Assessment of the reduction in levels of exposure to harmful and potentially harmful constituents in Japanese subjects using a novel tobacco heating system compared with conventional cigarettes and smoking abstinence: A randomized controlled study in confinement.
Smoking conventional cigarettes (CCs) exposes smokers to harmful and potentially harmful constituents (HPHCs). The Tobacco Heating System 2.2 (THS 2.2), a candidate modified risk tobacco product, was developed to reduce or eliminate the formation of HPHCs, while preserving as much as possible the taste, sensory experience, nicotine delivery profile and ritual characteristics of CC. This randomized, controlled, open-label study in confinement for 5 day exposure aimed to demonstrate the reduction in exposure to selected HPHCs, to assess nicotine uptake and subjective effects, in participants switching to THS 2.2 (n = 80) compared to participants continuing smoking CCs (n = 40) and abstaining from smoking (n = 40). The subjects were randomized according to sex and daily CC consumption. The levels of biomarkers of exposure to HPHCs were significantly reduced in participants switching to THS 2.2, compared to CC use. More importantly, the magnitude of exposure reduction observed was close to that which was seen in participants who abstained from smoking for 5 days, while nicotine uptake was maintained. Reduction in urge-to-smoke was comparable between THS and CC groups, however THS 2.2 was slightly less satisfactory than CCs. The new, alternative tobacco product THS 2.2 was well tolerated.
Philip Morris International R&D, Philip Morris Products S.A. (Part of Philip Morris International Group of Companies), Neuchâtel, Switzerland. Electronic address: Christelle.haziza@pmi.com.
Christelle
C
Haziza
Philip Morris International R&D, Philip Morris Products S.A. (Part of Philip Morris International Group of Companies), Neuchâtel, Switzerland.
Guillaume
G
de La Bourdonnaye
Philip Morris International R&D, Philip Morris Products S.A. (Part of Philip Morris International Group of Companies), Neuchâtel, Switzerland.
Sarah
S
Merlet
Philip Morris International R&D, Philip Morris Products S.A. (Part of Philip Morris International Group of Companies), Neuchâtel, Switzerland.
Muriel
M
Benzimra
Philip Morris International R&D, Philip Morris Products S.A. (Part of Philip Morris International Group of Companies), Neuchâtel, Switzerland.
Jacek
J
Ancerewicz
Philip Morris International R&D, Philip Morris Products S.A. (Part of Philip Morris International Group of Companies), Neuchâtel, Switzerland.
Andrea
A
Donelli
Philip Morris International R&D, Philip Morris Products S.A. (Part of Philip Morris International Group of Companies), Neuchâtel, Switzerland.
Gizelle
G
Baker
Philip Morris International R&D, Philip Morris Products S.A. (Part of Philip Morris International Group of Companies), Neuchâtel, Switzerland.
Patrick
P
Picavet
Philip Morris International R&D, Philip Morris Products S.A. (Part of Philip Morris International Group of Companies), Neuchâtel, Switzerland.
Frank
F
Lüdicke
D000328:Adult; D000368:Aged; D066300:Electronic Nicotine Delivery Systems / Q000295:instrumentation*; D005260:Female; D006361:Heating; D006801:Humans; D007564:Japan; D008297:Male; D008875:Middle Aged; D012907:Smoking / Q000009:adverse effects*; D062789:Tobacco Products / Q000009:adverse effects*; D055815:Young Adult
Biomarkers of exposure; Harmful and potentially harmful constituents; Modified risk tobacco product; Randomized study; Reduced risk product; Smoking; Smoking abstinence; Tobacco heating system