Tolerability of concurrent use of nicotine gum and smoking in healthy volunteers.
Although nicotine replacement therapy (NRT) is mainly licensed as an aid for smoking cessation, many smokers alternate NRT with cigarettes. This study evaluated the cardiovascular tolerability of nicotine gum plus smoking. This open, three-way, randomized, multiple-dose, crossover study involved 19 healthy adult volunteer smokers. Three treatments (placebo gum+cigarette vs. nicotine 4-mg gum+unlit cigarette vs. nicotine 4-mg gum+cigarette) were each administered hourly seven times during one study day. Plasma nicotine, ECG variables (ST60 and ST(slope)), heart rate, and blood pressure were measured at rest and during/after 5 min exercise tests. Mean plasma nicotine levels were higher with gum plus smoking than with either gum or smoking alone. After the final administration, mean levels with gum plus smoking were 39.5 (range 27.6-54.4) ng/ml vs. 19.6 (11.8-30.1) ng/ml with gum and 22.6 (6.6-36.6) ng/ml with smoking alone. No signs of myocardial ischaemia were observed during concomitant use of gum plus smoking, despite high plasma nicotine levels. Decreases of ST60 and ST(slope) were observed in all treatment groups during exercise but were asymptomatic. Concomitant gum plus smoking did not increase the incidence of extrasystoles or arrhythmia. No serious adverse events occurred during the study. In conclusion, there were no signs of myocardial ischaemia during multiple submaximal exercise tests in healthy volunteers while smoking and using nicotine 4-mg gum.
Stahl
M M
MM
Department of Clinical Pharmacology, Pharmacia Consumer Healthcare, Lund, Sweden.
Wohlfart
B
B
Pahlm
O
O
D000328:Adult; D001794:Blood Pressure / Q000187:drug effects; D002248:Carbon Monoxide / Q000032:analysis; D002638:Chewing Gum / Q000706:statistics & numerical data*; D018592:Cross-Over Studies; D004334:Drug Administration Schedule; D004361:Drug Tolerance; D005260:Female; D006304:Health Status; D006339:Heart Rate / Q000187:drug effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D009538:Nicotine / Q000008:administration & dosage* / Q000097:blood / Q000494:pharmacology; D012907:Smoking / Q000453:epidemiology*; D016540:Smoking Cessation / Q000379:methods* / Q000706:statistics & numerical data; D000074606:Smoking Prevention; D014029:Tobacco Use Disorder / Q000453:epidemiology* / Q000517:prevention & control
D002638:Chewing Gum; D009538:Nicotine; D002248:Carbon Monoxide