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Zyban

Clinical Pharmacology
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Clinical Pharmacology

Use In Patients With Chronic Obstructive Pulmonary Disease (COPD): ZYBAN was evaluated in a randomized, double-blind, comparative study of 404 patients with mild-to-moderate COPD, defined as FEV1≥ 35%, FEV1/FVC≤ 70% and a diagnosis of chronic bronchitis, emphysema and/or small airways disease. Patients aged 36 to 76 years were randomized to ZYBAN 300 mg/day (n = 204) or placebo (n = 200) and treated for 12 weeks. Treatment with ZYBAN was initiated at 150 mg/day for 3 days while the patient was still smoking and increased to 150 mg twice daily for the remaining treatment period. Abstinence from smoking was determined by patient daily diaries and verified by carbon monoxide levels in expired air. Quitters are defined as subjects who were abstinent during the last 4 weeks of treatment. Table 3 shows quit rates in the COPD Trial.

Table 3. COPD Trial: Quit Rates by Treatment Group


4-Week Abstinence Period Treatment Groups
Placebo
(n = 200)
%
(95% CI)
ZYBAN
300 mg/day
(n = 204)
%
(95% CI)
Weeks 9 through 12 12%
(8-16)
22%*
(17-27)
*Significantly different from placebo (p< 0.05).
Brand Name: Zyban
Generic Name: Bupropion Hcl
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