Smokers taking Chantix/Champix have a higher quit rate and a decrease in neuropsychiatric adverse effects.
Pfizer Inc recently announced promising results from a 12-week clinical trial called EAGLES for a smoking cessation treatment. Researchers found that smokers treated with Chantix/Champix had higher quit rates than patients treated with bupropion, nicotine patch, or placebo.
The study, published in The Lancet, included 8144 adult smokers with and without a history of psychiatric disorders and compared the neuropsychiatric safety of Chantix/Champix or bupropion compared with placebo and nicotine patch.
Approximately half of the patients had a history of psychiatric disorders, primarily depressive, bipolar, anxiety, and psychotic disorders.
The trial included an efficacy objective in order to determine smoking abstinence rates in patients treated with Chantix/Champix or bupropion compared with the placebo group and nicotine patch group during the last 4 weeks of the treatment.
Smoking abstinence through a 12-week non-treatment follow-up period was evaluated in all groups.
Researchers found that patients taking Chantix/Champix had higher continuous abstinence rates than patients treated with either bupropion or nicotine patch during both observed periods.
Patients treated with either medication also had higher abstinence rates than patients treated with placebo.
“Clinical practice guidelines recommend that the most effective way for smokers to quit is by combining a smoking cessation medication with counseling. However, smoking cessation support is often underutilized, due in part to misperceptions about the effectiveness and safety of smoking cessation medicines,” said study lead researcher Robert M. Anthenelli, MD. “This study offers important new information to prescribers and smokers to help them make an informed decision about smoking cessation treatment options.”
This trial also studied the effects of the drug and neuropsychiatric adverse effects on patients with and without a history of psychiatric disorders.
According to the study, the primary safety endpoint was the occurrence of at least 1 treatment-emergent severe adverse event of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least 1 treatment-emergent moderate or severe adverse event of agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behavior, or completed suicide.
The incidence rates of the primary safety endpoint in patients without a history of psychiatric disorders were 1.3% with Chantix/Champix, 2.2% with bupropion, 2.5% with a nicotine patch, and 2.4% with placebo.
The incidence rates of the primary safety endpoint in patients with a history of psychiatric disorders were 6.5% with Chantix/Champix, 6.7% with bupropion, 5.2% with nicotine patch, and 4.9% with placebo.
Of the patients taking Chatinx/Champix, 25% experienced nausea.
“Smoking is one of the leading preventable causes of death worldwide, and the benefits of quitting are immediate and substantial,” concluded Freda Lewis-Hall, MD, DFAPA, chief medical officer and executive vice president for Pfizer Inc. “These data from the EAGLES study build on the large body of clinical evidence characterizing the neuropsychiatric safety and efficacy of Chantix/Champix, which supports Chantix/Champix as an important treatment option for people who want to quit smoking."