Chantix/Champix results from the largest global clinical trial of smoking cessation medicines published in The Lancet
Authors conclude no significant increase in serious neuropsychiatric adverse events with Chantix/Champix relative to placebo or nicotine patch.
Pfizer has announced results published in The Lancet from the largest clinical trial of approved smoking cessation medicines, called EAGLES (Evaluating Adverse Events in a Global Smoking Cessation Study). This smoking cessation trial included 8,144 adult smokers and was designed to compare the neuropsychiatric safety of Chantix/Champix (varenicline) and bupropion with placebo and nicotine patch in adult smokers with and without a history of psychiatric disorders. The authors concluded that the trial did not show a significant increase in the incidence of the composite primary safety endpoint of serious neuropsychiatric adverse events with Chantix/Champix or bupropion compared to placebo and nicotine patch. Differences between incidence rates were considered significant if their associated 95% confidence intervals (CIs) were entirely above or below zero. Approximately half of the trial participants had a history of psychiatric disorders, either past and in remission or present and clinically stable. The psychiatric diagnoses included primarily depressive, bipolar, anxiety and psychotic disorders.
The EAGLES trial also included an efficacy objective to determine smoking abstinence rates in patients treated with Chantix/Champix or bupropion, relative to placebo, during the last four weeks of the 12-week treatment period. Continuous abstinence was also evaluated relative to the nicotine patch. In addition, longer-term abstinence through a 12-week non-treatment follow-up period (weeks 9-24) was evaluated for all treatments. The results showed that patients with and without a history of psychiatric disorders taking Chantix/Champix had significantly higher continuous abstinence rates than patients treated with bupropion or nicotine patch during both time periods. Patients treated with each of the medications had higher abstinence rates than those treated with placebo. This is the first placebo-controlled trial of this size to directly compare the efficacy of Chantix/Champix, bupropion and nicotine patch to help people quit smoking.
“Clinical practice guidelines recommend that the most effective way for smokers to quit is by combining a smoking cessation medication with counselling. However, smoking cessation support is often underutilized, due in part to misperceptions about the effectiveness and safety of smoking cessation medicines,” said lead study investigator Robert M. Anthenelli, Professor of Psychiatry, University of California, San Diego, California. “This study offers important new information to prescribers and smokers to help them make an informed decision about smoking cessation treatment options.”
The primary safety endpoint of the EAGLES trial was defined as the occurrence of at least one treatment-emergent severe adverse event of anxiety, depression, feeling abnormal, or hostility and/or the occurrence of at least one treatment-emergent moderate or severe adverse event of agitation, aggression, delusions, hallucinations, homicidal ideation, mania, panic, paranoia, psychosis, suicidal ideation, suicidal behaviour or completed suicide.
Across the trial population, the most frequent adverse event by treatment group was nausea (25%, Chantix/Champix), insomnia (12%, bupropion), abnormal dreams (12%, nicotine patch) and headache (10%, placebo).
“Smoking is one of the leading preventable causes of death worldwide, and the benefits of quitting are immediate and substantial,” said Freda Lewis-Hall, Chief Medical Officer and EVP, 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.”
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