Safety profile of a nicotine lozenge compared with that of nicotine gum in adult smokers with underlying medical conditions: a 12-week, randomized, open-label study.
BACKGROUND
Nicotine polacrilex lozenges deliver 25% to 27% more nicotine compared with equivalent doses of nicotine polacrilex gum. The increased nicotine exposure from the lozenge has raised questions about the relative safety of the lozenge and gum.


OBJECTIVE
The objective of this study was to compare the safety profiles of the 4-mg nicotine lozenge and 4-mg nicotine gum in smokers with selected label-restricted diseases.


METHODS
This was a multicenter, randomized, open-label study in adult smokers with heart disease, hypertension not controlled by medication, and/or diabetes mellitus. Patients were randomized in a 1:1 ratio to receive the 4-mg nicotine lozenge or 4-mg nicotine gum. Safety assessments were made at baseline and at 2, 4, 6, and 12 weeks after the start of product use.


RESULTS
Nine hundred one patients were randomized to treatment, 447 who received the lozenge and 454 who received the gum (safety population). The majority were women (52.7%). Patients' mean age was 53.9 years, their mean weight was 193.9 pounds, and they smoked a mean of 25.2 cigarettes per day at baseline. Five hundred fifty-three patients, 264 taking the lozenge and 289 taking the gum, used the study product for > or =4 days per week during the first 2 weeks (evaluable population). The nicotine lozenge and nicotine gum were equally well tolerated, despite increased nicotine exposure from the lozenge. The incidence of adverse events in the 2 groups was similar during the first 2 weeks of product use (evaluation population: 55.3% lozenge, 54.7% gum), as well as during the entire study (safety population: 63.8% and 58.6%, respectively). Stratification of patients by sex, age, extent of concurrent smoking, extent of product use, and severity of adverse events revealed no clinically significant differences between the lozenge and gum. The most common adverse events were nausea (17.2% and 16.1%; 95% CI, -3.7 to 6.0), hiccups (10.7% and 6.6%; 95% CI, 0.5 to 7.8), and headache (8.7% and 9.9%; 95% Cl, -5.0 to 2.6). Serious adverse events were reported in 11 and 13 patients in the respective groups. Fewer than 6% of patients in either group were considered by the investigator to have a worsening of their overall disease condition during the study. The majority of patients (>60%) experienced no change in their disease status from baseline.


CONCLUSIONS
The 4-mg nicotine lozenge and 4-mg nicotine gum had comparable safety profiles in these patients with label-restricted medical conditions.
Marsh
Howard S
HS
GlaxoSmithKline Consumer Healthcare, Parsippany, NJ 07054, USA.
Dresler
Carolyn M
CM
Choi
Jae H
JH
Targett
Darren A
DA
Gamble
Michael L
ML
Strahs
Kenneth R
KR
D000465:Algorithms; D000697:Central Nervous System Stimulants / Q000008:administration & dosage / Q000627:therapeutic use*; D002638:Chewing Gum; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced; D006331:Heart Diseases / Q000150:complications / Q000473:pathology; D006801:Humans; D006973:Hypertension / Q000150:complications / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009422:Nervous System Diseases / Q000139:chemically induced; D009538:Nicotine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D011109:Polymethacrylic Acids / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011145:Polyvinyls / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D012140:Respiratory Tract Diseases / Q000139:chemically induced; D016540:Smoking Cessation / Q000379:methods; D013607:Tablets; D013997:Time Factors; D061485:Tobacco Use Cessation Devices; D014029:Tobacco Use Disorder / Q000150:complications / Q000473:pathology / Q000628:therapy*; D014481:United States
D000697:Central Nervous System Stimulants; D002638:Chewing Gum; D011109:Polymethacrylic Acids; D011145:Polyvinyls; D013607:Tablets; D009538:Nicotine