title: Reduced exposure evaluation of an Electrically Heated Cigarette Smoking System. Part 6: 6-Day randomized clinical trial of a menthol cigarette in Japan.
abstract: A randomized, controlled, open-label, parallel-group, single-center study to determine biomarkers of exposure to 12 selected harmful and potentially harmful constituents (HPHC) in cigarette smoke, excretion of mutagenic material in urine, and serum Clara cell 16-kDa protein (CC16) in 102 male and female Japanese subjects who smoked Marlboro Ultra Lights Menthol cigarettes (M4J(M); 4 mg tar and 0.3mg nicotine) at baseline. Subjects were randomized to continue smoking M4J(M), or switch to smoking either the Electrically Heated Cigarette Smoking System menthol cigarette (EHCSS-K6(M); 5mg tar and 0.3mg nicotine) or the Lark One menthol cigarette (Lark1(M); 1mg tar and 0.1mg nicotine), or to no-smoking. The mean decreases from baseline to Day 5/6 were statistically significant (p ≤ 0.05) for exposure to 10 of 12 cigarette smoke HPHC including the primary endpoint (carbon monoxide) and urinary excretion of mutagenic material in the EHCSS-K6(M) group (-12.3% to -83.4%). Smaller, but statistically significant reductions (p ≤ 0.05) occurred in the Lark1(M) group (-3.3% to -35.2%), with the exception of urinary mutagens. The largest mean reductions (all p ≤ 0.05) in exposure to cigarette smoke HPHC and excretion of mutagenic material occurred in the no-smoking group (-1.4% to -93.6%). Serum CC16, an indicator of lung epithelial injury, was not significantly different between groups.
authors.affiliation: Philip Morris International R&D, Philip Morris Products SA, Quai Jeanrenaud 5, 2000 Neuchâtel, Switzerland. Anthony.Tricker@pmintl.com
authors.forename: Anthony R
authors.initials: AR
authors.lastname: Tricker
authors.forename: Shigeto
authors.initials: S
authors.lastname: Kanada
authors.forename: Kohji
authors.initials: K
authors.lastname: Takada
authors.forename: Claire
authors.initials: C
authors.lastname: Martin Leroy
authors.forename: Dirk
authors.initials: D
authors.lastname: Lindner
authors.forename: Matthias K
authors.initials: MK
authors.lastname: Schorp
authors.forename: Ruth
authors.initials: R
authors.lastname: Dempsey
mesh_terms: D000328:Adult; D015415:Biomarkers / Q000097:blood / Q000652:urine; D002263:Carboxyhemoglobin / Q000032:analysis; D004560:Electricity; D005260:Female; D006358:Hot Temperature; D006801:Humans; D019570:Inhalation Exposure / Q000009:adverse effects* / Q000032:analysis; D007564:Japan; D008297:Male; D008875:Middle Aged; D012907:Smoking / Q000009:adverse effects / Q000097:blood* / Q000652:urine*; D013997:Time Factors; D062789:Tobacco Products / Q000032:analysis* / Q000633:toxicity; D014028:Tobacco Smoke Pollution / Q000009:adverse effects / Q000032:analysis* / Q000517:prevention & control; D055815:Young Adult
chemical_list: D015415:Biomarkers; D014028:Tobacco Smoke Pollution; D002263:Carboxyhemoglobin