Authors conclude no significant increase in
serious neuropsychiatric adverse events with CHANTIX/CHAMPIX
relative to placebo or nicotine patch
Smokers treated with CHANTIX/CHAMPIX had
significantly higher quit rates than those treated with bupropion,
nicotine patch or placebo
Pfizer Inc. (NYSE:PFE) today 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.1
“Clinical practice guidelines recommend that the most effective
way for smokers to quit is by combining a smoking cessation
medication with counseling.2 However, smoking cessation support is
often underutilized, due in part to misperceptions about the
effectiveness and safety of smoking cessation medicines,”3 said
lead study investigator Robert M. Anthenelli, M.D., 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 behavior or completed
suicide.
The incidence of the primary safety endpoint in patients without
a history of psychiatric disorders was 1.3% (CHANTIX/CHAMPIX), 2.2%
(bupropion), 2.5% (nicotine patch) and 2.4% (placebo). The
incidence rates in patients with a history of psychiatric disorders
were 6.5% (CHANTIX/CHAMPIX), 6.7% (bupropion), 5.2% (nicotine
patch) and 4.9% (placebo). In patients without a history of
psychiatric disorders, the CHANTIX/CHAMPIX–placebo and
bupropion–placebo risk differences (RDs) for the primary safety
endpoint were −1.28 (95% CI −2.40 to −0.15) and −0.08 (−1.37 to
1.21), respectively. The RDs for CHANTIX/CHAMPIX-nicotine patch and
bupropion-nicotine patch comparisons were −1.07 (−2.21 to 0.08) and
0.13 (−1.19 to 1.45), respectively. In patients with a history of
psychiatric disorders, the CHANTIX/CHAMPIX–placebo and
bupropion–placebo RDs were 1.59 (−0.42 to 3.59) and 1.78 (−0.24 to
3.81), respectively; the RDs for CHANTIX/CHAMPIX-nicotine patch and
bupropion-nicotine patch comparisons were 1.22 (−0.81 to 3.25) and
1.42 (−0.63 to 3.46), respectively. Across both patient cohorts,
95% CIs associated with these RDs were lower than or included zero.
There were more neuropsychiatric adverse events in the psychiatric
cohort than the non-psychiatric cohort across all treatment arms
including placebo.4
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).4
“Smoking is one of the leading preventable causes of death
worldwide,5 and the benefits of quitting are immediate and
substantial,”6 said Freda Lewis-Hall, M.D., DFAPA, 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.”
The CHANTIX/CHAMPIX labeling includes a warning/boxed warning
regarding serious neuropsychiatric adverse events that have been
reported in some patients attempting to quit smoking while taking
CHANTIX/CHAMPIX in the post-marketing experience. Some people have
had changes in behavior, hostility, agitation, depressed mood, and
suicidal thoughts or actions while using CHANTIX/CHAMPIX to help
them quit smoking. If the CHANTIX/CHAMPIX patient, their family or
caregiver notices any of these symptoms or behaviors, they should
stop taking CHANTIX/CHAMPIX and call their doctor right away. They
should tell their doctor about any history of depression or other
mental health problems, which could get worse while taking
CHANTIX/CHAMPIX.
About EAGLES
EAGLES is a multi-center, parallel-group, post-authorization
safety study/post-marketing requirement (PASS/PMR), which was
conducted in 16 countries by Pfizer in collaboration with
GlaxoSmithKline. The trial was conducted at the request of, and
designed in consultation with, the U.S. Food and Drug
Administration (FDA) and the European Medicines Agency (EMA) to
compare the risk of clinically significant neuropsychiatric events,
including but not limited to suicidality, in individuals using
CHANTIX/CHAMPIX, bupropion, nicotine replacement therapy or placebo
as aids to smoking cessation over 12 weeks of treatment, and to
determine whether individuals with a history of psychiatric
disorders are at greater risk for developing clinically significant
neuropsychiatric events compared to individuals without a history
of psychiatric disorders while using CHANTIX/CHAMPIX or bupropion
as an aid to smoking cessation. Data limitations included: the
findings may not generalize to smokers with untreated or unstable
psychiatric disease, and the trial had limited power to detect rare
neuropsychiatric events.
About CHANTIX®
CHANTIX® (also known as CHAMPIX® in the EU and other countries)
was approved by the FDA in May 2006 as a prescription medication
that, along with support, helps adults 18 and over stop smoking.
Adults who smoke may benefit from quit- smoking support programs
and/or counseling during their quit attempt. It’s possible that
patients might slip up and smoke while taking CHANTIX/CHAMPIX. If
patients slip up, they can stay on CHANTIX/CHAMPIX and keep trying
to quit.
Important CHANTIX (varenicline) Safety Information
Some people have had changes in behavior, hostility,
agitation, depressed mood, suicidal thoughts or actions while using
CHANTIX to help them quit smoking. Some people had these symptoms
when they began taking CHANTIX, and others developed them after
several weeks of treatment or after stopping CHANTIX. If the
CHANTIX patient, their family or caregiver notice any of these
symptoms or behaviors, they should stop taking CHANTIX and call
their doctor right away. They should tell their doctor about any
history of depression or other mental health problems, which could
get worse while taking CHANTIX.
Some people had seizures during treatment with CHANTIX. Most
cases happened during the first month of treatment. Patients should
tell their doctor if they have a history of seizures. If a patient
has a seizure during treatment with CHANTIX, he/she should stop
taking CHANTIX and contact his/her healthcare provider right
away.
Patients should decrease the amount of alcohol they drink while
taking CHANTIX until they know if CHANTIX affects their ability to
tolerate alcohol. Some people experienced increased drunkenness,
unusual or sometimes aggressive behavior, or memory loss of events
while consuming alcohol during treatment with CHANTIX.
Patients should not take CHANTIX if they’ve had a serious
allergic or skin reaction to it. If they develop serious allergic
or skin reactions, including swelling of the face, mouth, throat,
or a rash, they should stop taking CHANTIX and see their doctor
right away as some of these can be life-threatening.
Patients should tell their doctor if they have a history of
heart or blood vessel problems or have any new or worse symptoms
during treatment with CHANTIX. Patients should get emergency
medical help right away if they have any symptoms of a heart attack
or stroke.
Dosing may be different for patients who have kidney problems.
Until the patient knows how CHANTIX affects them, they should use
caution when driving or operation machinery. Common side effects
include nausea, trouble sleeping and unusual dreams. CHANTIX should
not be taken with other quit-smoking products. Patients should tell
their doctor which medicines they are taking as these medicines may
work differently when quitting smoking.
Click here for full Prescribing Information, including BOXED
WARNING and Medication Guide.
About Pfizer Inc.: Working together for a healthier
world®
At Pfizer, we apply science and our global resources to bring
therapies to people that extend and significantly improve their
lives. We strive to set the standard for quality, safety and value
in the discovery, development and manufacture of health care
products. Our global portfolio includes medicines and vaccines as
well as many of the world's best-known consumer health care
products. Every day, Pfizer colleagues work across developed and
emerging markets to advance wellness, prevention, treatments and
cures that challenge the most feared diseases of our time.
Consistent with our responsibility as one of the world's premier
innovative biopharmaceutical companies, we collaborate with health
care providers, governments and local communities to support and
expand access to reliable, affordable health care around the world.
For more than 150 years, Pfizer has worked to make a difference for
all who rely on us. For more information, please visit us
at www.pfizer.com. In addition, to learn more, follow us on
Twitter at @Pfizer
and @Pfizer_News, LinkedIn, YouTube and like us
on Facebook at Facebook.com/Pfizer.
DISCLOSURE NOTICE: The information contained in this release is
as of April 22, 2016. Pfizer assumes no obligation to update
forward-looking statements contained in this release as the result
of new information or future events or developments.
This release contains forward-looking information regarding
CHANTIX/CHAMPIX, including its potential benefits, that involves
substantial risks and uncertainties that could cause actual results
to differ materially from those expressed or implied by such
statements. Risks and uncertainties include, among other things,
uncertainties regarding the commercial impact of the results of the
EAGLES study; uncertainties regarding the impact of the EAGLES
study on the product labeling for CHANTIX/CHAMPIX in the United
States or other jurisdictions; the risk that clinical trial data
are subject to differing interpretations, including by regulatory
authorities; the uncertainties inherent in research and
development; and competitive developments.
A further description of risks and uncertainties can be found in
Pfizer’s Annual Report on Form 10-K for the fiscal year ended
December 31, 2015 and in its subsequent reports on Form 10-Q,
including in the sections thereof captioned “Risk Factors” and
“Forward-Looking Information and Factors That May Affect Future
Results,” as well as in its subsequent reports on Form 8-K, all of
which are filed with the U.S. Securities and Exchange Commission
and available at www.sec.gov and www.pfizer.com.
References:1 Cahill K, Stevens S, Perera R, Lancaster T.
Pharmacological interventions for smoking cessation: an overview
and network meta-analysis. Cochrane Database Syst Rev 2013; 5:
CD009329. doi: 10.1002/14651858.2 Fiore MC, Jaeìn CR, Baker TB, et
al. Treating Tobacco Use and Dependence: 2008 Update. Clinical
Practice Guideline. Rockville, MD: U.S. Department of Health and
Human Services. Public Health Service. May 2008.3 Smith AL, Carter
SM, Chapman S, Dunlop SM, Freeman B. Why do smokers try to
quit without medication or counselling? A qualitative study with
ex-smokers. BMJ Open 2015;5:e007301.
doi:10.1136/bmjopen-2014-007301.4 Anthenelli RM, Benowitz NL, West
R, et al. Neuropsychiatric safety and efficacy of varenicline,
bupropion, and nicotine patch in smokers with and without
psychiatric disorders (EAGLES): a double-blind, randomised,
placebo-controlled clinical trial. Lancet. 2016 Apr 19:e1-e14.[Epub
ahead of print].5 Centers for Disease Control and Prevention (CDC).
Smoking & Tobacco Use Fast Facts.
http://www.cdc.gov/tobacco/data_statistics/fact_sheets/fast_facts/index.htm#toll.
Accessed April 1, 2016.6 Centers for Disease Control and Prevention
(CDC). The Surgeon General’s 1990 Report on the Health Benefits of
Smoking Cessation Executive Summary – Preface. MMWR. 1990,
39(RR-12), 8-15.
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Pfizer Inc.Media:Steven Danehy,
212-733-1538Steven.Danehy@pfizer.comorInvestors:Ryan Crowe,
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