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CHAMPIX (varenicline), brain nicotinic receptor partial agonist

TRANSPARENCY COMMITTEE OPINION
Opinions on drugs - Posted on Jan 12 2017

Reason for request

Inclusion

Substantial clinical benefit in smoking cessation

 

  • CHAMPIX has Marketing Authorisation for smoking cessation in adults. 
  • Two studies versus placebo, one performed in subjects with chronic obstructive pulmonary disease (COPD) and the other in subjects with cardiovascular diseases, have demonstrated a small amount of effect of varenicline on short- and long-term smoking cessation.
  • A study evaluated the safety and efficacy of varenicline and bupropion versus nicotine replacement therapies (NRT) and placebo in smoking cessation in smokers with and without histories of psychiatric disorders. The continuous abstinence rate from weeks 9 to 12 was significantly higher in the varenicline group than in the placebo group and than in the NRT and bupropion groups. These results are consistent with the results of a Cochrane meta-analysis that confirms the effectiveness of varenicline.
  • The safety data did not highlight any increased risk of neuropsychiatric events from varenicline.
  • CHAMPIX is a second-line medicine in the treatment strategy reserved for highly dependent subjects.

 

 

 

 


Actual benefit

Important

-


Improvement in actual benefit

V (absence)

-


Therapeutic use

-

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