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DRUG, ALCOHOL, AND SUBSTANCE ABUSE

Safety and Effectiveness of Varenicline in a Veteran Population with a High Prevalence of Mental Illness

Psychiatric Pharmacy Practice Resident, Western Missouri Mental Health Center, Kansas City, MO

Scott E Mambourg, PharmD BCPS

Clinical Pharmacy Coordinator, Veterans Affairs Sierra Nevada Healthcare System, Reno, NV

Tracie M Balvanz, PharmD

Clinical Pharmacy Specialist, Veterans Affairs Sierra Nevada Healthcare System

Heather E Magallon, PharmD BCPS

Clinical Pharmacy Specialist, Veterans Affairs Sierra Nevada Healthcare System

Richard H Pham, PharmD

VISN 21 PBM Program Manager, Veterans Affairs Sierra Nevada Healthcare System

Reprints: Dr. Purvis, Department of Pharmacy, Western Missouri Mental Health Center, 1000 East 24th St., Kansas City, MO 64108, fax 816/512-7486, tara.purvis{at}dmh.mo.gov

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.

Key Words: Chantix, effectiveness, safety, smoking cessation, tobacco, varenicline

Published Online, April 21, 2009. www.theannals.com, DOI 10.1345/aph.1L661

This article has been cited by other articles:

				A. A Kreshak, A. K Clark, R. F Clark, B. T Ly, and F L. Cantrell A Retrospective Poison Center Review of Varenicline-Exposed Patients Ann. Pharmacother., December 1, 2009; 43(12): 1986 - 1991. [Abstract] [Full Text] [PDF]