Safety of Nicotine Polacrilex Gum Used by 3,094 Participants in the Lung Health Study
| Autor: | Mitchell A. Nides, Kathleen Daniels, Robert P. Murray, John E. Connett, William C. Bailey, James P. Kiley, Wendy Bjornson, Karole Kurnow |
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| Rok vydání: | 1996 |
| Předmět: |
Pulmonary and Respiratory Medicine
medicine.medical_specialty COPD Throat irritation Side effect business.industry medicine.medical_treatment Critical Care and Intensive Care Medicine medicine.disease law.invention Clinical trial Randomized controlled trial Nicotine gum law Internal medicine medicine Physical therapy Smoking cessation medicine.symptom Cardiology and Cardiovascular Medicine Nicotine polacrilex business |
| Zdroj: | Chest. 109:438-445 |
| ISSN: | 0012-3692 |
| Popis: | Study objective To assess cardiovascular conditions and other side effects associated with the use of nicotine polacrilex (NP), 2 mg. Design 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. Intervention 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 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. |
| Databáze: | OpenAIRE |
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