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A 12-Month, Randomized, Controlled Study to Evaluate Exposure and Cardiovascular Risk Factors in Adult Smokers Switching From Conventional Cigarettes to a Second-Generation Electrically Heated Cigarette Smoking System

From Philip Morris USA, Richmond, Virginia.

This randomized, controlled, forced-switching, open-label, parallel-group study in 97 adult male and female smokers of conventional cigarettes evaluated biomarkers of tobacco smoke exposure and cardiovascular risk factors. After baseline measurements, smokers were either switched to a second-generation electrically heated cigarette smoking system (EHCSS) or continued smoking conventional cigarettes for 12 months. Biomarkers of exposure and cardiovascular risk factors were measured at 0.5, 1, 2, 3, 4, 5, 6, 9, and 12 months. There was a rapid and sustained reduction in all biomarkers of exposure after switching to the EHCSS, with statistically significant reductions from baseline in nicotine equivalents (-18%), plasma cotinine (-16%), total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (-73%), total 1-hydroxypyrene (-53%), urine mutagenicity (-52%), 4-aminobiphenyl hemoglobin adducts (-43%), carboxyhemoglobin AUC_{7-23 h} (-80%), and 3-hydroxypropylmercapturic acid (-35%). These reductions in exposure in the EHCSS group were associated with statistically significant and pathophysiologically favorable changes in several cardiovascular risk factors, including white blood cell count (-0.78 x 10³/µL), hemoglobin (-0.16 g/dL), hematocrit (-0.44%), urine 11-dehydrothromboxane B₂ (-374 ng/24 h), and high-density lipoprotein cholesterol (+5 mg/dL).

Key Words: Biomarkers • exposure • cardiovascular risk factors • EHCSS • potential reduced-exposure tobacco product

Address for correspondence: Hans J. Roethig, MD, PhD, FCP, FFPM, Philip Morris USA Inc, Research Center, 4201 Commerce Road, Richmond, VA 23234; e-mail: hans-juergen.roethig{at}pmusa.com.