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Varenicline Safe for Smoking Cessation in Schizophrenia?


June 14, 2012 — Varenicline (Chantix, Pfizer) is a safe and effective aid to help patients with stably treated schizophrenia or schizoaffective disorder to stop smoking, new research suggests.
Results of a randomized trial showed that 12 weeks of treatment of patients with these disorders was more effective at achieving smoking cessation than placebo, with no increase in adverse events, including suicidal ideation and suicidal attempts.
"Smokers with psychotic disorders are motivated to try to quit smoking and should routinely be provided with smoking cessation treatment," lead author Jill M. Williams, MD, director of the Division of Addiction Psychiatry at the University of Medicine and Dentistry of New Jersey–Robert Wood Johnson Medical School, in New Brunswick, told Medscape Medical News.
Dr. Jill Williams
"In addition, pharmacotherapy should be used more aggressively to help these smokers to quit," she added. "Placebo quit rates in smokers with schizophrenia and schizoaffective disorder are lower than in other smokers, suggesting that behavioral approaches alone will be ineffective in these smokers, who are typically highly nicotine dependent."
Tony George, MD, clinical director of the Schizophrenia Program at the Centre for Addiction and Mental Health, University of Toronto, in Canada, and who is a coauthor of the study, told Medscape Medical News that the results should be considered reassuring.
"The study is important, insofar as providing some reassurance that varenicline can be used safely and effectively in this difficult subset of smokers with schizophrenia and schizoaffective disorder, especially as tobacco-related illness may be the leading cause of death and disability in these patients."
Their findings are published in the May issue of the Journal of Clinical Psychiatry. The study was funded by Pfizer, manufacturer of varenicline.
Higher Smoking Prevalence
The prevalence of smoking in individuals with schizophrenia or schizoaffective disorder is higher than in the general population, at about 80% vs about 21%. This patient population also exhibits greater nicotine intake per cigarette and greater severity of nicotine dependence, and so may require a more potent treatment plan.
"However, these treatments to help patients stop smoking must be safe and not interact with other medications used in the treatment of schizophrenia," Dr. George said.
Recently, though, a large study of more than 13,000 participants published in the November 2011 issue of PLoS One and reported by Medscape Medical News suggested that the drug is associated with a significantly increased risk for depression and suicide.
At that time, the study's coinvestigator Curt D. Furberg, MD, professor of public health sciences at Wake Forest Baptist Medical Center in Winston-Salem, North Carolina, told Medscape Medical News that varenicline should "not be used as a first-line drug."
In the current study, Dr. Williams and her team randomly assigned 127 patients in a 2:1 ratio who smoked at least 15 cigarettes per day and who had a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition,confirmed diagnosis of schizophrenia or schizoaffective disorder to receive varenicline (n = 84 patients) or placebo (n = 43) for 12 weeks.
Varenicline dosing began with a 1-week titration period, during which patients took 1 .5-mg oral tablet each evening on days 1 to 3 of the first week, followed by 2 .5-mg tablets per day, taken in the morning and evening for the next 4 days.
From week 2 to week 12, patients took 2 1-mg tablets in the morning and evening.
At the end of 12 weeks of treatment, varenicline-treated patients had a significantly higher abstinence rate from smoking, as verified by a carbon monoxide measure of 10 ppm or less, with 16 of 84 patients (19%) being abstinent from smoking compared with 2 of 43 patients (4.7%) in the placebo group being abstinent (P = .046).
At 24 weeks, the varenicline-treated patients continued to show a trend of reduced cigarette use, with 10 of 84 (11.9%) of varenicline-treated patients and 1 of 43 (2.3%) of placebo-treated patients showing evidence of abstinence (P = .90).
Varenicline was safe, and total adverse events were similar between the 2 groups. There were no significant changes in symptoms of schizophrenia or in mood and anxiety ratings.
Rates of suicidal ideation were similar in both groups (6% with varenicline and 7% with placebo; P = 1.0). One patient on varenicline attempted suicide, but that patient had a lifetime history of similar attempts, with no completed suicides, Dr. Williams noted.
Not Convinced
Sonal Singh, MD, MPH, assistant professor at Johns Hopkins University, in Baltimore, Maryland, told Medscape Medical News that the data in this study did not convince him that varenicline was safe in this patient population.
Dr. Sonal Singh
"The overall power of the study was too small to detect a statistically significant difference in completed suicides with varenicline. Although there was no statistically significant difference between varenicline and comparators on suicidal ideation during the treatment phase, the study discussion shows that 6 patients had suicidal ideation during the posttreatment phase more than 30 days after varenicline," Dr. Singh said.
"Additionally, there was 1 attempted suicide in the varenicline arm. There was 1 accidental drowning in the varenicline arm. In none of these cases can one rule out the role of varenicline in causing these events. Because of these safety concerns, I am not reassured that varenicline is safe to use in patients with schizophrenia," he said.
The study was sponsored by Pfizer. Dr. Williams reports that she has received research support from the National Institutes of Health (NIH [National Institute of Mental Health and National Institute on Drug Abuse]) and Pfizer. Dr. George reports financial relationships with Pfizer, Sanofi-Aventis, Novartis, Eli Lilly, Prepharm, AstraZeneca, Janssen, and Sepracor, and that he has received grant support from the NIH, Canadian Institutes of Health Research, Canada Foundation for Innovation, and the Ontario Mental Health Foundation. Dr. Singh has disclosed no relevant financial relationships.

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