Effectiveness and safety of varenicline for smoking cessation: An overview and meta-analysis

Effectiveness and safety of varenicline for smoking cessation: An overview and meta-analysis

Published: September/October 2023

Journal Article

Overview

This 1-hour, journal article-based CME activity is based on an overview, meta-analysis, and trial sequential analysis were conducted to evaluate the efficacy and safety of varenicline for smoking cessation.

The target audience for this intermediate activity includes physicians, nurse practitioners, physician assistants, and other clinicians, researchers and academics, residents, fellows, students and counselors and policymakers.

This activity addresses the following ACGME Competencies: Patient Care and Procedural Skills, Medical Knowledge, Practice-Based Learning and Improvement, Interpersonal and Communication Skills, Professionalism, and Systems Based Practice.

Article Abstract

Objectives: An overview, meta-analysis, and trial sequential analysis were conducted to evaluate the efficacy and safety of varenicline for smoking cessation.

Methods: Systematic reviews (SRs) and randomized controlled trials evaluating varenicline versus placebo for smoking cessation were included. A forest plot was used to summarize the effect size of the included SRs. Traditional meta-analysis and trial sequential analysis (TSA) were performed using Stata software and TSA 0.9 software, respectively. Finally, the Grades of Recommendation, Assessment, Development, and Evaluation approach was used to assess the quality of evidence for the abstinence effect. 

Results: A total of 13 SRs and 46 randomized controlled trials were included. Twelve review studies showed that varenicline was superior to placebo for smoking cessation. The meta-analysis results showed that, compared with the placebo, varenicline significantly increased the odds of smoking cessation (odds ratio = 2.54, 95% confidence interval = 2.20-2.94, P < 0.05, moderate quality). Subgroup analysis showed that there were significant differences in smokers with disease and general smokers (P < 0.05). Differences were also found in the follow-up time at 12, 24, and 52 weeks (P < 0.05). The common adverse events were nausea, vomit, abnormal dreams, sleep disturbances, headache, depression, irritability, indigestion, and nasopharyngitis (P < 0.05). The TSA results confirmed the evidence for the effect of varenicline on smoking cessation. 

Conclusions: Existing evidence supports the superiority of varenicline over a placebo for smoking cessation. Varenicline had mild to moderate adverse events but was well tolerated. Future trials should investigate varenicline in combination with other smoking cessation approaches and compare it with other interventions.

Learning Objectives

Upon completion, learners will be able to:

1. Summarize the results of a systematic review of the research comparing varenicline to placebo to evaluate its efficacy and safety for smoking cessation. 
2. Discuss how results of this systematic review may be used to guide clinical smoking cessation practices and its implications for future research. 

Registration Rates

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Refunds & Cancellations

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Registration Deadline: 10/02/2026

User Access Closed Date: 11/03/2026

Course Instructions

1. Click on the Contents tab to begin this activity.
2. Click View Journal Article and read the journal article in its entirety. 
3. Click Complete Post Test to answer multiple choice questions. Participants will have 10 attempts to pass and must answer 2 out of 3 questions correctly.
4. Click Complete Evaluation to provide valuable activity feedback. Scroll down on all questions as there may be answer options that expand past the size of the window.
5. Click the button Claim Medical Credits in the box titled Claim Credits & Certificate. Choose the type of credit and click submit. Click the button View/Print Certificate to save or print your certificate. You can view/print your certificate at any time by visiting the ASAM eLearning Center, clicking Dashboard, and clicking Transcript/Achievements.

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CME, CE, CEU and Other Credit Types

ACCME Accreditation Statement
The American Society of Addiction Medicine is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

AMA Credit Designation Statement
The American Society of Addiction Medicine designates this journal-based CME for a maximum of 1 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

National Board for Certified Counselors ACEP
The American Society of Addiction Medicine has been approved by NBCC as an Approved Continuing Education Provider, ACEP No. 7062. Programs that do not qualify for NBCC credit are clearly identified. The American Society of Addiction Medicine is solely responsible for all aspects of the programs.

California Association for Drug/Alcohol Educators (CAADE)
This educational program is approved by CAADE: #CP40 999 1225.

California Association of DUI Treatment Centers (CADTP)
This educational program is approved by CADTP: #205.

California Consortium of Addiction Programs and Professionals (CCAPP)
This educational program is approved by CCAPP: #OS-20-330-1224.

Continuing Education Credits (CEUs)
Non-physician participants will receive a certificate of attendance upon completion of the activity and an online evaluation confirming their participation. Participants should submit his/her certificate of attendance to their professional organization/institute.

Maintenance of Certification (MOC) or Continuing Certification Programs (CCP)

American Board of Preventive Medicine (ABPM)
The American Board of Preventive Medicine (ABPM) has approved this activity for a maximum of 1 credit towards ABPM MOC Part II requirements.

American Board of Anesthesiology (ABA)
This activity contributes to the CME component of the American Board of Anesthesiology’s redesigned Maintenance of Certification in Anesthesiology TM (MOCA®) program, known as MOCA 2.0®.

American Board of Pediatrics (ABP)
Successful completion of this CME activity, which includes participation in the activity, with individual assessments of the participant and feedback to the participant, enables the participant to earn a maximum of 1 MOC point in the American Board of Pediatrics’ (ABP) Maintenance of Certification (MOC) program. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABP MOC credit.

American Board of Internal Medicine (ABIM)
Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to 1 Medical Knowledge MOC point in the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for the activity. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC credits.

American Board of Surgery (ABS)
Successful completion of this CME activity, which includes participation in the evaluation component, enables the learner to earn credit toward the CME and/or Self-Assessment requirements of the American Board of Surgery’s Continuous Certification program. It is the CME activity provider's responsibility to submit learner completion information to ACCME for the purpose of granting ABS credit.

American Board of Psychiatry and Neurology (ABPN)
Successful completion of this CME activity can be used to satisfy the American Board of Psychiatry and Neurology’s (ABPN) CME requirement for Maintenance of Certification program. 

American Board of Addiction Medicine (ABAM)
Successful completion of this activity can be used to satisfy the American Board of Addiction Medicine (ABAM) Tmoc credit requirements.

Royal College of Physicians and Surgeons of Canada (RCPSC)
Royal College Fellows can use participation in Accredited Continuing Medical Education to earn Section 3 Credits.

Disclosure Information

In accordance with disclosure policies of ASAM and the ACCME, the effort is made to ensure balance, independence, objectivity, and scientific rigor in all CME/CE activities. These policies include mitigating all possible relevant financial relationships with ineligible companies for the Planning Committees and Presenters. All activity Planning Committee members and Faculty have disclosed relevant financial relationship information. 

The Journal of Addiction Medicine has reviewed these disclosures and determined that the relationships are not inappropriate in the context of their respective presentations and are not inconsistent with the educational goals and integrity of the activity.