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Table 8 Complete abstinence from week 2 at each visit

From: Pharmacokinetics, safety and efficacy from randomized controlled trials of 1 and 2 mg nicotine bitartrate lozenges (Nicotinell®)

Time since treatment started

6 weeks

12 weeks

26 weeks

French study (FTDN 4 to7)

Placebo n = 222, Nicotinell Lozenge 1 mg n = 211

Completely abstinent

active

48

22.7%

28

13.3%

25

11.8%

N (%)

placebo

32

14.4%

20

9.0%

18

8.1%

OR [95% CI]

 

1.72 [1.05–2.80]

1.47 [0.82–2.65]

1.48 [0.78–2.79]

Statistical significance

 

p = 0.03

p = 0.199

p = 0.227

USA study (FTND ≥ 6)

 

Placebo n = 230, Nicotinell Lozenge 1 mg n = 230

Completely abstinent

active

19

8.3%

11

4.8%

8

3.5%

N (%)

placebo

7

3.0%

3

1.3%

2

0.9%

OR [95% CI]

 

2.87 [1.18–6.97]

3.80 [1.05–13.80]

4.11 [0.83–19.55]

Statistical significance

 

p = 0.02

p = 0.03

p = 0.06

  1. Completely abstinent = subjects declaring not to smoke + exhaled-breath CO <10 ppm