Use of IQOSTM (a heated tobacco product) in Italy: A cross-sectional survey

doi:10.21203/rs.3.rs-2107750/v1

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Use of IQOS^TM (a heated tobacco product) in Italy: A cross-sectional survey

https://doi.org/10.21203/rs.3.rs-2107750/v1

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Background: Limited data are available on the use of heated tobacco products (HTPs) and specifically the use of IQOS™ in Italy. Here, we present the results of a cross-sectional survey on a randomly selected sample of registered of IQOS™ legal age users with the aim of assessing their use behaviors associated with IQOS™ and previous tobacco use history to better understand patterns of IQOS™ use at individual and population levels in Italy.

Methods: A quantitative survey on 3002 interviews was conducted from May 20 to May 26, 2020, on a sample of IQOS™ users of both sexes, aged 18-80 years and who had used at least 100 tobacco units (HEETS^TM) in their lifetime.

Results: The mean age at the time of starting using IQOS^TM was 36.3 years. Only 0.8% had started regularly (at least 1 HEETS^TM per day) using IQOS™ at 16-<18 years, whereas the majority started at 25-44 years (52.5%). For 64% of respondents, IQOS™ was their exclusive tobacco product, whereas 36% used IQOS™ in combination with another tobacco and/or nicotine product (TNP) (mainly IQOS™ and cigarettes: 25%). Ninety percent of IQOS™ users were cigarette smokers (89.7%) or e-cigarette users (0.3%) at the time when they started using IQOS™. Only 0.6% had never smoked, and 8.3% were former cigarette smokers or e-cigarette users when they started to use IQOS™.

Conclusions: The vast majority of respondents were already smokers when they switched to IQOS™, suggesting that the product does not pose a strong risk of attracting nicotine-naïve users. Further, most IQOS™ users in this survey reported they no longer smoke cigarettes. Our findings indicate that the use of alternative TNPs has the potential to reduce the number of cigarette smokers in Italy.

Italy

heat-not-burn

heated tobacco product (HTP)

IQOS

tobacco harm reduction

cross-sectional survey

Tobacco Heating System

Non-communicable diseases (NCDs) are responsible for 92% of deaths in Italy [1]. Most of these diseases are attributable to an unhealthy lifestyle that increases the long-term risk of morbidity/mortality [2]. The principal risk factors include smoking, an unhealthy diet, excessive alcohol consumption, and insufficient exercise [2]. Among these, smoking is strongly associated with four of the six main NCDs: tracheal, bronchial, and lung carcinomas; chronic obstructive pulmonary disease; stroke; and coronary heart disease [3–7].

Quitting smoking is the most effective strategy to reduce the risk of disease in smokers. Over the last few decades, the primary strategy to reduce cigarette smoking prevalence focused on preventing smoking initiation and promoting smoking cessation. Unfortunately, despite public health efforts, and the significant progress made to date in decreasing the smoking prevalence, the success rate of attempting to quit remains very low (in Italy, the success rate 6 months after a quitting attempt is only 9.6%) [8], and even in smoking cessation with pharmacological treatment, the abstinence rate tends to significantly diminish within 1 year after treatment [9].

Additional gains could be made by applying harm reduction approaches in adult smokers [10,11]. The approach focuses on switching adult cigarette smokers away from cigarettes to alternatives that have the potential to reduce individual risk and population harm in comparison with continued smoking of cigarettes [12]. With this in mind, it is important to note that most of the harmful effects of cigarette smoking on health are not produced by nicotine but by the toxic substances produced during tobacco combustion that cause or could cause harm to smokers or nonsmokers [13,14], also known as harmful or potentially harmful constituents (HPHCs) found in tobacco products or tobacco smoke [15].

Several tobacco and/or nicotine-containing products (TNPs) have emerged in recent years that have the potential to support harm reduction strategies, most prominently electronic cigarettes (e-cigarettes) and heated tobacco products (HTPs). Both products eliminate the combustion of tobacco, which is the primary source of high levels of HPHCs in cigarette smoke. While e-cigarettes heat a liquid to release nicotine-containing aerosol that users inhale, HTPs heat tobacco without burning it, to generate nicotine-containing aerosol. IQOS™, which is an HTP, was launched in Japan and Italy in 2014 [16]. The aerosol generated by IQOS™ contains reduced toxicant emissions [17, 18], and its use in clinical studies showed reduced exposure to HPHCs compared to cigarettes [19, 20].

For harm reduction strategies to be successful, cigarette alternatives must have the potential to be less harmful than continued smoking, be able to transition adults who would otherwise continue to smoke cigarettes completely away from smoking, and not lead to widespread initiation among nonsmokers who would otherwise not initiate tobacco or nicotine use. Therefore, it is important to assess the level of complete switching in IQOS™ users and understand whether IQOS™ is used alone or in combination with cigarettes and/or other combustible or non-combustible TNPs.

In Italy, there are still limited data available on the use of smoke-free systems, and particularly on the use of IQOS™ [21]. Here, we present the results of a cross-sectional quantitative survey of legal age users who purchased IQOS™, with the main goals of assessing the adoption and current use of IQOS™ in Italy and analyzing behaviors, consumption patterns of other TNPs.

Subjects were randomly selected from among registered IQOS™ users (PMI database of adult purchasers who accepted to be registered) who agreed to be contacted for market research purposes, in compliance with the Data Protection Authority (GPDP)’s regulations [22] and ESOMAR (European Society for Opinion and Market Research) code (baseline International standards for data-driven projects) [23].

The PMI database of adult purchasers is representative of the entire population of IQOS™ users in Italy, as any purchase must be registered in the database before selling the system; just 2.7% of registered sales were not linked to any user in 2020.

From the Philip Morris initial database of 806,000 users, individuals with missing information like age, geographical area, sex, and contact email address or phone number were excluded as potential participants from the survey, resulting in a baseline potential pool of 460,000 individuals. Interview subjects were randomly chosen from this pool for a total of 90,000 individuals. Initial screening questions were used to verify IQOS™ use and eligibility. No respondent was screened out by the initial screening questions. There was no weighting of the data because the sample was constructed as representative of the initial database by sex and age. Employees of Philip Morris International or any of its affiliates were excluded.

From May 20 to May 26, 2020, computer-assisted telephone interviewing (CATI) of 2000 subjects and computer-assisted web interviewing (CAWI) of 1002 subjects (methods described elsewhere) [24] were conducted. The total sample of 3002 legal age IQOS™ users included residents of Italy, of both sexes, aged between 18 and 80 years, currently using IQOS™, and with a usage of at least 100 tobacco units (HEETS^™) in their lifetime, independent of their smoking status. The survey was carried out by BVA DOXA S.p.A., a market and public opinion research company in Italy.

Through the combined use of CATI and CAWI methodologies, it was possible to reach all of the target groups to gather information about their consumption behaviors and initiation and usage patterns. With CATI it is possible to interview individuals (target group) who do not own a computer or do not have computer skills, whereas with CAWI it is possible to reach individuals (target group) who do not use a landline at home and all those who own and use a computer or a mobile phone with some proficiency.

The sample of 3002 participants contained slightly more males than females (56% vs. 44%). Among participants, 15% were in the age range 18–24 years, 54% in the range 25–44 years, 29% in the range 45–64 years, and 2% in the range 65–80 years (mean age of the total sample = 38 years; SD = 12.4) (Table 1). Most users had a medium (high school with degree) to high (university with or without degree) level of education (87%).

Table 1

*IQOS™* use among the 3002 participants according to sex, age, and education level.
Sex, age & education level (IQOS™ users)	Daily IQOS™ users (n = 2740) (%)	Occasional IQOS™ users (n = 262) (%)	Exclusive IQOS™ users (n = 1907) (%)	Non-exclusive IQOS™ users (n = 1095) (%)
Male (any age)	57	51	53	62
Female (any age)	43	49	47	38
18–24 yrs	16	14	14	17
Male	56	61	NA	NA
Female	44	39	NA	NA
25–44 yrs	53	55	55	51
Male	42	57	NA	NA
Female	58	43	NA	NA
45–64 years	29	31	28	30
Male	40	29	NA	NA
Female	60	71	NA	NA
65–80 years	2	0	3	2
Male	39	0	NA	NA
Female	61	0	NA	NA
University degree	28	31	30	27
University no degree	6	3	6	5
High school	52	56	51	54
Second. or elem. school/no school	14	10	13	14
NA = not available

The vast majority of participants used IQOS™ on a daily basis (91%), while 9% were occasional users. Both daily users (DU) and occasional users (OU) of IQOS™ were equally distributed among sex, and the majority of users in both groups were in the 25–44 age range (53% and 55%, respectively) (Table 1). On average, DU consumed 13 HEETS™ per day. OU consumed 1–3/day, 4–6/day, and > 6/day (maximum range value, i.e., how many above 6/day, not asked) HEETS™ in 71%, 20%, and 9% of cases, respectively. For OU, participants reported IQOS™ use on 11.5 days on average in the previous 30 days.

The mean age at the beginning of regular use of IQOS™ (at least 1 HEETS™ per day) was 36.3 years (36.5 and 32.8 years in DU and OU, respectively) (age range 18–80 years in this group). Only 0.8% of participants started using IQOS™ between 16 and < 18 years and 17.1% between 18 and 24 years (full data are shown in Table 2).

Table 2

Age at the start of regular *IQOS™* use (at least 1 *HEETS*^TM/day) of *IQOS™*.
Range (years) Base = 2859 regular IQOS™ users	%
16-<18	0.8
18–24	18.0
25–44	52.5
45–64	22.9
65–80	1.5
Question unanswered	4.3

Among participants, 64% used IQOS™ as their exclusive tobacco product, and 36% used IQOS in combination with another TNP. Within the 3002 participants, exclusive and non-exclusive IQOS™ users were proportionate to the sample (53% and 62% male, respectively) and in the 25–44 years age range (55% and 51%, respectively) (Table 1). Non-exclusive users of IQOS™ combined its use with other tobacco products as follows: 25% IQOS™ + cigarettes (CC); 6% IQOS™ + CC + other TNP; 2% IQOS™ + other TNP; 2% IQOS™ + e-cigs; 1% IQOS™ + e-cigs + CC. The cigarette smoking behaviors (number of cigarettes smoked per day) of 3002 survey participants are summarized in Fig. 1.

Among IQOS™ users, 90% were cigarette smokers (89.7%) or e-cigarette users (0.3%) when they started to use IQOS™ (1.1% of participants did not respond to the question). The sex of participants who switched from cigarette smoking was proportionate to the sample, (53% male, 47% female) with a mean age of 38 years (19–24 years: 16%; 25–44 years: 53%; 45–64 years: 29%; 65–80 years: 2%).

On average, these users started smoking regularly at 18 years of age, and the cigarette smokers were smoking a mean of 16 cigarettes per day when they started to use IQOS™. Only 0.6% of participants stated to have never smoked cigarettes in their lifetime at the time they began IQOS™ use, whereas 8.3% of participants were former cigarette smokers or e-cigarette users (7.9% and 0.4%, respectively). The abstinence period lengths of former smokers before commencing IQOS™ use are shown in Table 3.

Table 3

Length of previous abstinence in former smokers at the time of *IQOS™* initiation.
Length	%
12 months^a	13.0
12–24 months	12.0
25–36 months	8.0
3–9 years	10.0
> 10 years	10.0
No answer available	47.0
^aOf which 6% was < 3 months.

The proportions of participants with different histories of tobacco use were largely similar across the DU and OU categories: most (95% and 88%, respectively) were active smokers when they started using IQOS™, while the majority of non-active smokers were former smokers (4.6% of participants in DU and 11.2% in OU). Only a small minority had never smoked (0.3% in DU and 0.8% in OU). The remaining participants (0.2% of DU and 0.4% of OU) did not respond to this question.

Among IQOS™ users, 64% had never used e-cigs. Of the 36% of participants who had used e-cigs, 65% used them regularly (at least once a day). The mean age when they started using e-cigarette was 34.5 years. Among previous e-cig users who had switched to IQOS™ (n = 312), 59% quit e-cigs at least 1 year before starting to use IQOS™, 29% quit within the same year and 12% quit using e-cigs after having started to use IQOS™.

The use of other TNPs (besides cigarettes) was extremely limited among IQOS™ users. Smokeless tobacco was used by 7% of participants, other TNPs were used by 28% of participants, and 21% had used them in the past but no longer used them at the time of the survey. Around 5% used nicotine replacement therapy products.

Most IQOS™ users (65%) did not intend to quit its use within the next 6 months. Among all sub-groups, occasional users were the only sub-group in which a majority of users intended to quit its use within the next 6 months: 41% compared to 34% not intending to quit (25% did not know) (Table 4).

Table 4

Intention to quit *IQOS™* use in the next 6 months.
Are you considering stopping IQOS™ use in the next 6 months?	IQOS™ users n = 3002 (%)	Daily users n = 3002 (%)	Occasional Users n = 262 (%)	Exclusive users n = 1907 (%)	Dual users n = 1095 (%)
Yes, I intend to stop within the next 30 days	3	2	16	3	4
Yes, I intend to stop within 6 months but not within 30 days	17	16	25	15	18
No, I do not intend to stop within the next 6 months	65	68	34	69	59
I do not know	15	14	25	13	19

Within a harm reduction approach, two factors are equally important in order to achieve a positive impact on population health. First, the product must present less risk of harm for those who switch completely from cigarette smoking to smoke-free products (17–20). Second, the product must be continuously used in order for consumers to switch, while minimizing its use by unintended audiences, including those who have never smoked, youth, and former smokers.

IQOS™ was introduced in Italy in 2014 (its launch at a national level was completed in 2016), and evaluation of its usage patterns is central to assess its potential to contribute to harm reduction at a population level. This study was conducted on a sample of IQOS™ users in May 2020, to provide insights into IQOS™ use behaviors.

In this survey, IQOS™ users were slightly more male than female, mainly resided in central and southern Italy, had a medium–high level of education, and were mostly in the age range 24–44 years (sex breakdown by age for users in Table 1). We hypothesize that these characteristics also tend to typify early adopters of a new technological and innovative product such as IQOS™ and could change as a greater proportion of smokers in the population adopt the product. Users with a higher level of education are also more likely to be aware of the risks of smoking and that smoke-free products may be a better alternative compared to continued smoking. Data on possible choices of alternatives based on cost were not collected.

Compared to cigarette smoking, whose rate among youth (13–15 years of age) was 21.3% in 2018 [25], only 0.8% of users started using the system at age 16-<18 years and 17.1% at 19–24 years. These data suggest that IQOS™ use is very limited in the underage population, conforming to what was found by independent studies [26–28].

Among IQOS™ users, 91% were daily users, while 9% were occasional users. Within this survey of IQOS™ users, 64% of participants used IQOS™ as their exclusive tobacco product, whereas 32% used IQOS™ with another TNP. Therefore, the majority of subjects had switched completely away from smoking cigarettes to using IQOS™ exclusively. Among IQOS™ users, 89.7% were cigarette smokers and 0.3% were e-cigarette users at the time of IQOS™ adoption, suggesting that the product is mainly used regularly by cigarette smokers who are looking to switch to a potentially less risky product and would otherwise have kept on smoking cigarettes.

Most (95% DU and 88% OU, respectively) were active smokers when they started using IQOS™, while the majority of non-active smokers were former smokers (4.6% of participants in DU and 11.2% in OU). Only 0.6% of participants declared not to have smoked in their lifetime had at the time of IQOS™ initiation, and 7.9% and 0.4% were former cigarette smokers and former e-cig users, respectively, at the time of initiation. These data indicate low potential for initiation and at least limited potential for relapse. It is worth noting that most smokers relapse to cigarettes. [8].

The majority of IQOS™ users (65%) did not intend to quit its use within the next 6 months. Occasional users were the only sub-group in which most users intended to quit its use within the next 6 months (41%, with 34% not intending to quit and 25% who did not know). These results suggest that IQOS™, particularly for daily users, is satisfying consumer’s expectations which is one of the requirements for a successful harm reduction approach.

Cessation is and must remain the primary goal in the fight against smoking. However, for those who would otherwise continue to smoke cigarettes—particularly in Italy, where the rate of smokers was still 26.2% in May 2021 (a total of about 11.3 million smokers) [29]—a harm reduction approach, based on robust scientific evidence should be considered [30], as scientifically substantiated products that do not burn tobacco have the potential to replace cigarettes and contribute to the reduction of smoking-related harms [31–34]. Our findings among Italian IQOS™ users indicate that the use of alternative TNPs has the potential to reduce the number of cigarette smokers in Italy.

Some limitations of the present analysis should be considered. First, participants had to be IQOS™ users, so former users or unsuccessful switchers were not included. Second, the study relied only on self-reported product use. Nevertheless, previous studies have shown that the reliability of self-reported smoking in adults is generally high, suggesting that self-reported data can provide valid estimates of cigarette smoking in the population [35, 36]. However, the reliability of self-reported assessments has not yet been investigated and confirmed for HTPs and other novel TNPs to the same extent and may warrant further investigation. Third, the product launch was rolled out in Milan only in November 2014 and completed at a national level in 2016; therefore, its recent commercialization is a further limitation.

The main strength of the study lies in its design: the combination of CATI and CAWI allowed the survey to reach target users in the age range of 18–80 in a large sample of IQOS™ users, enabling estimation of product-specific prevalence and wider product use, and providing a better understanding of potential of IQOS™ use to contribute to population-level harm reduction.

Acknowledgements

We thank Luigi Godi, M.D., formerly employed by Philip Morris Italia, for his advice and support in the realization of the project and manuscript.

Author contributions

TP and UdLP equally contributed to the study with: conceptualization and methodology; review of study data analysis; writing original draft preparation; writing final manuscript; review & editing.

Funding

The research was conducted by BVA DOXA S.p.A. and sponsored and funded by Philip Morris Italia.

Availability of data and materials

All data generated or analyzed during this study are included in this published article. The complete document regarding the survey will be made available on the website www.agcom.it in agreement with Italian law.

Ethics approval and consent to participate

This study did not require ethical approval. Informed consent was obtained from all subjects involved in the study.

Competing interests

T. Pellegatti is an employee of Philip Morris Italia; U. di Luzio Paparatti is a consultant for Philip Morris Italia.

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Competing interest reported. T. Pellegatti is an employee of Philip Morris Italia; U. di Luzio Paparatti is a consultant for Philip Morris Italia.

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Use of IQOS^TM (a heated tobacco product) in Italy: A cross-sectional survey

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