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Varenicline Efficacy in CVD Smokers

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13 views1 page

Varenicline Efficacy in CVD Smokers

Uploaded by

runfastlivefast
Copyright
© All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd

Abstract

Background— Smoking cessation is a key component of secondary cardiovascular


disease prevention. Varenicline, a partial α4β2 nicotinic acetylcholine receptor
agonist, is effective for smoking cessation in healthy smokers, but its efficacy and
safety in smokers with cardiovascular disease are unknown.
Methods and Results— A multicenter, randomized, double-blind, placebo-controlled
trial compared the efficacy and safety of varenicline with placebo for smoking
cessation in 714 smokers with stable cardiovascular disease. Participants received
varenicline (1 mg twice daily) or placebo, along with smoking-cessation counseling,
for 12 weeks. Follow-up lasted 52 weeks. The primary end point was carbon
monoxide-confirmed continuous abstinence rate for weeks 9 through 12 (last 4
weeks of treatment). The continuous abstinence rate was higher for varenicline than
placebo during weeks 9 through 12 (47.0% versus 13.9%; odds ratio, 6.11; 95%
confidence interval [CI], 4.18 to 8.93) and weeks 9 through 52 (19.2% versus 7.2%;
odds ratio, 3.14; 95% CI, 1.93 to 5.11). The varenicline and placebo groups did not
differ significantly in cardiovascular mortality (0.3% versus 0.6%; difference, −0.3%;
95% CI, −1.3 to 0.7), all-cause mortality (0.6% versus 1.4%; difference, −0.8%; 95%
CI, −2.3 to 0.6), cardiovascular events (7.1% versus 5.7%; difference, 1.4%; 95% CI,
−2.3 to 5.0), or serious adverse events (6.5% and 6.0%; difference, 0.5%; 95% CI,
−3.1 to 4.1). As a result of adverse events, 9.6% of varenicline and 4.3% of placebo
participants discontinued study drug.
Conclusions— Varenicline is effective for smoking cessation in smokers with
cardiovascular disease. It was well tolerated and did not increase cardiovascular
events or mortality; however, trial size and duration limit definitive conclusions
about safety.
Clinical Trial Registration Information— URL:
[Link] Unique identifier:
NCT00282984.
Cigarette smoking is a major risk factor for cardiovascular disease (CVD).1 Among
smokers with coronary heart disease, smoking cessation is associated with a 36%
reduction in risk of all-cause mortality,2 making smoking cessation fundamental to
secondary prevention of CVD.3 Although an acute myocardial infarction (MI) or
other hospitalization for CVD motivates many smokers to quit in the short term,
most resume smoking.4 The result is a large number of smokers with stable CVD
who need to quit. Identifying more effective tobacco-dependence treatment for
patients with CVD is a high priority for CVD prevention.5
Editorial see p 188
Clinical Perspective on p 229

Common questions

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The study indicates that varenicline maintains higher abstinence rates beyond the active treatment phase, with a continuous abstinence rate at weeks 9-52 of 19.2% compared to 7.2% for placebo, suggesting sustained efficacy in supporting smoking cessation .

Varenicline, as a partial α4β2 nicotinic acetylcholine receptor agonist, is effective in aiding smoking cessation by simulating the effects of nicotine on the brain to reduce withdrawal symptoms and cravings. The study showed varenicline had significantly higher continuous abstinence rates compared to placebo in weeks 9-12 (47.0% versus 13.9%; odds ratio, 6.11) and weeks 9-52 (19.2% versus 7.2%; odds ratio, 3.14).

The study employed a multicenter, randomized, double-blind, placebo-controlled trial design. Participants received varenicline or placebo along with smoking-cessation counseling for 12 weeks, with follow-up lasting 52 weeks. The primary endpoint was carbon monoxide-confirmed continuous abstinence rate, ensuring a rigorous and objective assessment of smoking cessation .

Smoking cessation in patients with stable cardiovascular disease is crucial as it is associated with a 36% reduction in all-cause mortality risk. Despite motivation from acute cardiovascular events, many resume smoking, thus emphasizing the need for effective cessation treatments to enhance CVD prevention outcomes .

The trial's size and duration are crucial as they limit the statistical power to detect rare events or long-term adverse effects, which means that while results suggest varenicline is safe, these limitations prevent drawing definitive conclusions about its safety over extended periods in patients with cardiovascular conditions .

The study found no significant difference between varenicline and placebo groups in cardiovascular mortality (0.3% versus 0.6%) and all-cause mortality (0.6% versus 1.4%), indicating that varenicline did not increase mortality risk among participants .

Serious adverse events were similar between varenicline (6.5%) and placebo (6.0%) groups, while trial discontinuation due to adverse effects was higher in the varenicline group (9.6% versus 4.3%), indicating a higher tolerance challenge with varenicline .

Clinicians should consider varenicline as an effective option for smoking cessation in cardiovascular patients, given its superior abstinence rates. However, they must weigh the risks of adverse events and patient tolerance, continuously monitoring those on varenicline and considering its long-term safety cautiously due to the study's limitations .

The study suggests that varenicline is efficacious in smoking cessation, with higher abstinence rates compared to placebo. However, the safety aspect, while showing no significant increase in cardiovascular or all-cause mortality, indicates some risk due to adverse effects leading to discontinuation. The trial's limited size and duration caution against definitive conclusions about long-term safety in this demographic .

The high prevalence of smoking relapse among patients with cardiovascular disease, despite initial cessation following cardiovascular events, underscores the need for effective interventions. This suggests a gap in current cessation strategies that new treatments like varenicline aim to fill, highlighting the ongoing challenge of maintaining long-term behavioral change in this population .

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