Effect of Varenicline on Smoking Cessation Through Smoking Reduction

Kristi Tinsbloom, Mercer University College of Pharmacy 2015

It is estimated that smoking-related diseases account for 443,000 deaths each year in the United States. There are numerous diseases and conditions that can be caused by smoking including chronic obstructive pulmonary disease (COPD), stroke, coronary heart disease, peptic ulcer disease, and various forms of cancer. Cigarette smoking is considered to be the largest source of preventable morbidity and mortality among people worldwide.1

A recently published study investigates the benefit to a smoking cessation program that incorporates an element of smoking reduction for patients who are not comfortable with abrupt smoking discontinuation. According to the authors of the study, smokers approaching cessation in this gradual way may see better long-term results.2

Primary Outcome Measure: Carbon monoxide-confirmed (exhaled level of less than or equal to 10 ppm) self-reported continuous abstinence rate (CAR) during weeks 15 through 24

Title: Effect of Varenicline on Smoking Cessation Through Smoking Reduction2
Design Randomized, double-blind, placebo-controlled; 1510 participants
Objective To determine the efficacy and safety of varenicline for increasing smoking abstinence rates through smoking reduction
Study groups Two groups:
• Varenicline titrated to 1 mg twice daily
• Placebo
*Smoking reduction target for both groups of greater than or equal to 50% in number of cigarettes smoked by week 4, greater than or equal to 75% by week 8, and a quit attempt by week 12
Methods 24-week treatment period followed by 28-week non-treatment follow-up phase; the first 12 weeks of treatment was the reduction phase and the next 12 weeks was the abstinence phase
Duration July 2011 to July 2013
Baseline Characteristics Varenicline group
Mean age (yrs) 44.7
Age started smoking (yrs) 17.3
No. of cigarettes per day in past month 20.6
Longest period of abstinence in past year (days) 4
No. of patients with no previous quit attempts 130 (17.1%)Placebo group
Mean age (yrs) 44.4
Age started smoking (yrs) 17.3
No. of cigarettes per day in past month 20.8
Longest period of abstinence in past year (days) 3
No. of patients with no previous quit attempts 159 (21.2%)
Results The continuous abstinence rate during weeks 15 through 24 were 32.1% and 6.9% in the varenicline and placebo groups, respectively (RD = 25.2% [95% CI, 21.4%-29.0%]). The median time from baseline to the beginning of the continuous abstinence period was 50 days for the varenicline group and 85 days for the placebo group.
Adverse Events Common Adverse Events: nausea (27.8%), nasopharyngitis (13.0%), abnormal dreams (11.5%), insomnia (10.7%)
Serious Adverse Events: suicidal ideation or behavior (0.8%)
Percentage that Discontinued due to Adverse Evens: 7.7%
Study Author Conclusions The use of varenicline for 24 weeks increased smoking cessation rates compared to placebo in cigarette smokers who were not willing or able to quit within the next month, but were willing to reduce cigarette use and make an attempt to quit in 3 months. Varenicline is a viable option for treatment for smokers whose needs are not addressed by current guidelines suggesting abrupt smoking cessation.

This study using varenicline as a treatment option for patients who are not ready for abrupt cessation could impact the future of smoking cessation guidelines. The continuous abstinence rates of the study group through the follow-up period indicate the usefulness of varenicline as supplementation to reduction. Varenicline use to augment smoking reduction can certainly lead to decreased diagnosed health problems as well as health care cost savings.

References
1. American Lung Association. http://www.lung.org/stop-smoking/about-smoking/facts-figures/general-smoking-facts.html. Accessed February 18, 2015.

2. Ebbert JO, Hughes JR, West RJ, et al. Effect of Varenicline on Smoking Cessation Through Smoking Reduction: A Randomized Clinical Trial. JAMA. 2015;313(7):687-694.

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