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