Safety and effectiveness of varenicline in a veteran population with a high prevalence of mental illness.
BACKGROUND
Varenicline is a selective nicotinic receptor partial agonist used to aid in the process of smoking cessation. Research on varenicline's approval for marketing demonstrated that after 12 weeks of treatment, at least 44% of patients successfully quit smoking and, on average, 13% of individuals discontinued therapy due to an adverse drug event (ADE). Growing postmarketing data linked varenicline to an increase in neuropsychiatric symptoms.


OBJECTIVE
To evaluate the safety profile, specifically psychiatric symptoms, and effectiveness of varenicline in a veteran population and to determine whether there is an association among specific baseline demographics and success rate.


METHODS
The study was a retrospective review of a prospective performance measure involving veterans initiated on varenicline. Patients were contacted via telephone throughout treatment and at week 12 for effectiveness follow-up. Smoking history was obtained and medication counseling was provided. The primary endpoint was tobacco cessation between weeks 9 and 12 of therapy. Varenicline's safety profile and discontinuation rates due to ADEs were also analyzed.


RESULTS
Of the 50 patients included in the study, 30% (n = 15) successfully quit smoking and 70% (n = 35) failed therapy (lack of effectiveness, n = 22; intolerability, n = 13). Prevalence of underlying mental illness in the success group (4/15; 27%) versus failure group (20/35; 57%) was statistically significant (p < 0.001). All patients who discontinued therapy due to an increase in mood and behavioral changes (n = 4) had an underlying psychiatric illness. The study results demonstrate a lower success rate and a higher incidence of discontinuation due to an ADE in our veteran population compared with premarketing data. An inverse association was shown between psychiatric disorders and success.


CONCLUSIONS
Cautious treatment initiation and close monitoring of veterans initiated on varenicline are warranted. Furthermore, the results from this study demonstrate the need for prospective effectiveness trials to determine the clinical significance of the results.
Purvis
Tara L
TL
Western Missouri Mental Health Center, Kansas City, MO 64108, USA. tara.purvis@dmh.mo.gov
Mambourg
Scott E
SE
Balvanz
Tracie M
TM
Magallon
Heather E
HE
Pham
Richard H
RH
D000328:Adult; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D001552:Benzazepines / Q000009:adverse effects* / Q000627:therapeutic use*; D017831:Diagnosis, Dual (Psychiatry); D005260:Female; D006801:Humans; D008297:Male; D001523:Mental Disorders / Q000139:chemically induced / Q000150:complications*; D008875:Middle Aged; D018722:Nicotinic Agonists / Q000009:adverse effects* / Q000627:therapeutic use*; D011810:Quinoxalines / Q000009:adverse effects* / Q000627:therapeutic use*; D012189:Retrospective Studies; D012737:Sex Factors; D016540:Smoking Cessation / Q000379:methods*; D014029:Tobacco Use Disorder / Q000150:complications* / Q000188:drug therapy*; D000068580:Varenicline; D014728:Veterans
D001552:Benzazepines; D018722:Nicotinic Agonists; D011810:Quinoxalines; D000068580:Varenicline