Changes to the UK licence for NRT: rationale

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 http://www.ash.org.uk/html/cessation/Smoking reduction/NRT051229.pdf