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.

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.”