Be careful what you use for smoking cessation.
http://www.docguide.com/fda-use-varenicline-associated-higher-risk-cardiovascular-events
A higher occurrence of major adverse cardiovascular events (a
combined outcome of cardiovascular-related death, nonfatal myocardial
infarction [MI], and nonfatal stroke) was observed in patients using
varenicline (Chantix) to aid in smoking cessation, compared with
placebo, according to a meta-analysis conducted by the US Food and Drug
Administration (FDA).
The FDA required the manufacturer of varenicline to conduct the
meta-analysis to further evaluate the cardiovascular safety of the drug,
and believes it is important to let healthcare professionals and
patients know about the results of this study.
Cardiovascular events were uncommon in both the varenicline and
placebo groups, and the increased risk was not statistically
significant, which means it is uncertain whether the excess risk for the
varenicline group was due to the drug or due to chance.
However, the data were analysed many different ways and consistently
showed a higher occurrence of events in patients using varenicline,
which makes it seem more likely that it is related to the drug and not
purely a chance finding.
Healthcare professionals are advised to weigh the risks of
varenicline against the benefits of its use. It is important to note
that smoking is a major risk factor for cardiovascular disease, and
varenicline is effective in helping patients to quit smoking and abstain
from it for as long as 1 year. The health benefits of quitting smoking
are immediate and substantial.
Patients taking varenicline should contact their healthcare
professional if they experience new or worsening symptoms of
cardiovascular disease, such as chest pain, shortness of breath, calf
pain when walking, or sudden onset of weakness, numbness, or difficulty
speaking.
Data Summary
The meta-analysis incorporated data from 7,002 patients (4,190 Chantix
and 2,812 placebo) that were enrolled in 15 Pfizer-sponsored,
randomised, double-blind, placebo-controlled clinical trials lasting ≥12
weeks.
The primary cardiovascular safety assessment included an analysis of
the occurrence and timing of major adverse cardiovascular events (MACE).
The MACE composite outcome included the following endpoints:
cardiovascular-related death, nonfatal MI, and nonfatal stroke.
Cardiovascular events included in this composite outcome were
adjudicated by a blinded, independent committee.
Overall, there was a low incidence of MACE occurring within 30 days
of treatment discontinuation (0.31% for varenicline vs 0.21% for
placebo). Exposure to varenicline resulted in an adjusted hazard ratio
of MACE of 1.95, which is based on trials reporting at least 1 MACE.
This is similar to an estimated increase of 6.3 MACE per 1,000
patient-years of exposure.
The meta-analysis also showed higher rates of composite outcomes in
patients on varenicline relative to placebo across different time frames
and pre-specified sensitivity analyses, including various study
groupings, and cardiovascular endpoints. Although these findings were
not statistically significant, they were consistent. Because the number
of adverse cardiovascular events was small overall, the power for
finding a statistically significant difference in a signal of this
magnitude is low.
It should be noted that the incidence of cardiovascular mortality
(0.05% for varenicline vs 0.07% for placebo) and all-cause mortality
(0.14% for varenicline vs 0.25% for placebo) was lower in the
varenicline group compared with the placebo group, although this finding
was also not statistically significant.
Adverse events should be reported to the FDA:
1-800-332-1088
1-800-FDA-0178 Fax
Mail to: MedWatch 5600 Fishers Lane
Rockville, MD 20857
SOURCE: US Food and Drug Administration
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