Originally written by Dr. Denis Vitel
In England, the use of low risk products is recommended in smoking cessation programs from doctors and health workers: we hope that soon we will be able to witness the same change all over the world. Prof. Riccardo Polosa Founder of the CoEHAR
Professor Riccardo Polosa discuss in an interview on Medical Tribune the results of his study: heated tobacco products produce fewer exacerbations and better quality of life in COPD patients compared to conventional cigarettes.
Can you present the findings of the recent publication dealing with a population of COPD patients who have (partially or totally) switched combustible cigarettes to HnB products for 3 years?
According to my experience, many COPD patients can’t or don’t want to quit smoking, although It is well known that cigarette smoking is a significant risk factor for COPD. This study, first in its kind, monitored health parameters COPD patients who ceased cigarette consumption after switching to HTPs. At the 3- year follow up, data showed that HTPs use decreased the number of acute exacerbations of COPD by more than 40% and associated improvements in the quality of life and in the ability to exercise. No changes were observed in COPD patients who continued smoking.
Two years ago, we asked you: “is there growing interest in the medical community and in patients associations about risk reduction with e-cigs among COPD patients?” What has changed, if anything, since 2018?
Given that most smoking cessation schemes do not seem to work for the vast majority of COPD smokers and that many COPD patients continue smoking despite their symptoms, the interest of the medical community for alternative approaches is still high and will remain high. Patient with COPD patients face a debilitating pathology and if quitting smoking thanks to HTP is a way to improve their health, I don’t see why not to encourage change. In England, the use of low risk products is recommended in smoking cessation programs from doctors and health workers: we hope that soon we will be able to witness the same change all over the world. Unfortunately, there’s much misinformation concerning the use of heated tobacco products and e-cigarettes, often equated to conventional smoking. Using these products can improve the quality of life of patients with similar diseases. It’s clear that time is giving the possibility to introduce low risk product in therapeutic programs, especially for selected disease: the interest of patient associations and public organizations proves it. The pandemic has not helped reduce smoking-related diseases but it has helped many smokers to think about a healthier lifestyle, sometimes even switching to alternatives of much lower-risk compared to cigarettes.
You applied the same methodology to describe the long-term effects of the substitution of combustible cigarettes by HnB/E-cigs in a COPD population.
[assessment respiratory symptoms, smoking status and conventional cigarette consumption per day (cig/day), number of severe COPD exacerbations in the prior 12 months, FEV1, FVC, expiratory ratio [FEV1/FVC], CAT scores, 6MWD.]
Yes – the same methodologic approach applies. We are talking about the substitution of combustible tobacco cigarettes with combustion-free nicotine delivery technologies. The positive results obtained in these studies are consistently significant and clinically relevant. Most importantly, findings were not unexpected. The conclusion is consistent with what we have learned about tobacco smoke chemical composition and COPD pathogenesis over the last 30-40 yrs, that we are almost certain that substituting tobacco cigarettes with non-combustible sources of nicotine (i.e. vaping or heated tobacco products) would produce significant improvement.
Do you want to comment on the scope, the interest and the limitations of this methodology?
The aim of the study was to evaluate any subjective and objective change in COPD. Avoiding exposure to chemicals generated from the combustion of tobacco cigarettes is known to slow the COPD progression and to improve patients’ health. Nearly 60% of COPD patients using HTPs abstained completely from cigarette smoking throughout the duration of the study, whereas those continuing to smoke (dual users) showed a consistent decline in their daily cigarette consumption. We need more prospective studies on the long-term health impacts of heated tobacco products, but we have observed a decreased in COPD exacerbations , similar to similar to that observed with standard medications. HTP decrease the susceptibility to infections of the respiratory tract.
The study is rather small with a relatively limited follow-up duration of 3-yrs. However, the mantra of dismissing small sample size studies as fundamentally useless by default must cease. In the specific case of our study, results are consistently significant and clinically relevant throughout the whole duration of the study (in spite of the small sample size, suggesting that the possibility of chance findings is highly unlikely). It is over simplistic to suggest that our study – which confirms what might reasonably be predicted – is inadequately powered to draw any conclusions. We already had a conclusion and near certainty about it.
You insisted on the mighty importance of quality of life considering COPD patients. Why? Is is easy for experimentalists to reveal significant differences in quality of life that can not be contested? [go beyond subjectivity, limits of CAT score]
Many of the improvements reported by COPD patients in the study are subjective. However, if we combine these patients reported (i.e. subjective) outcomes with data obtained from the objective evaluations, we have a very powerful story to tell to patients.
After the long term follow-up of populations of roughly 40 COPD patients [5 years follow up e-cigs, 3 years HnB], did you noticed, did you learned something about the subpopulation called “dual users”? (that partly substitutes the combustible cigarette)
Dual users are people who combine the use of low risk products with conventional cigarettes. During these studies, dual users substantially decreased the number of cigarette smoke daily; in these patients we observed improvements in subjective as well as objective respiratory outcomes that were similar to those observed in those who completely stopped smoking.
The gathering of data about the substitution of combustible cigarettes by alternative nicotine delivery devices is an “emerging body of knowledge”, still highly controversial.
We pioneered this research space and we agree that the body of knowledge of harm reversal at individual level is still in its early stage. But we see no controversy here. There is not a single study confuting the evidence that switching from combustible to noncombustible sources of nicotine results in health benefits. The interest in tobacco harm reduction is growing and the quality of its research is improving. At CoEHAR we are coordinating a number of ground-breaking research programs aimed at the full elucidation of benefits and risks of alternative nicotine delivery systems. So watch this space.
What do we need for more certainty: longer studies including larger populations? More knowledge about the molecular and cellular effects of the substitution (inflammation, DNA damage, oxidative stress, etc.)
Multicenter follow-up studies of longer duration are now needed to substantiate and elucidate the emerging role of combustion free nicotine delivery technologies for smoking cessation, relapse prevention and/or harm reversal in smoking COPD patients who have switched to these products.
The negative impact of tobacco smoke chemicals on cell systems has been known for decades and it is therefore predictable that substitution of tobacco cigarettes with non-combustible sources of nicotine (i.e. vaping or heated tobacco products) will produce significant improvement. Also beware for the potential for misinformation from poorly designed experimental studies. However, existing preclinical (i.e. in vitro systems and animal models) studies can be uninformative or even misleading due to poor experimental design that do not mimic normal condition of use and lack of robust methodology standards.