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Abstract
Background: Smoking cessation outcomes are calculated as the probability of abstinence at follow-up
among all enrolled smokers, but it is also useful to estimate the probability of success
for those who experienced success or failure at earlier time points.
Objectives: The primary aims were to estimate the probability of maintaining abstinence through
week 10 among subjects who were abstinent at week 2, and to assess the effect of active
treatment with a nicotine patch. We also examined outcomes at week 6 and, among subjects
who smoked during the first 2 weeks of treatment, the probability of reestablishing
abstinence later, as well as the effect of active treatment on this outcome.
Methods: We analyzed pooled data from 2 previously published, parallel, double-blind studies
in which subjects were initially randomized to receive an active nicotine patch (starting
at 21 mg) or a placebo patch. Subjects randomized to active treatment followed a double-blind
step-down dosing regimen: 24-h/21-mg patches for the first 6 weeks of treatment, followed
by 14- and 7-mg patches for successive 2-week periods. Biochemically verified abstinence
(exhaled carbon monoxide ≤8 ppm) was assessed during laboratory visits.
Results: Most subjects were white (94.8%) and female (61.6%), with a mean (SD) age of 43.1
(10.2) years. Subjects had been smoking for a mean of 24.5 (10.2) years and smoked
a mean of 30.6 (10.4) cigarettes per day. In both the nicotine (n = 249) and placebo
(n = 253) groups, all subjects who were abstinent during the first 2 weeks had a high
probability of maintaining abstinence through week 10, but subjects treated with the
active patch were significantly more likely to remain abstinent (active: 79.8% [67/84],
placebo: 52.6% [20/38]; relative risk [RR] = 1.52 [95% CI, 1.10–2.09]). Also, at week
6, subjects receiving active treatment had a greater chance of remaining abstinent
(active: 94.3% [82/87], placebo: 78.0% [32/41]; RR = 1.21 [95% CI, 1.02–1.43]). To
assess the effect of treatment on recovery from smoking lapses, we examined the probability
of abstinence during week 10 among subjects who smoked during the first 2 weeks of
treatment. Among them, treatment was associated with a greater probability of later
success: 31.4% (50/159) of those treated with the active patch and 12.5% (26/208)
of those receiving placebo were abstinent at week 10 (RR = 2.52 [95% CI, 1.64–3.85]).
Similar results were observed at week 6 (49.4% [80/162] vs 21.2% [45/212]; RR = 2.33
[95% CI, 1.72–3.15]).
Conclusions: More than two thirds (71.3%) of subjects who were abstinent 2 weeks into a quit
attempt maintained that abstinence through the end of 10 weeks of treatment. Use of
a nicotine patch was significantly associated with maintaining abstinence and with
recovering abstinence after an early lapse.
Key words
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Article info
Publication history
Accepted:
July 21,
2009
Identification
Copyright
© 2009 Excerpta Medica Inc. All rights reserved. Published by Elsevier Inc.
