A randomized, controlled exposure study in adult smokers of full flavor Marlboro cigarettes switching to Marlboro Lights or Marlboro Ultra Lights cigarettes.
Rationale. To date no state-of-the-art clinical study has been conducted to address the question as to whether switching to lower tar cigarettes reduces exposure to smoke constituents in humans. Methods. Randomized, controlled, forced switching study in 225 adult smokers of full flavor Marlboro (MFF) cigarettes for 8 days with a 24-week follow-up. Subjects smoked MFF (a 15-mg Federal Trade Commission (FTC) tar cigarette) at baseline and were randomized to smoke 11-mg Marlboro Lights (ML) or 6-mg Marlboro Ultra Lights (MUL) cigarettes. Biomarkers of exposure to nicotine, 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK), pyrene, CO, benzene, acrolein, and mutagenic substances were measured. Results. In the short-term phase, switching from MFF to ML showed statistically significant decreases in nicotine exposure (-13%) and non-significant increases in CO exposure (+6%), while switching from MFF to MUL showed statistically significant decreases in nicotine (-27%) and CO (-13%) exposure. Both nicotine and CO biomarkers trended similarly in the 24-week follow-up as in the short-term phase. The other biomarkers of cigarette smoke constituents followed the same trend as nicotine at the end of the 24-week follow-up. Conclusions. Switching smokers to lower FTC tar yield cigarettes, on average, reduces nicotine and other biomarkers considered surrogates of tar exposure.
Philip Morris USA Research Center, Clinical Evaluation, 4201 Commerce Road, Richmond, VA 23234, USA. Paul.Mendes@pmusa.com
Paul
P
Mendes
Sunil
S
Kapur
Jingzhu
J
Wang
Shixia
S
Feng
Hans
H
Roethig
D000171:Acrolein / Q000032:analysis; D000280:Administration, Inhalation; D000328:Adult; D000368:Aged; D001554:Benzene / Q000032:analysis; D015415:Biomarkers / Q000032:analysis*; D002248:Carbon Monoxide / Q000032:analysis; D002263:Carboxyhemoglobin / Q000032:analysis; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D019570:Inhalation Exposure; D008297:Male; D008875:Middle Aged; D009538:Nicotine / Q000032:analysis*; D009602:Nitrosamines / Q000032:analysis; D011721:Pyrenes / Q000032:analysis; D012906:Smoke / Q000032:analysis; D012907:Smoking / Q000009:adverse effects*; D013638:Tars / Q000032:analysis; D014028:Tobacco Smoke Pollution / Q000009:adverse effects*
D015415:Biomarkers; D009602:Nitrosamines; D011721:Pyrenes; D012906:Smoke; D013638:Tars; D014028:Tobacco Smoke Pollution; C024746:tobacco tar; D009538:Nicotine; D000171:Acrolein; C016583:4-(N-methyl-N-nitrosamino)-1-(3-pyridyl)-1-butanone; D002248:Carbon Monoxide; D002263:Carboxyhemoglobin; D001554:Benzene