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Pharmacogenetics of smoking cessation in general practice: results from the patch II and patch in practice trials.

ABSTRACT: Cigarette smoking remains the leading cause of preventable death worldwide. However, the efficacy of available first-line therapies remains low, particularly in primary care practice where most smokers seek and receive treatment. These observations reinforce the notion that 'one size fits all' smoking cessation therapies may not be optimal. Therefore, a translational research effort was launched by the Imperial Cancer Research Fund (later Cancer Research UK) General Practice Research Group, who led a decade-long research enterprise that examined the influence of pharmacological hypothesis-driven research into genetic influences on drug response for smoking cessation with transdermal nicotine replacement therapy in general practice.New and previously published smoking cessation genetic association results of 30 candidate gene polymorphisms genotyped for participants in two transdermal nicotine replacement clinical trials based in UK general practices, which employed an intention to analyze approach.By this high bar, one of the polymorphisms (COMT rs4680) was robust to correction for multiple comparisons. Moreover, future research directions are outlined; and lessons learned as well as best-practice models for designing, analyzing, and translating results into clinical practice are proposed.The results and lessons learned from this general practice-based pharmacogenetic research programme provide transportable insights at the transition to the second generation of pharmacogenetic and genomic investigations of smoking cessation and its translation to primary care.

SUBMITTER: David SP

PROVIDER: S-EPMC3107615 | biostudies-literature | 2011 Mar

REPOSITORIES: biostudies-literature

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Pharmacogenetics of smoking cessation in general practice: results from the patch II and patch in practice trials.

David Sean P SP Johnstone Elaine C EC Churchman Michael M Aveyard Paul P Murphy Michael F G MF Munafò Marcus R MR

Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco 20110125 3

<h4>Introduction</h4>Cigarette smoking remains the leading cause of preventable death worldwide. However, the efficacy of available first-line therapies remains low, particularly in primary care practice where most smokers seek and receive treatment. These observations reinforce the notion that 'one size fits all' smoking cessation therapies may not be optimal. Therefore, a translational research effort was launched by the Imperial Cancer Research Fund (later Cancer Research UK) General Practice ...[more]

PMID: 21330274

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Project description:BackgroundVarenicline, a new treatment for smoking cessation, has demonstrated significantly greater efficacy over placebo and sustained release bupropion (bupropion SR). A study was undertaken to compare a 12-week standard regimen of varenicline with a 10-week standard regimen of transdermal nicotine replacement therapy (NRT) for smoking cessation.MethodsIn this 52-week, open-label, randomised, multicentre, phase 3 trial conducted in Belgium, France, The Netherlands, UK and USA, participants were randomly assigned (1:1) to receive varenicline uptitrated to 1 mg twice daily for 12 weeks or transdermal NRT (21 mg/day reducing to 7 mg/day) for 10 weeks. Non-treatment follow-up continued to week 52. The primary outcome was the biochemically confirmed (exhaled carbon monoxide < or = 10 ppm) self-reported continuous abstinence rate (CAR) for the last 4 weeks of the treatment period in participants who had taken at least one dose of treatment. Secondary outcomes included CAR from the last 4 weeks of treatment through weeks 24 and 52, and measures of craving, withdrawal and smoking satisfaction.ResultsA total of 376 and 370 participants assigned to varenicline and NRT, respectively, were eligible for analysis. The CAR for the last 4 weeks of treatment was significantly greater for varenicline (55.9%) than NRT (43.2%; OR 1.70, 95% CI 1.26 to 2.28, p<0.001). The week 52 CAR (NRT, weeks 8-52; varenicline, weeks 9-52) was 26.1% for varenicline and 20.3% for NRT (OR 1.40, 95% CI 0.99 to 1.99, p = 0.056). Varenicline significantly reduced craving (p<0.001), withdrawal symptoms (p<0.001) and smoking satisfaction (p<0.001) compared with NRT. The most frequent adverse event was nausea (varenicline, 37.2%; NRT, 9.7%).ConclusionsThe outcomes of this trial established that abstinence from smoking was greater and craving, withdrawal symptoms and smoking satisfaction were less at the end of treatment with varenicline than with transdermal NRT.Trial registration numberNCT00143325.

Project description:BackgroundFew European smokers receive professional counselling when attempting to quit smoking, resulting in suboptimal success rates and poor health outcomes. Healthcare providers in general practice play an important role in referring smokers to smoking cessation counselling. We chose the Netherlands as a case study to qualitatively explore which factors play a role among healthcare providers in general practice with regard to referral for smoking cessation counselling organised both inside and outside general practice.MethodsWe conducted four focus groups and 18 telephone interviews, with a total of 31 healthcare providers who work in general practice. Qualitative content analysis was used to identify relevant factors related to referral behaviours, and each factor was linked to one of the three main components of the COM-B behaviour model (i.e., capability, opportunity and motivation) as well as the six sub-components of the model.ResultsDutch healthcare providers in general practice typically refer smokers who want to quit to counselling inside their own general practice without actively discussing other counselling options, indicating a lack of shared decision making. The analysis showed that factors linked to the COM-B main components 'capability' and 'opportunity', such as healthcare providers' skills and patients' preferences, play a role in whether patients are referred to counselling inside general practice. Factors linked to all three COM-B components were found to play a role in referrals to counselling outside general practice. These included (knowledge of) the availability and quality of counselling in the region, patients' requests, reimbursement, and sense of urgency to refer. The identified factors can both act as barriers and facilitators.ConclusionsThe findings of this research suggest that more smokers can be reached with smoking cessation counselling if implementation interventions focus on: (i) equipping healthcare providers with the knowledge and skills needed to refer patients; (ii) creating more opportunities for healthcare providers to refer patients (e.g., by improving the availability and reimbursement of counselling options); and (iii) motivating healthcare providers to discuss different counselling options with patients.

Project description:ObjectiveAlthough smoking cessation is a key priority emphasized by professional societies and multidisciplinary consensus guidelines, significant variation exists in the methods and efficacy of smoking cessation treatment practiced by vascular surgeons. We conducted a series of patient, surgeon, and nonpatient stakeholder focus groups to identify important domains for establishment of a successful smoking cessation program.MethodsAs part of a planning effort for a randomized clinical trial on usual care vs a standardized, evidence-based smoking cessation intervention, our group performed a series of interviews and focus groups. These were four 1-hour interviews, conducted with stakeholders such as tobacco cessation counselors (n = 2), a Quit Line representative (n = 1), and a Vascular Quality Initiative leader (n = 1), as well as two 90-minute, formal, professionally moderated focus groups, one with vascular surgeons (n = 7), and another with patients (n = 4). Transcripts and audio recordings were qualitatively reviewed for themes to establish the most important domains perceived to be associated with a successful smoking cessation program.ResultsPatients emphasized four domains critical for a successful smoking cessation program: the motivation to quit, an individualized approach, the timing of an intervention, and the tone of the physician who offers counseling. Although surgeons and nonpatient stakeholders also emphasized the importance of a compassionate physician tone, surgeons and nonpatient stakeholders differed from patients in their remaining domains. They emphasized the feasibility of a brief intervention in a busy clinical practice, implementation of the effort, and necessary infrastructure for smoking cessation programs. All focus group participants described a brief, evidence-based smoking cessation intervention as feasible in routine vascular practice.ConclusionsDifferences in motivation and significance exist for patients, surgeons, and stakeholders when they considered the specific domains most important in building a successful smoking cessation program. Despite these differences, all parties involved agreed that a brief, standardized intervention can be successful delivered in a busy vascular clinic setting.

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Pharmacogenetics of smoking cessation in general practice: results from the patch II and patch in practice trials.

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Pharmacogenetics of smoking cessation in general practice: results from the patch II and patch in practice trials.

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