[Tolerability profile of varenicline in current medical practice].
BACKGROUND
Varenicline (Champix) was approved in France in 2006 as an aid to smoking cessation treatment. Although there is a consensus on its efficacy, its tolerability is debatable. This article sought to clarify its tolerability profile in current medical practice.


METHODS
This retrospective study examined tolerance of varenicline prescribed to smokers who wanted to quit smoking in 10 "Stop-Smoking" consultation centers around France. It included all patients who used varenicline during the one-year (February 12, 2007, to February 12, 2008) study period.


RESULTS
At least one adverse event (AE) was reported by 45.9% of the 338 patients, with a total of 343. AE incidence was higher among women (51.5%) than men (40.5%) (OR=1.56, 95% CI: 0.99-2.47, p=0.026). There were 32 unexpected AEs, that is, not listed in the initial new drug application, reported by 23 patients, including 19 psychiatric AEs. Of the 8 serious AEs, 3 were of neurological origin.


CONCLUSIONS
This retrospective study confirmed the tolerability issues for varenicline, identified during the phase II-phase III development program and confirmed afterwards. It raises the following questions: Should varenicline be prescribed as a second-line therapy? Is there a patient type for which varenicline would be more - or less - appropriate? Can the tolerability profile be improved by reducing dosage while maintaining the level of efficacy or by co-administering symptomatic treatment more systematically? These are questions that new studies evaluating varenicline tolerability should answer.
Dupont
Patrick
P
Service d'Addictologie, Hôpital Paul Brousse, F-94800 Villejuif, France. patrick.dupont@pbr.aphp.fr
Gillet
Claudine
C
Guerin
Martine
M
Kalamarides
Sophie
S
Larinier
Elisabeth
E
Meignan
Claire
C
Moreau
Aline
A
Guillaumin
Claude
C
Perriot
Jean
J
D000328:Adult; D001552:Benzazepines / Q000009:adverse effects*; D005260:Female; D005602:France; D005767:Gastrointestinal Diseases / Q000139:chemically induced; D006801:Humans; D008297:Male; D001523:Mental Disorders / Q000139:chemically induced; D008659:Metabolic Diseases / Q000139:chemically induced; D009422:Nervous System Diseases / Q000139:chemically induced; D018722:Nicotinic Agonists / Q000009:adverse effects*; D011810:Quinoxalines / Q000009:adverse effects*; D012189:Retrospective Studies; D012871:Skin Diseases / Q000139:chemically induced; D012907:Smoking / Q000188:drug therapy*; D000068580:Varenicline
D001552:Benzazepines; D018722:Nicotinic Agonists; D011810:Quinoxalines; D000068580:Varenicline