SAFETY OF NICOTINE POLACRILEX GUM USED BY 3,094 PARTICIPANTS IN THE LUNG HEALTH STUDY

Study objective: To assess cardiovascular conditions and other side ef fects associated with the use of nicotine polacrilex (NP), 2 mg. Desig n: A multicentered randomized control trial of early intervention for the prevention of COPD. Setting: Ten university medical centers in the United States and Canada. Participants: Adult smoking volunteers with evidence of early COPD; 3,923 in intervention and 1,964 controls. Int ervention: Smoking cessation program, including NP. Measurements: Data on hospitalizations were collected annually. Data on reported NP side effects were collected at 4-month intervals for intervention particip ants. Results: The rates of hospitalization for cardiovascular conditi ons and cardiovascular deaths during the 5 years of the study were not related to use of NP, to dose of NP, or to concomitant use of NP and cigarettes. About 25% of NP users reported at least one side effect, b ut most were very minor and transient. Side effects associated with di scontinuance of NP in 5% or more of users included headache, indigesti on, mouth irritation, mouth ulcers, and nausea. There was no evidence that concomitant use of NP and cigarettes was associated with elevated rates of reported side effects. Participants in the smoking cessation intervention who received intensive levels of instruction, and monito ring of NP use (initially at 12 meetings during 3 months) appeared to report significantly lower rates of side effects (dizziness, headache, and throat irritation) than control participants, presumed to have le ss instruction and monitoring. Conclusions: NP, as used in the Lung He alth Study, appears to be safe and unrelated to any cardiovascular ill nesses or other serious side effects.