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CME/CE

Nicotine Patch Plus Lozenge Best Therapy for Smoking Cessation

  • Authors: News Author: Pauline Anderson
    CME Author: Charles P. Vega, MD
  • CME/CE Released: 11/10/2009
  • THIS ACTIVITY HAS EXPIRED
  • Valid for credit through: 11/10/2010
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Target Audience and Goal Statement

This article is intended for primary care clinicians, addiction medicine specialists, and other specialists who care for patients who smoke.

The goal of this activity is to provide medical news to primary care clinicians and other healthcare professionals in order to enhance patient care.

Upon completion of this activity, participants will be able to:

  1. Describe the effect of clinician advice on improving rates of smoking cessation.
  2. Compare common treatments used for smoking cessation.


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Author(s)

  • Pauline Anderson

    Pauline Anderson is a freelance writer for Medscape.

    Disclosures

    Disclosure: Pauline Anderson has disclosed no relevant financial information.

Editor(s)

  • Brande Nicole Martin

    is the News CME editor for Medscape Medical News.

    Disclosures

    Disclosure: Brande Nicole Martin has disclosed no relevant financial information.

CME Author(s)

  • Charles P. Vega, MD

    Associate Professor and Residency Director, Department of Family Medicine, University of California-Irvine, Irvine California

    Disclosures

    Disclosure: Charles P. Vega, MD, has disclosed no relevant financial relationships.

CME Reviewer(s)

  • Laurie E. Scudder, MS, NP

    Accreditation Coordinator, Continuing Professional Education Department, MedscapeCME; Clinical Assistant Professor, School of Nursing and Allied Health, George Washington University, Washington, DC; Nurse Practitioner, School-Based Health Centers, Baltimore City Public Schools, Baltimore, Maryland

    Disclosures

    Disclosure: Laurie E. Scudder, MS, NP, has disclosed no relevant financial relationships.

Nurse Planner

  • Laurie E. Scudder, MS, NP

    Accreditation Coordinator, Continuing Professional Education Department, MedscapeCME; Clinical Assistant Professor, School of Nursing and Allied Health, George Washington University, Washington, DC; Nurse Practitioner, School-Based Health Centers, Baltimore City Public Schools, Baltimore, Maryland

    Disclosures

    Disclosure: Laurie E. Scudder, MS, NP, has disclosed no relevant financial relationships.


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CME/CE

Nicotine Patch Plus Lozenge Best Therapy for Smoking Cessation

Authors: News Author: Pauline Anderson CME Author: Charles P. Vega, MDFaculty and Disclosures
THIS ACTIVITY HAS EXPIRED

CME/CE Released: 11/10/2009

Valid for credit through: 11/10/2010

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November 10, 2009 — An important head-to-head study of smoking cessation therapies shows that combination treatment with a nicotine patch plus lozenge almost doubles the rate of abstinence at 6 months compared with placebo, new research suggests.

"This is the first time that a head-to-head study has been done looking at all the different smoking cessation pharmacotherapies, and it's also one of the first times that combination therapies have been looked at in a large sample," said lead author Megan E. Piper, PhD, assistant professor, Center for Tobacco Research and Intervention, School of Medicine and Public Health, University of Wisconsin, Madison.

"When you get a 40% quit rate at 6 months in a group, that's really promising for smokers who are trying so hard to quit."

The study was published in the November issue of the Archives of General Psychiatry.

The trial included 1504 adults who smoked an average of 10 or more cigarettes a day for at least the past 6 months and were randomly assigned to 1 of 6 interventions:

  • bupropion SR (sustained release; Zyban, GlaxoSmithKline), 150 mg twice daily for 1 week before a target quit date and 8 weeks after the quit date;
  • nicotine lozenge (2 or 4 mg) for 12 weeks after the quit date;
  • nicotine patch (24-hour, 21, 14, and 7 mg titrated down during 8 weeks after quitting;
  • nicotine patch plus nicotine lozenge;
  • bupropion SR plus nicotine lozenge; or
  • placebo (1 matched to each of the 5 treatments).

Patients also received six 10- to 20-minute individual counseling sessions, with the first 2 sessions scheduled before quitting.

The protocol included 3 in-person baseline sessions, during which researchers collected relevant medical history and vital signs measurements and carried out a carbon monoxide breath test. The last baseline visit took place between 8 and 15 days before the quit date.

Patients had study visits on their quit day and at 1, 2, 4, and 8 weeks postquit, during which vital signs, adverse events, and smoking status were recorded.

Measures of Success

The researchers looked at several measures of cessation success including being able to quit for 1 week after the designated quit date; being abstinent for at least 1 day during the first week of an attempt to quit; the time to first lapse, defined as the first cigarette smoked after quitting; and the time to relapse, defined as smoking on 7 consecutive days after the quit date.

During treatment, the patch, bupropion plus lozenge, and patch plus lozenge were all significantly more efficacious than placebo, but at 6 months, or 4 months after the end of treatment, only the patch plus lozenge remained efficacious.

The carbon monoxide–confirmed abstinence rates at 6 months were 40.1% for the patch plus lozenge, 34.4% for the patch alone, 33.5% for the lozenge alone, 33.2% for bupropion plus lozenge, 31.8% for bupropion alone, and 22.2% for placebo;

The odds ratio at 6 months was highest (OR, 2.34) in the combination patch plus lozenge group, followed by the patch alone (OR, 1.83), lozenge alone (OR, 1.76), bupropion plus lozenge (OR, 1.74), and bupropion alone (OR, 1.63) compared with placebo.

This patch/lozenge combination came out ahead in a number of other measurements. It, along with the patch alone, was the most effective at helping patients stay abstinent for at least 1 day during the first week of an attempt to quit. In addition, the combination tended to produce more positive outcomes than other treatments on days to lapse and days to relapse.

Safe and Well Tolerated

All the interventions appeared safe and well tolerated. Only 4 of 1504 participants withdrew from the study for medication-related reasons.

People who had tried to quit before this study were evenly distributed in the various treatment groups, so the success rate was not a result of it just being the right time to quit for subjects.

"Let's say everyone was going to quit if it was their sixth time, but we randomly dispersed all the people who were at their sixth time across all the different treatment conditions, so that shouldn't have too much of an impact in terms of comparing the conditions," said Dr. Piper.

Successfully quitting after several failed attempts could at least partially be attributed to "skill building," she said. "Some of it is just learning the triggers, learning what you can and can't do and still be able to stay smoke free, and learning how to cope with withdrawal over time."

Additive Effect

The authors speculate that the patch/lozenge combination might produce an additive effect. "When you put a patch on, it's steadily putting nicotine into your blood, and so it's generally taking the edge off some of your withdrawal all the time," said Dr. Piper. "But some people have times when they always have a cigarette — after a meal or when stressed at work, for example. These people can use the lozenge instead of going for a cigarette in those moments of intense craving."

Dr. Piper believes that the counseling sessions played an important role in successful smoking cessation. Some healthcare providers provide such counseling, but smokers across the country can also access a national quit line (1-800-QUITNOW) that provides over-the-phone coaching. "And if you're interested in face-to-face counseling, they will help you locate clinics or groups or classes in your area."

All the treatment interventions used in the study, except for bupropion, are available without prescription, and most are covered by health insurance plans, said Dr. Piper.

Varenicline Not Included

It is unfortunate that the study did not include varenicline (Chantix, Pfizer), commented Alexander Glassman, MD, head of clinical psychopharmacology at New York State Psychiatric Institute and professor of psychiatry, Columbia University, New York City.

"Studies show that this drug used alone is superior to bupropion, although these studies excluded patients with depression and schizophrenia, many of whom smoke," he said.

As for recent concerns about the safety of this drug, Dr. Glassman said reports during phase 4 (postmarketing) evaluation are "notoriously unreliable."

This new comparison study reinforces the notion that combination therapies are superior to single therapies, said Dr. Glassman, who runs a smoking cessation research clinic and has done research on smoking and depression. He noted that although the patch plus lozenge was superior to other treatments, the other combination used in the study — bupropion plus lozenge — also fared well.

After reading the study, Dr. Glassman will consider using the lozenge more often in his practice. "The authors convincingly showed that the lozenge can work just as well as bupropion as an add-on treatment or as a combination treatment," he said.

The lozenge is a relative newcomer to the smoking cessation scene and may not be as well known or as commonly used as the patch, he said. The lozenge is better than nicotine gum, as the release of nicotine is controlled and not dependent on chewing method.

Dr. Glassman stressed that not all smoking cessation tools work for everyone. "Some people have trouble with the lozenge — they get nauseated — and some people will feel jumpy and not sleep well on the bupropion."

Authors of the study have disclosed that they have received research support from Elan Corporation, the National Institute on Drug Abuse, the National Cancer Institute, Pfizer Inc, Sanofi-Synthelabo, and Nabi Biopharmaceuticals; served as an investigator on research projects sponsored by Sanofi-Synthelabo, Pfizer Inc, and Nabi Biopharmaceuticals; received support for educational activities from the National Institute on Drug Abuse and the Veterans Administration; received consulting fees from Nabi Biopharmaceuticals; received honoraria from Pfizer; served as an investigator on research studies at the University of Wisconsin that were funded by Pfizer, Sanofi-Synthelabo, GlaxoSmithKline, and Nabi Biopharmaceuticals; and been appointed to a named chair funded by an unrestricted gift to the University of Wisconsin from Glaxo Wellcome.

Arch Gen Psychiatry. 2009;66:1253–1262. Abstract

Additional Resource

More information on smoking cessation is avaiable on MedlinePlus.

Clinical Context

Smoking cessation is paramount to achieving good health, and the current study compares different adjunctive medical treatments to help patients quit. But can simple advice from a clinician promote higher rates of smoking cessation? A review by Stead and colleagues, which was published in the April 16, 2008, issue of the Cochrane Database of Systematic Reviews, suggests that the answer is yes. Data from 17 trials of brief advice regarding smoking cessation demonstrated that this simple intervention yielded a 66% increase in the abstinence rate. More intensive counseling programs were slightly more effective than minimal advice alone, and there was also the suggestion of a small benefit of follow-up visits to monitor patients' progress. However, mortality rates were not significantly reduced by smoking cessation advice in the 1 study that measured this outcome.

In addition to advice, many patients receive medical therapy to help them achieve their goal of smoking cessation. However, there is a paucity of data comparing available treatments. The current trial addresses this issue.

Study Highlights

  • Researchers recruited individuals in Wisconsin who smoked more than 9 cigarettes per day for at least 6 months and were motivated to quit smoking. Individuals with significant psychiatric or cardiac conditions were excluded from study participation, as were individuals who consumed alcohol at high levels.
  • Participants were randomly assigned in a double-blind fashion to one of the following interventions:
    • Bupropion SR 150 mg twice daily for 9 weeks
    • Nicotine lozenges 2 to 4 mg, 9 times daily for 12 weeks
    • 24-hour nicotine patches titrated downward from 21 mg to 7 mg for 8 weeks
    • Nicotine patches plus nicotine lozenges
    • Bupropion SR plus nicotine lozenges
    • 1 of 5 different placebo interventions matched to active treatments
  • All study treatments were begun on the quit date, except for bupropion, which was initiated 1 week before quitting.
  • All participants received 6 counseling sessions regarding smoking cessation. Each counseling session lasted 10 to 20 minutes.
  • The main outcome of the study was biochemically confirmed 7-day point-prevalence abstinence assessed at 1 week, 8 weeks, and 6 months after the quit date. Researchers also observed the number of participants who were able to quit for at least 1 day during the first week as well as the number of days to relapse.
  • 1504 adults participated in the study. Baseline demographic and smoking data were similar between intervention groups. The mean age was 44.7 years. 58% of subjects were women, and 83% were white. The mean number of cigarettes smoked per day was 21.4, and participants had an average of nearly 6 previous attempts to quit smoking.
  • More than 80% of participants in each treatment group were able to quit smoking for at least 1 day during the first week. The highest rate of initial cessation was in the nicotine patch plus lozenge group (91.5%).
  • There was a strong placebo response, with an abstinence rate of 22.2% at 6 months among participants receiving placebo.
  • Nonetheless, all active interventions were significantly more effective than placebo. Gross abstinence rates at 1 week, 8 weeks, and 6 months, respectively, were as follows:
    • Placebo: 23.3%, 30.2%, and 22.2%
    • Bupropion alone: 34.5%, 40.2%, and 31.8%
    • Nicotine lozenge alone: 29.2%, 40.4%, and 33.5%
    • Nicotine patch alone: 40.5%, 44.7%, and 34.4%
    • Bupropion plus lozenge: 37.4%, 50.4%, and 33.2%
    • Nicotine patch plus lozenge: 43.4%, 53.6%, and 40.1%
  • On logistic regression analyses, the nicotine patch-plus-lozenge combination was associated with significantly higher rates of abstinence during week 1 and at 6 months vs study monotherapies. The patch plus lozenge also was superior to monotherapy in lengthening the latency period to resume smoking.
  • Overall treatment adherence was 77%. Adherence to lozenges was lower vs the other study interventions, which might be explained by the frequent dosing schedule of the lozenges.
  • Study treatments were generally well tolerated. There was 1 serious event (seizure), possibly related to study treatment. However, only 4 people withdrew from the trial because of medication-related adverse events.

Clinical Implications

  • Previous research demonstrates that brief advice from a clinician is effective to help smokers quit, and adding more intensive counseling and follow-up visits provides a small relative benefit to brief advice alone. However, no study to date has demonstrated that brief advice regarding smoking cessation reduces mortality rates.
  • Although bupropion SR, nicotine patches, nicotine lozenges, and combination treatment with bupropion SR plus nicotine lozenges and nicotine patches plus nicotine lozenges were all more effective than placebo in promoting abstinence from smoking in the current trial, the combination of nicotine patches with nicotine lozenges was most effective.

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