1. Changes to the UK licence for NRT: rationale
Robert West
University College London
WCTOH July 2006 Washington

2. Outline Review of licensing changes and their rationale Extended use
Concurrent use of different forms of NRT
Use by cardiac patients
Use by pregnant smokers
Use by young smokers
‘Cut Down Then Stop’

3. Extended use
Evidence from clinical trials has not supported the effectiveness of extending use of nicotine patch beyond 8 weeks but …
a substantial minority of users of gum and other products feel vulnerable to relapse after 8-12 weeks
there is evidence for an increase in relapse rate on termination of use
there are no major safety concerns about extended use

4. Concurrent use
Evidence from clinical trials indicates that combinations are more effective on average than single forms but …
the evidence is not completely conclusive
it is not clear whether some combinations are better than others or than specific individual forms of NRT
there are no significant safety concerns

5. Use by cardiac patients
NRT has not been shown specifically to be effective in this patient group and the pharmacology of nicotine suggests a theoretical risk but …
there is a reasonable presumption of efficacy given data from healthy smokers
it appears to have been safe to use in cardiac patients
the imperative to stop smoking in this group is high

6. Use by pregnant smokers
NRT has not been shown to be specifically effective in this group and nicotine has been shown to be teratogenic but …
there is a reasonable presumption of efficacy given data from healthy smokers
there is a reasonable presumption that NRT is much safer than smoking
the imperative to stop smoking in this group is high

7. Use by young smokers
NRT has not been shown to be specifically effective in this group but …
there is a presumption that it may have some effect in young smokers that are clearly nicotine dependent
there are no major safety concerns

8. Cut Down Then Stop
Clinical trials have shown that gum or inhalator use in smokers wanting to stop but who do not feel ready or able to make a quit attempt in the near future results in approximately 4% more of them stopping smoking within the next 12 months but …
it is not clear what the effect this will have when rolled out to the smoking population as a whole

9. Conclusions
Extending the indications and usage of NRT is likely to have a net public health benefit and to prevent death and disability in the case of individual smokers
It is important to monitor the effect of the changes in the population to ensure that the benefit and cost-benefit are maximised and to allay possible safety concerns in some cases
reduction/NRT pdf