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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.
Conclusion: The 4-mg nicotine lozenge and 4-mg nicotine gum had comparable safety profiles in these patients with label-restricted medical conditions.
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http://dx.doi.org/10.1016/j.clinthera.2005.10.008 | DOI Listing |
Front Chem
November 2024
Zhengzhou Tobacco Research Institute of CNTC, Zhengzhou, Henan, China.
Understanding the puff-by-puff delivery mechanisms of key components of heated tobacco products is critical to developing product designs. This study investigates the puff-by-puff release patterns of key components in Natural Smoke Cigarettes (NSCs), which are designed to deliver nicotine without combustion by reducing oxygen content, utilizing a 30-s puff interval, a 2-s puff duration, and a 55 mL puff volume to simulate realistic smoking conditions. By establishing models to analyze the variation of nicotine, glycerol, 1,2-propylene glycol (PG), and water in different functional sections of the cigarette under controlled smoking conditions.
View Article and Find Full Text PDFPsychopharmacology (Berl)
November 2024
JT International (JTI) SA, 8 Rue Kazem Radjavi, 1202, Geneva, Switzerland.
Addiction
November 2024
Department of Health Behavior, Roswell Park Comprehensive Cancer Center, Buffalo, NY, USA.
Cutan Ocul Toxicol
December 2024
Optometry Department, College of Applied Medical Sciences, King Saud University, Riyadh, Saudi Arabia.
Purpose: To investigate the immediate impact of nicotine consumption on Retinal Nerve Fiber Layer (RNFL) thickness in healthy young individuals, comparing nicotine gum and electronic cigarette (vaping) as delivery methods.
Materials And Methods: Twenty participants underwent RNFL measurements at baseline, 30, and 60 minutes after consuming 4 mg of nicotine, based on product labeling and specifications. Measurements were obtained using optical coherence tomography (OCT) (Topcon 3D OCT-1 Maestro System).
Exp Neurol
December 2024
Department of Animal Biology, School of Biology, College of Science, University of Tehran, Tehran, Iran. Electronic address:
Ischemic stroke is followed by an increased susceptibility to bacterial infections, which exacerbate histological stroke outcome, neurological deficits and memory impairment due to increased neuroinflammation and neurotransmitter dysfunction. Pharmacological activation of nicotinic acetylcholine receptors was suggested to mitigate brain inflammatory responses in ischemic stroke. The functional responses associated with nicotinic acetylcholine receptor activation were unknown.
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