Peer-Reviewed Publications

      Reduced exposure evaluation of an Electrically Heated Cigarette Smoking System. Part 6: 6-day randomized clinical trial of a menthol cigarette in Japan

      Tricker, A. R.; Kanada, S.; Takada, K.; Martin Leroy, C.; Lindner, D.; Schorp, M. K.; Dempsey, R.
      Published
      Aug 22, 2012
      DOI
      10.1016/j.yrtph.2012.08.007
      PMID
      22951347
      Link to publication
      Topic
      Summary

      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 (M4JM; 4 mg tar and 0.3 mg nicotine) at baseline. Subjects were randomized to continue smoking M4JM, or switch to smoking either the Electrically Heated Cigarette Smoking System menthol cigarette (EHCSS-K6M; 5 mg tar and 0.3 mg nicotine) or the Lark One menthol cigarette (Lark1M; 1 mg tar and 0.1 mg 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-K6M group (-12.3% to -83.4%). Smaller, but statistically significant reductions (p≤0.05) occurred in the Lark1M 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.

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      Reduced Risk Products ("RRPs”) is the term we use to refer to products that present, are likely to present, or have the potential to present less risk of harm to smokers who switch to these products versus continuing smoking. PMI has a range of RRPs in various stages of development, scientific assessment and commercialization. All of our RRPs are smoke-free products that deliver nicotine with far lower quantities of harmful and potentially harmful constituents than found in cigarette smoke.