The 13th World Conference on Tobacco OR Health

Objective: In Russia, nicotine replacement therapy (NRT), despite its proven efficacy and over-the-counter status, is still regarded as “dangerous”, both by smokers and health professionals. To prove its safety and tolerability, we studied dynamics of main health status parameters and adverse effects in male smokers trying to quit using NRT.

Methods: An open, randomized study was conducted to examine effectiveness and safety of nicotine gum/inhaler in smoking cessation/reduction. 169 relatively healthy male smokers aged 18-60 years were randomly assigned to free choice vs admission of nicotine gum (2/4 mg) or inhaler (10 mg) (Nicorette, Pharmacia Upjohn). At baseline, all participants smoked 15+ cigs/d, for at least 3 years. The intervention phase lasted for 3 months; follow-up evaluations were made at 3, 6 and 12 months after NRT initiation.

Results: 12-month rates of cessation, reduction, and CO-verified reduction were 19.7%, 35.5%, and 29.1%, respectively. Self-evaluation of health remained “satisfactory” in most participants, being slightly better in quitters. Mean blood pressure was 127.9/83.3 and 128.4/83.8 mm Hg in quitters and non-quitters, respectively (NS); mean heart rate – 72.2 vs 75.9 bpm (p<0.05), respectively. Body weight increased by 3.0 and 0.4 kg, but, because non-quitters were heavier at baseline, the final difference was not significant: 83.7 kg in quitters and 82.9 kg in non-quitters. Most adverse effects were local, mild, short-lived, and not leading to therapy discontinuation. Both Russian health professionals and general public should be informed that NRT-assisted cessation is safe and does not affect quitters' health.