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ABSTRACT: BACKGROUND Reductions in admissions for myocardial infarction (MI) have been reported in locales where smoke-free workplace laws have been implemented, but no study has assessed sudden cardiac death in that setting. In 2002, a smoke-free restaurant ordinance was implemented in Olmsted County, Minnesota, and in 2007, all workplaces, including bars, became smoke free. METHODS To evaluate the population impact of smoke-free laws, we measured, through the Rochester Epidemiology Project, the incidence of MI and sudden cardiac death in Olmsted County during the 18-month period before and after implementation of each smoke-free ordinance. All MIs were continuously abstracted and validated, using rigorous standardized criteria relying on biomarkers, cardiac pain, and Minnesota coding of the electrocardiogram. Sudden cardiac death was defined as out-of-hospital deaths associated with coronary disease. RESULTS Comparing the 18 months before implementation of the smoke-free restaurant ordinance with the 18 months after implementation of the smoke-free workplace law, the incidence of MI declined by 33% (P < .001), from 150.8 to 100.7 per 100 000 population, and the incidence of sudden cardiac death declined by 17% (P = .13), from 109.1 to 92.0 per 100 000 population. During the same period, the prevalence of smoking declined and that of hypertension, diabetes mellitus, hypercholesterolemia, and obesity either remained constant or increased. CONCLUSIONS A substantial decline in the incidence of MI was observed after smoke-free laws were implemented, the magnitude of which is not explained by community cointerventions or changes in cardiovascular risk factors with the exception of smoking prevalence. As trends in other risk factors do not appear explanatory, smoke-free workplace laws seem to be ecologically related to these favorable trends. Secondhand smoke exposure should be considered a modifiable risk factor for MI. All people should avoid secondhand smoke to the extent possible, and people with coronary heart disease should have no exposure to secondhand smoke.
Archives of internal medicine 10/2012; · 11.46 Impact Factor
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ABSTRACT: Pharmacotherapy trials for treating tobacco dependence would benefit from behavioral interventions providing treatment consistent with clinical practice guidelines but not directing participants to treatments not evaluated in the trial. The Smoke Free and Living It© behavioral intervention manual includes participant and interventionist guides and is designed to provide both practical counseling and intra-treatment support. We utilized this intervention manual in a multicenter, randomized clinical trial of smokers with attention deficit hyperactivity disorder. In this study, we evaluated how the interventional manual performed in a "train-the-trainer" model requiring uniform counseling across 6 sites and 15 interventionists. We analyzed the skill-adherence of the interventionists and the intervention-adherence of the participants. The 255 randomized participants completed 9.3±2.8 sessions (mean±SD), with 157 participants (61.6%) completing all 11 of the sessions and 221 (86.7%) completing at least 6 of the 11 sessions. Of the 163 sessions for which the study interventionists were evaluated, 156 (95.7%) were rated as adherent to protocol and "meeting expectations" on at least 6 of 7 established criteria, illustrating that fidelity can be maintained with minimal supervision. The self-help and interventionists guides of the Smoke Free and Living It manual can thus be used to provide behavioral intervention with a high rate of adherence by both the interventionists and the participants. This manual meets the requirements of the United States Public Health Service Clinical Practice Guideline, can be adapted to specific research protocols, and provides a useful option for behavioral intervention during clinical trials for smoking cessation.
Contemporary clinical trials 03/2012; 33(4):576-82. · 1.51 Impact Factor
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ABSTRACT: Tobacco use is a chronic medical disorder. Providing evidence-based treatment of tobacco-dependent patients is a challenge, and a team approach provides an efficient treatment model. Tobacco treatment specialists could expand the collective tobacco treatment expertise in the medical setting. Effective tobacco dependence treatment frequently requires tailoring and intensifying of interventions to meet the needs of the individual patient. Stopping smoking reduces the risk of lung cancer and many other cancers, cardiovascular disease, stroke, peripheral vascular disease. Treating tobacco dependence is one of the most cost-effective therapies in medicine and it deserves adequate reimbursement for it to be more widely available.
Clinics in chest medicine 12/2011; 32(4):645-57. · 2.51 Impact Factor
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ABSTRACT: Indonesia is the world's fifth largest cigarette market in the world but for decades, transnational tobacco companies (TTCs) have had limited success infiltrating this market, due to their inability to compete in the kretek market. Kreteks are clove/tobacco cigarettes that most Indonesians smoke.
To determine how Phillip Morris International (PMI) and British American Tobacco (BAT) have now successfully achieved a substantial market presence in Indonesia.
We analyzed previously secret, tobacco industry documents, corporate reports on Indonesia operations, the Tobacco Trade press, Indonesia media, and "The Roadmap".
Internal, corporate documents from BAT and PMI demonstrate that they had known for decades that kreteks are highly carcinogenic. Despite that knowledge, BAT and PMI now own and heavily market these products, as well as new more westernised versions of kreteks. BAT and PMI used their successful basic strategy of keeping cigarettes affordable by maintaining the social responsibility of smoking and opposing smoke-free workplace laws but in the 21st century, they added the acquisition of and westernisation of domestic kretek manufacturers as an additional strategy. These acquisitions allowed them to assert influences on health policy in Indonesia and to grow their business under current government policy embodied in the 2007-2020 Roadmap of Tobacco Products Industry and Excise Policy which calls for increased cigarette production by 12% over the next 15 years.
PMI and Bat have successfully entered and are expanding their share in the Indonesia cigarette market. Despite the obvious and pervasive influence of the tobacco industry on policy decisions, the Indonesian government should ratify the FCTC and implement effective legislation to reduce tobacco consumption and exposure to tobacco smoke and revise the Roadmap to protect future generations of Indonesians.
Tobacco control 08/2011; 21(3):306-12. · 3.85 Impact Factor
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ABSTRACT: Zebrafish are emerging as a powerful animal model for studying the molecular and physiological effects of nicotine exposure. The zebrafish have many advantageous physical characteristics, including small size, high fecundity rates, and externally developing transparent embryos. When combined with a battery of molecular-genetic tools and behavioral assays, these attributes enable studies to be conducted that are not practical using traditional animal models.
We reviewed the literature on the application of the zebrafish model as a preclinical model to study the biological effects of nicotine exposure.
The identified studies used zebrafish to examine the effects of nicotine exposure on early development, addiction, anxiety, and learning. The methods used included green fluorescent protein-labeled proteins to track in vivo nicotine-altered neuron development, nicotine-conditioned place preference, and locomotive sensitization linked with high-throughput molecular and genetic screens and behavioral models of learning and stress response to nicotine. Data are presented on the complete homology of all known human neural nicotinic acetylcholine receptors in zebrafish and on the biological similarity of human and zebrafish dopaminergic signaling.
Tobacco dependence remains a major health problem worldwide. Further understanding of the molecular effects of nicotine exposure and genetic contributions to dependence may lead to improvement in patient treatment strategies. While there are limitations to the use of zebrafish as a preclinical model, it should provide a valuable tool to complement existing model systems. The reviewed studies demonstrate the enormous opportunity zebrafish have to advance the science of nicotine and tobacco research.
Nicotine & Tobacco Research 03/2011; 13(5):301-12. · 2.58 Impact Factor
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ABSTRACT: To compare the effectiveness of outpatient vs residential treatment for tobacco dependence in a large referral practice.
We analyzed data from 2 cohorts of cigarette smokers who received either comprehensive outpatient or intensive 8-day residential treatment for tobacco dependence between January 1, 2004, and December 31, 2007. Self-reported 7-day point prevalence abstinence from smoking at 6 months was obtained via telephone interview. Logistic regression was used to assess the likelihood of increased abstinence with residential treatment.
Overall, 4327 cigarette smokers received comprehensive outpatient treatment for tobacco dependence, and 226 smokers received treatment in an intensive 8-day residential program. Compared with outpatients, residential patients smoked more cigarettes per day (mean ± SD, 31.1 ± 14.4 vs 21.2 ± 11.2), had more severe nicotine dependence (Fagerström Test for Nicotine Dependence score, 6.9 ± 2.0 vs 5.1 ± 2.3), and were more likely to have been treated for alcoholism (58/222 [26%] vs 649/4327 [15%]) or depression (124/222 [56%] vs 1817/4327 [42%]; P<.001 for all comparisons). The 6-month smoking abstinence rate was significantly higher for residential patients compared with outpatients (115/222 [52%] vs 1168/4327 [27%]; unadjusted odds ratio, 3.0; 95% confidence interval, 2.3-3.9), with similar findings after adjusting for baseline characteristics (adjusted odds ratio, 3.58; 95% confidence interval, 2.6-4.9).
Compared with smokers who received outpatient treatment, those who received residential treatment had more severe tobacco dependence. Residential treatment for tobacco dependence was associated with a significantly greater odds of 6-month smoking abstinence compared with outpatient treatment among smokers in a referral clinic setting.
Mayo Clinic Proceedings 02/2011; 86(3):203-9. · 5.70 Impact Factor
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ABSTRACT: Methylphenidate blocks the re-uptake of dopamine by binding to the dopamine transporter in the presynaptic cell membrane and increases extracellular dopamine levels. Similarities in neuropsychologic effects between nicotine and methylphenidate make it an intriguing potential therapeutic option. Previous research of methylphenidate in smokers has suggested a possible beneficial effect for the relief of nicotine withdrawal symptoms, but showed no efficacy in helping smokers with attention deficit hyperactivity disorder (ADHD) to stop smoking.
To investigate potential efficacy for relieving nicotine withdrawal symptoms and promoting smoking abstinence, we conducted a randomized, double-blind, placebo-controlled, phase II study of once-a-day osmotic-release oral system methylphenidate (OROS-MPH, Concerta®) at a target dose of 54-mg/day for 8 weeks compared with placebo in 80 adult cigarette smokers.
Of the 80 randomized subjects and median smoking rate was 20 cigarettes per day. At the end of the medication phase, the biochemically confirmed 7-day point prevalence smoking abstinence was 10% (4/40) for the placebo group and 2.5% (1/40) for the OROS-MPH group. Nicotine withdrawal was not found to differ significantly between treatment groups during the first 14 days following the start of medication prior to the target quit date (p = 0.464) or during the first 14 days following the target quit date (p = 0.786).
We observed no evidence of efficacy of OROS-MPH to aid smokers to stop smoking. Although there are biologically plausible hypotheses that support the use of OROS-MPH for treating tobacco dependence, we found no evidence to support such hypotheses. In addition to no increase in smoking abstinence, we saw no effect of OROS-MPH for tobacco withdrawal symptom relief and no change in smoking rates was observed in the OROS-MPH group compared to the placebo group.
Journal of Negative Results in BioMedicine 01/2011; 10:1. · 1.47 Impact Factor
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ABSTRACT: The purpose of this study was to obtain preliminary evidence of the efficacy of a 12-week course of varenicline for 7-day point prevalence smoking abstinence among recovering alcohol-dependent smokers. We enrolled 32 smokers with 6 months or more of recovery from alcohol dependence in an open-label clinical trial. Participants received varenicline 1 mg twice daily and 12 weeks of behavioral counseling. Participants were 69% men, 94% Caucasian, and smoking an average of 20.3 ± 5.0 cigarettes per day. After 12 weeks of treatment, 31% were biochemically confirmed 7-day point prevalence abstinent from smoking and 28% had prolonged smoking abstinence (2 weeks after target quit date onward). The most common adverse effects were mild to moderate nausea (28%) and sleep disturbance (19%). No serious adverse events were reported. Varenicline may be a useful aid for treating tobacco dependence among smokers who are in stable recovery from alcohol dependence. Further study of this treatment is warranted.
Journal of substance abuse treatment 10/2010; 40(1):102-7. · 2.90 Impact Factor
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ABSTRACT: The impact of social support on successful smoking cessation has been well documented. However, little is known about whether personal experience with cancer may motivate cancer survivors to support smoking cessation among their family members and friends. As a first step in this line of research, we sought to explore interest in playing a supportive role for smoking cessation as well as correlates of such interest among cancer survivors.
Cancer survivors undergoing radiation therapy (N=211) completed a 77-item pencil-paper questionnaire. A section of the survey assessed interest in helping a smoker quit and characteristics of the smoking social network member. Respondents provided information on their smoking status, medical status, and psychosocial and behavioral factors related to cigarette smoking.
Over half of the respondents 114 (54%) reported having someone close to them (family member or friend) smoking cigarettes who they thought should quit. Of these respondents (44 females, 70 males) 78% (89/114) reported they were definitely or probably interested in helping a smoker quit. Nearly all respondents wanted to help a family member (typically an adult child).
Results suggest the potential feasibility of engaging cancer survivors to help family members quit smoking. Research is needed to determine the optimal methods and timing for engaging the cancer patient to maximize positive effects and minimize potential harms.
Psycho-Oncology 05/2010; 20(7):724-9. · 3.34 Impact Factor
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ABSTRACT: Globally, tobacco kills almost 5 million people around the world annually. Seven first-line pharmacotherapies are currently available and recommended by the United States Public Health Service (USPHS) clinical practice guideline for treating tobacco dependence, all of which have been proven to be effective for increasing tobacco abstinence rates when used as monotherapy. However, not all smokers are able to quit with single-drug therapy. Some smokers may benefit from combination therapy that includes the simultaneous use of different nicotine replacement therapies (NRTs) or medications with different mechanisms of action (e.g. NRT and bupropion). Combination therapy with different types of NRT may provide a therapeutic advantage by increasing serum nicotine concentrations, and combination therapy with different drugs may capitalize on synergy obtained from two different mechanisms of action. However, controversy exists regarding this approach. Available data suggests that combination therapy may increase abstinence rates compared with monotherapy. However, the cost effectiveness of this approach has not been clearly demonstrated.
Drugs 04/2010; 70(6):643-50. · 4.23 Impact Factor
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ABSTRACT: BACKGROUND: This study evaluates differences in smoking abstinence between white and minority smokers using pharmaceutical aids. METHODS: This is an analysis of data from a multi-center, randomized, clinical trial conducted in the United States. Of the 1,684 subjects randomized to one of three medications (nicotine inhaler, bupropion, or a combination of both), 60% were women and 10% were minority races. RESULTS: Factors associated with a decreased likelihood of smoking at 12 weeks were older age (OR = 0.971, p < 0.0001), being married (OR = 0.678, p = 0.0029), using bupropion SR (OR = 0.480, p < 0.0001), and using combination therapy (OR = 0.328, p < 0.0001). Factors associated with an increased likelihood of smoking were higher tobacco dependence scores (OR = 1.244, p < 0.0001), prior quit attempts (OR = 1.812, p = 0.004), and being a minority (OR = 1.849, p = 0.0083). Compared to white smokers, minority smokers were significantly older at time of study entry (46 vs. 42 years, p < 0.0001), less likely to be married (35% vs. 59%, p < 0.0001), older at smoking initiation (21 vs. 19 years of age, p < 0.0001), and had a lower abstinence rate (16% vs. 26%, p = 0.0065). CONCLUSION: Regardless of the treatment used, minority smokers in the US have lower smoking abstinence after treatment for tobacco dependence. Future research should focus on the improvement in treatment strategies for minority smokers.
Community Medicine 02/2010; 18(1):59-68. · 1.23 Impact Factor
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ABSTRACT: Smoking is the leading preventable cause of morbidity and mortality in the US, and decreasing smoking prevalence is a public health priority. Patients achieve the greatest success when quit attempts involve behavioral therapy combined with pharmacotherapy. Varenicline is the most recent addition to the pharmacotherapeutic armamentarium for the treatment of tobacco dependence. Varenicline is efficacious and cost-effective. Smoking relapse and adverse treatment-related side effects may decrease medication adherence and patient satisfaction with varenicline. In the clinical setting, varenicline treatment can be optimized by reducing doses in patients who experience intolerable side effects, increasing the dose in partial responders, and providing long-term maintenance therapy for relapse prevention.
Patient Preference and Adherence 01/2010; 4:355-62. · 1.14 Impact Factor
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ABSTRACT: While Spain's national tobacco control legislation prohibits smoking in many indoor public places, the law provides for an exception to the prohibition of smoking by allowing separate seating sections and ventilation options in certain public places such as bars and restaurants, hotels and airports. Accordingly, Spain's law is not aligned with Article 8 Guidelines of the World Health Organization's Framework Convention on Tobacco Control, which requires parties to ensure universal protection against secondhand smoke exposure in all enclosed public places, workplaces and on all means of public transport. Spain's law is currently being promoted by the tobacco companies in other countries as a model for smoke-free legislation. In order to prevent weakening of smoke-free laws in other countries through industry-supported exceptions, we investigated the tactics used by the tobacco companies before the implementation of the new law and assessed the consequences of these actions in the hospitality sector. Internal tobacco industry documents made public through US litigation settlements dating back to the 1980s were searched in 2008-9. Documents show that tobacco companies sought to protect hospitality venues from smoking restrictions by promoting separate seating for smokers and ineffective ventilation technologies, supporting an unenforceable voluntary agreement between the Madrid local government and the hospitality industry, influencing ventilation standards setting and manipulating Spanish media. The Spanish National Assembly should adopt comprehensive smoke-free legislation that does not accommodate the interests of the tobacco industry. In doing so, Spain's smoke-free public places law would be better aligned with the Framework Convention on Tobacco Control.
Tobacco control 10/2009; 19(1):24-30. · 3.85 Impact Factor
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ABSTRACT: The US Public Health Service Guideline for Treating Tobacco Use and Dependence 2008 Update emphasizes tobacco use as a chronic medical disorder; highlights both behavioral counseling and the use of 1 or more of the 7 approved medications; and points out the utility, efficacy, and reach of telephone quitlines. The treatment of users of smokeless tobacco continues to be less than optimal. Although providing evidence-based treatment for tobacco- dependent patients is a challenge for busy physicians, a team approach including trained and certified tobacco treatment specialists (TTS) provides an efficient treatment model. TTS represent a new and growing part of the health care team and hold great potential for expanding the collective tobacco treatment expertise in the medical setting. The effective treatment of tobacco dependence frequently requires tailoring, and often intensifying, interventions (both counseling and pharmacotherapy) to meet the needs of the individual patient.
CA A Cancer Journal for Clinicians 09/2009; 59(5):314-26. · 101.78 Impact Factor
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ABSTRACT: Studies examining the efficacy of tobacco dependence treatment among recovering alcoholic smokers have produced mixed findings. We set out to investigate this issue further by conducting a randomized, double-blind, placebo-controlled trial of bupropion sustained-release (SR) for smoking relapse prevention among abstinent alcoholic smokers.
Participants (N = 195) met DSM-IV criteria for a history of alcohol abuse or dependence and had at least 1 year of continuous abstinence from alcohol and drugs. Open-label treatment with nicotine patch therapy was provided to all subjects for 8 weeks. The initial nicotine patch dose was determined by the subject's baseline serum cotinine concentration with an aim to achieve 100% cotinine replacement. All subjects who were confirmed abstinent from smoking throughout the final week of nicotine patch therapy (Week 8) were randomly assigned to receive bupropion SR 300 mg/day or placebo through Week 52.
A total of 110 participants were randomized to the double-blind treatment. No significant difference was observed between the bupropion and placebo groups for rates of continuous smoking abstinence, 41.1% (95% CI = 28.1%-55.0%) versus 40.7% (95% CI = 27.6%-55.0%), respectively, p = 1.0, or point prevalence abstinence, 39.3% (95% CI = 26.5%-53.3%) versus 40.7% (95% CI = 27.6%-55.0%), respectively, p = 1.0, at the end of the treatment (Week 52). Relapse to alcohol occurred in 4% of subjects (n = 4) during the study.
Treatment with bupropion SR among abstinent alcoholic smokers did not delay relapse or result in improved long-term smoking abstinence.
Nicotine & Tobacco Research 08/2009; 11(7):859-67. · 2.58 Impact Factor
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ABSTRACT: The purpose of this study was to assess the predictive value of smoking history on breast cancer diagnosis in a referral clinic population. We conducted a case-control study using clinical data collected on 8,097 female patients (1,225 breast cancer cases and 6,872 controls) seen in the Mayo Clinic Breast Clinic between August 1, 1993 and November 31, 2003. Breast cancer patients and noncancer patients significantly differed with respect to age at time of the index visit (p < 0.001), number of pregnancies (p = 0.006), number of live births (p = 0.002), vital status at last known follow-up (p < 0.001), current menstruation (p < 0.001), age at menopause (p < 0.001), history of hysterectomy (p < 0.001), use of oral contraception (p = 0.05), duration of oral contraception use (p = 0.001), use of other exogenous hormones (p < 0.001), duration of exogenous hormone use (p = 0.05), breast pain at time of index visit (p = 0.002), smoking status (p < 0.001), and use of five or more alcoholic beverages per week (p = 0.002). After adjustment for these baseline characteristics, having a personal history of smoking was found to be predictive of breast cancer diagnosis (odds ratios [OR] = 1.25, p = 0.004). Other positive predictors for breast cancer diagnosis were: age (OR = 1.02, p < 0.001), history of hysterectomy (OR = 0.66, p < 0.001), prior use of oral contraception for more than 11 years (OR = 2.10, p < 0.001), and prior use of other exogenous hormones/estrogen (OR = 1.81, p < 0.001). In this referral practice having a personal history of smoking is predictive of breast cancer diagnosis. Further studies are needed to further explore this relationship.
The Breast Journal 08/2009; 15(5):489-95. · 1.64 Impact Factor
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ABSTRACT: More than a decade has passed since the conclusion of the Minnesota tobacco trial and the signing of the Master Settlement Agreement (MSA) by 46 US State Attorneys General and the US tobacco industry. The Minnesota settlement exposed the tobacco industry's long history of deceptive marketing, advertising, and research and ultimately forced the industry to change its business practices. The provisions for public document disclosure that were included in the Minnesota settlement and the MSA have resulted in the release of approximately 70 million pages of documents and nearly 20,000 other media materials. No comparable dynamic, voluminous, and contemporaneous document archive exists. Only a few single events in the history of public health have had as dramatic an effect on tobacco control as the public release of the tobacco industry's previously secret internal documents. This review highlights the genesis of the release of these documents, the history of the document depositories created by the Minnesota settlement, the scientific and policy output based on the documents, and the use of the documents in furthering global public health strategies.
Mayo Clinic Proceedings 06/2009; 84(5):446-56. · 5.70 Impact Factor
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Kristin S Vickers,
Christi A Patten,
Beth A Lewis,
Matthew M Clark,
Michael Ussher,
Jon O Ebbert,
Ivana T Croghan,
Paul A Decker,
Julie Hathaway,
Bess H Marcus, Richard D Hurt
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ABSTRACT: Depressive symptoms negatively impact smoking abstinence. However, few interventions have been targeted to smokers with current depression. Exercise improves mood and may benefit depressed smokers. This pilot study investigated the feasibility of an exercise intervention for depressed female smokers (Center for Epidemiological Studies Depression Scale [CES-D] score > or =16).
Participants (M = 41 years, 98% White) were randomized to 10 weeks of individually delivered exercise counseling (n = 30) or a health education contact control condition (n = 30). All participants received nicotine patch therapy and behavioral counseling for smoking cessation.
The intervention was feasible as indicated by ability to recruit participants, exercise counseling session attendance (M = 7.6 of 10 sessions attended), and significant increase in exercise frequency and stage of change from baseline to end of treatment (EOT) (Week 10). Participant attrition rate was 35% by Week 10 but did not differ significantly between groups. Smoking abstinence rates at Week 10, using intention-to-treat analysis, were 17% for exercise counseling participants and 23% for health education participants (p = .75).
An exercise counseling intervention was found to be feasible for depressed women smokers. More intensive intervention may be needed to increase smoking abstinence rates, and methods should be refined to reduce participant burden and attrition.
Nicotine & Tobacco Research 06/2009; 11(8):985-95. · 2.58 Impact Factor
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ABSTRACT: A paucity of data exists regarding the safety and effectiveness of combination treatment with varenicline and nicotine replacement therapy (NRT).
We reviewed the clinical experience of two groups of cigarette smokers enrolled in a residential tobacco treatment program: (a) patients receiving combination treatment with varenicline and NRT (N = 104) and (b) usual-care patients receiving treatment before the release of varenicline (N = 135).
Demographic characteristics were similar between the two groups. Among smokers receiving varenicline and NRT, 71% used the nicotine patch with a mean dose of 32 mg/day (SD = 14) and 73% used at least two types of NRT. Adverse events were experienced by 39% (95% CI = 31%-49%) of patients receiving varenicline and NRT and by 59% (95% CI = 51%-67%) of usual-care patients during the residential program. A total of five patients (5%) discontinued varenicline due to adverse events, compared with one patient in the usual-care group. We did not observe a significant difference in the 30-day point prevalence smoking abstinence rate at 6 months between patients treated with varenicline and NRT (54%; 95% CI = 44%-64%) and usual-care patients (59%; 95% CI = 50%-66%).
Our findings suggest that combination therapy with varenicline and NRT is safe and well tolerated among patients in a residential tobacco treatment program.
Nicotine & Tobacco Research 05/2009; 11(5):572-6. · 2.58 Impact Factor
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ABSTRACT: Varenicline and bupropion sustained release (SR) are both safe and effective for the treatment of tobacco dependence and have different mechanisms of action. Combination pharmacotherapy with these agents may increase long-term smoking abstinence rates above what is observed with single-agent therapy.
We enrolled cigarettes smokers in an open-label, one-arm, Phase II clinical trial to obtain preliminary data on the potential effectiveness and safety of combination therapy with varenicline and bupropion SR for the treatment of tobacco dependence. Eligible subjects received varenicline titrated to 1.0 mg by mouth twice daily and bupropion SR titrated to 150 mg by mouth twice daily for a total of 12 weeks along with behavioral therapy. Self-reported smoking abstinence was biochemically confirmed with expired carbon monoxide. A total of 38 smokers with a mean age of 49.1 years (SD = 12.4) who smoked an average of 19.9 cigarettes/day (SD = 7.8) for 30 years (SD = 12.3) were enrolled.
Seven-day point-prevalent smoking abstinence rates were 71% (95% CI = 54%-85%) at 3 months and 58% (95% CI = 41%-74%) at 6 months. Mean weight change during the medication phase among smoking-abstinent subjects was 1.6 kg (SD = 2.4). For both medications, 74% of subjects took at least 90% of the prescribed doses. The most common side effects were sleep disturbance (26%) and nausea (24%). No increase in depressive symptoms was observed, and no subjects reported suicidal ideation.
Combination therapy with varenicline and bupropion SR may be effective for increasing smoking abstinence rates above that observed with monotherapy.
Nicotine & Tobacco Research 03/2009; 11(3):234-9. · 2.58 Impact Factor
