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Safety of Nicotine Polacrilex Gum Used by 3,094 Participants in the Lung Health
Study
Robert P. Murray, PhD; William C. Bailey, MD, FCCP; Kathleen Daniels, MS; Wendy
M. Bjornson, MPH; Karole Kurnow, MS; John E. Connett, PhD; Mitchell A. Nides,
PhD; and James P. Kiley, PhD; for the Lung Health Study Research Group
February 1996
Study objective:
To assess cardiovascular conditions and other side effects associated with the
use of nicotine polacrilex (NP), 2 mg.
Design:
A multi-centered 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.
Intervention:
Smoking cessation program, including NP.
Measurement:
Data on hospitalizations were collected annually. Data on reported NP side
effects were collected at 4-month intervals for intervention participants.
Results:
The rates of hospitalization for cardiovascular conditions 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, but most were very minor and transient. Side
effects associated with discontinuance of NP in 5% or more of users included
headache, indigestion, 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 monitoring 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 less Instruction and monitoring.
Conclusions:
NP, as used in the Lung Health Study, appears to be safe and unrelated to any
cardiovascular illnesses or other serious side effects.
Contact us for more information on this study.
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