• Christopher J Shepperd, Nik Newland, Alison Eldridge, Linsey Haswell, Frazer Lowe, Ermioni Papadopoulou, Oscar Camacho, Christopher J Proctor, Don Graff, and Ingo Meyer.
• British American Tobacco, Group Research and Development, Regents Park Road, Southampton SO15 8TL, UK.
• Regul. Toxicol. Pharmacol. 2015 Jul 1; 72 (2): 273-91.

BackgroundDevelopment of cigarettes that reduce exposure to harmful smoke constituents is a suggested tobacco harm reduction strategy, but robust methods for measurement of change are required. We investigated whether changes in biomarkers of exposure (BoE), effective dose (BoED) and biological effect (BoBE) could be detected after switching from conventional cigarettes to a reduced-toxicant-prototype cigarette (RTP).MethodsRegular smokers of 6-8mg ISO tar yield cigarettes were recruited in Hamburg, Germany, and supplied with a conventional 7mg ISO tar yield cigarette for 2weeks then switched to the same cigarette with a different tipping paper (control) or the RTP for 6months. Subjects smoked mostly at home and attended five residential clinic visits where urine and blood samples were collected for analysis. Primary endpoints were changes in specific biomarker levels compared with non-smoker background levels. Changes in daily cigarette consumption were also investigated.ResultsBoE levels in controls generally increased over the study period, whereas most BoE and all BoED significantly declined in RTP smokers. Most BoBE data were similar across groups and/or too variable within individuals to detect changes. Increased daily cigarette consumption was affected by supply of free cigarettes, perceived shorter smoking time per cigarette than usual brands, and perceived reduced harm.ConclusionsDespite increased cigarette consumption, reductions in BoE and BoED were detectable.Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

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