P Tonnesen.2009

Smoking reduction

Philip Tønnesen, M.D.,

Department of Pulmonary Medicine

Copenhagen, Denmark

P Tonnesen.2009

Tobacco control

Prevention Smoking cessation

Smoking reduction

P Tonnesen.2009

Nicotine replacement

• 17 % of NRT is used for other than smoking cessation! i.e.

• 60 % use NRT < 2 weeks

• 40 % no instruction (GP or pharmacit)

• Temporary abstinence: during work, travel

• Smoking reduction

P Tonnesen.20090%

20%

40%

60%

80%

100%

Smokers

Stops today 4%

Wants to stop29%

Reduces now17%

Wants to reduce16%

Smokers in the NetherlandsNew smokers to reach with Reduction to Stop

Happy smokers34%

Unhappy (ambivalent) smokers 66%

100%

80%

60%

40%

20%

0%

P Tonnesen.2009

Smoking Reduction

Rationale

1. Aimed for smokers low in motivation to quit / unable to quit

2. Induction of permanent change in smoking habit

3. Compensation not 100%

4. Will not interfere with smoking cessation

P Tonnesen.2009

Smoking Reduction

• Cigarettes + NRT use

Definition: “arbitrary”

Cigarettes/day < 50 % of entry numbers

plus any decrease in CO (1 ppm or >)

P Tonnesen.2009

Cessation-induction

Ready to reduce smoking

NRT increases reduction

Self-efficacy increased

Intention to quit increased

Increased probability of a quit attempt

Increased abstinence

NRT prior to quittingdecreases relapse

Reducing prior to quittingdecreases relapse

P Tonnesen.2009

Clinical Studies Study Max trt

timeNRT Subjects Investigator(s)

96NNIN016 18 Inhaler 400 Bolliger, Zellweger

98NNIN027 12 Inhaler 429 Rennard, Glover, Muramoto

98NNCG014 12 Gum (2+4)

411 Tønnesen

980CHC-1013-028 12 Gum (4) 364 Batra, Klingler

98NNCG017 12 Gum (2+4)

436 Woodbaker, Southcott, Saunders

980CHC-9021-0013 9 Gum (2+4)

385 Haustein, Batra

P Tonnesen.2009

Gum and Inhalator Increase the Likelihood of Successful Sustained Reduction (2 Inhaler, 4 Gum

studies)

0

5

10

15

20

25

4 months 12 months

Active Gum Placebo Gum

Active Inhaler Placebo Inhaler%

Sustained Smoking Reduction From Week 6 (at least 50% reduction, verified by a lowered CO)

*

*

* p<0.001*

*

P Tonnesen.2009

Gum and Inhalator Increase the Likelihood of Successful Cessation (2 Inhaler, 4 Gum studies)

0123456789

10

4 months 12 months

Active Gum Placebo Gum

Active Inhaler Placebo Inhaler%

Point Prevalence Cessation Rates (complete cessation, verified by a CO < 10 ppm)

**

*

*

* p<0.001

P Tonnesen.2009

Smoking reductionWennike, Tønnesen et al. Addiction 2003

• 411 smokers

• 24 cigarettes/day

• Motivation to reduce on 10-cm VAS: 9

• Motivation to quit on 10-cm VAS: 5

• Nicotine gum for up to 12 months

P Tonnesen.2009

Smoking reductionWennike, Tønnesen et al. Addiction 2003

Reduction (sustained):

Active Placebo

4-months 14 % 5 % (p<0.002)

1-year 8.8 % 1.5 % (p<0.001)

2-years 6.3 % 0.5 % (p<0.001)

P Tonnesen.2009

Smoking reductionWennike, Tønnesen et al, Addiction 2003

Cessation (point):

Active Placebo

4 months 6.3 % 0.5 % (p<0.001)

1-year 11.2 % 3.9 % (p<0.005)

2-years 9.3 % 3.4% (p<0.01)

P Tonnesen.2009

Motivation to quit

”Has your participation in the trial changed your attitude towards quitting smoking?” Subjects attending the visit after 2 years. No, not at

all Yes, I am more

interested in quitting

Yes, I am less interested in

quitting

I don't know

12 months (n=176) 31 % 66 % 1 % 2 % 24 month (n =167) 31 % 67 % 1 % 2 %

P Tonnesen.2009

Smoking cessation/reduction in COPD (Tønnesen et al.In press)

• 370 COPD patients

• Age :62 years

• FEV1: 1.57 (56 % predicted)

• Cigarettes/day: 20

• FTND: 6.4

• High – low support, NRT – placebo 12 weeks

P Tonnesen.2009

Smoking reduction in COPD

NRT versus placebo:

6 months reduction rate: 21 % vs 15 %

12 months reduction rate: 12 % vs 13 %

P Tonnesen.2009

Smoking cessation in COPD

NRT versus placebo:

6 months quit rate: 23 % vs 10 %

12 months quit rate: 17 % vs 10 % (OR 2.0)

P Tonnesen.2009

Reduction to quit with NRT OTC

• 3297 smokers in US

• 2-mg, 4-mg nicotine gum or placebo

• The first 8 weeks gardually reduce number of CPD and increase number of pieces of gum

• Abstinent 24 hours use gum as FDA recom

• Shiffman et al. Am J Prev Med 2009

P Tonnesen.2009

Reduction to quit with NRT OTC

• Results: Odds ratio for quitting vs. placebo

• 1 Month 6 Months

• 2-mg gum 2.01 1.80

• 4-mg gum 4.66 5.90

• Reducers more likely to quit

• Shiffman et al. 2009

P Tonnesen.2009

• A review of 11 studies of NRT used for smoking reduction found no unexpected adverse events, while side effects that may possibly be related to nicotine overdose (such as nausea and vomiting) were evenly distributed between active and placebo treatment groups (Fagerström & Hughes 2002)

• No increase in cardiovascular events (Murray et al 1996) in concurrent use of NRT and smoking for up to five years

Adverse events

P Tonnesen.2009

Use of nicotine 4 mg gum and smoking every hour (in order to attain unusually high plasma nicotine levels) revealed no evidence of adverse cardiac effects, even during exercise tests (Stahl et al 2001).

•The total nicotine intake remains broadly stable when smokers use NRT to reduce their cigarette smoking (Benowitz et al 1998)

Adverse events cont

P Tonnesen.2009

Conclusion : Smoking reduction

• Reduction possible long-term

• Reduction leads to cessation

• NRT increase ”success rates”

• Motivation to quit not decreased, but actually increased (55-80%)

• Recruitment of new segment of smokers

• Effect on health ? (if < 6 cig/day ?)

P Tonnesen.2009

NRT and smoking reduction

1. Fast acting NRT:

gum or inhaler,

sublingual, loozenge

(nasal spray) (mouth spray)

2. Use for 2-3 months: If reduced to less than 50 % then continue with NRT

P Tonnesen.2009

Treatment of most smokers is possible

Motivated to quit Motivated to reduce

SmokingReduction

Smokingcessation

Agressive smoking cessation with NRT: Combinations of 2 NRT’s;

bupropionSR; varenicline;

Recycling

NRT for 3-(18) months