature data possibility to broaden the standard approach for risk reduction assessment for lifestyle (potentially correctable) risk factors, especially tobacco smoking (TS). While epidemiology remains a golden standard for risk reduction assessment, novel approaches are based on preventive or system toxicology analysis and biomarkers of harm evaluation, thus it is crucial to understand both benefits and limitations of novel and standard approaches to complete risk reduction assessment for potentially correctable risk factors. Materials and methods. The thematic scientific papers, published predominantly during the last decade, constituted the study material. The research methodology involved bibliosemantic method and structural and logical analysis. Results and discussion. Level of modern scientific development already can help us to assess the harm made by new/emerging products based on epidemiological, toxicological data and evaluation of biomarkers of potential harm for specific risk or disease. For TS biomarkers of harm are mostly well established and include 15 Harmful and Potentially Harmful Constituents (HPHCs) of tobacco smoke and their metabolites in the body. Reduction in Total-3-OH-B[a]P, S-PMA, COHb and other can show reduction in harm and risk caused by new/emerging product. So far most comprehensive analysis of reduction in HPHCs and biomarkers manifestation was concluded for tobacco heating system as TS alternative. Switching from cigarettes to THS for 5 days resulted in 56 % to 96 % reductions in 15 exposure biomarkers in the THS group compared to the TS group. These values approached the decrease in effect observed in the group of complete refusal of TS. Similar observations were made for the 90-day studies, where the reduction observed on day 5 was maintained until the end of the three-month studies and confirmed by other 3 clinical studies. Conclusions. In general, the results of the risk reduction assessment based on novel approaches confirms that THS is an acceptable alternative to cigarettes for adult smokers, and based on the positive biological effects, the transition to THS represents a lower risk for the smoker’s body with regard to the effects of HPHCs.