Michael V. Burke

Combination treatment with varenicline and nicotine replacement therapy

INTRODUCTION A paucity of data exists regarding the safety and effectiveness of combination treatment with varenicline and nicotine replacement therapy (NRT). METHODS 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). RESULTS 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%). DISCUSSION Our findings suggest that combination therapy with varenicline and NRT is safe and well tolerated among patients in a residential tobacco treatment program.

Treatment of Tobacco Dependence

Cigarette smoking continues to cause substantial death and disability, but more than 1 in 5 adults smoke despite the desire among most smokers to stop and the availability of effective treatments. A systematic process to identify all smokers is crucial. Because tobacco dependence is characterized by relapses and remissions, clinicians should be ready to engage smokers and reengage relapsed smokers with options for new medication strategies and additional counseling resources.

Residential Treatment Compared With Outpatient Treatment for Tobacco Use and Dependence

OBJECTIVE To compare the effectiveness of outpatient vs residential treatment for tobacco dependence in a large referral practice. PATIENTS AND METHODS 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. RESULTS 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). CONCLUSION 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.

Varenicline for smoking cessation: a narrative review of efficacy, adverse effects, use in at-risk populations, and adherence.

Treating tobacco dependence is the most effective way to reduce tobacco-related death and disability. Counseling and pharmacotherapy have been shown to increase tobacco abstinence rates among smokers. Varenicline is the most effective monotherapy treatment for tobacco dependence; however, it is prescribed less often than indicated, and adherence is less than optimal. We conducted a literature review of the development, efficacy, safety, contraindications, and adverse effects of varenicline; including reviewing data regarding combination therapy, extended duration, and patient adherence. Varenicline was developed to work specifically on the factors that underlie nicotine addiction. Phase II and Phase III trials established dosing, safety profiles, and efficacy. Postmarketing research raised concerns about neuropsychiatric and cardiac effects, resulting in warning labels being added and modified to encourage discussions with patients weighing the risks and benefits. While more research is needed, evidence is strong that varenicline is safe and effective in treating tobacco dependence among people who are at higher risk for neuropsychiatric symptoms and cardiovascular disease. The effectiveness of varenicline can be improved by taking it in combination with other medications, enhancing patient adherence and extending the duration of treatment.

Quitline Tobacco Interventions in Hospitalized Patients: A Randomized Trial.

INTRODUCTION Hospitalization provides an opportunity for smokers to quit, but tobacco interventions can require specialized services that are not available to many hospitals. This study tests the hypothesis that a brief intervention to facilitate the use of telephone quitline services for both initial and follow-up counseling is effective in helping patients achieve sustained abstinence. DESIGN This was a population-based RCT. SETTING Participants were Olmsted County, MN residents who reported current smoking and were admitted to Mayo Clinic hospitals in Rochester, MN between May 2012 and August 2014. INTERVENTION A control group received brief (~5-minute) cessation advice; an intervention group received a brief (~5-minute) quitline facilitation intervention, with either warm handoff or faxed referral to a national quitline provider. All were offered a 2-week supply of nicotine patches at discharge. MAIN OUTCOME MEASURES Outcomes included self-reported 7-day point prevalence abstinence at 6 months after hospitalization and quitline utilization. Data analysis was performed from September 2014 to March 2015. RESULTS Of the 1,409 eligible patients who were approached, 600 (47%) were randomized. The quitline intake call was completed by 195 subjects (65% of the intervention group). Of these, 128 (66%) completed the first coaching call. Self-reported abstinence rates at 6 months after discharge were identical in both groups (24%). CONCLUSIONS The quitline facilitation intervention did not improve self-reported abstinence rates compared with a standard brief stop-smoking intervention. These results do not support the effectiveness of quitlines in providing tobacco use interventions to a general population of hospitalized smokers.

Clinical utility of varenicline for smokers with medical and psychiatric comorbidity

Chronic obstructive pulmonary disease (COPD) is a costly and deadly disease afflicting an estimated 210 million people and accounting for 5% of all global deaths. Exposure to cigarette smoke is the greatest risk factor for COPD in the developed world. Smoking cessation improves respiratory symptoms and lung function and reduces mortality among patients with COPD. Cigarette smokers with COPD and other co-morbid conditions such as cardiovascular disease and psychiatric illnesses should receive comprehensive tobacco treatment interventions incorporating efficacious pharmacotherapies. Varenicline, an α4β2 nicotinic acetylcholine receptor partial agonist, is the newest and most effective drug currently available to promote smoking cessation. In conjunction with behavioral interventions and clinical monitoring for potential side effects, varenicline offers great hope for reducing smoking-attributable death and disability.

Treatment Outcomes From a Specialist Model for Treating Tobacco Use Disorder in a Medical Center

AbstractCigarette smoking causes premature mortality and multiple morbidity; stop smoking improves health. Higher rates of smoking cessation can be achieved through more intensive treatment, consisting of medication and extended counseling of patients, but there are challenges to integrating these interventions into healthcare delivery systems. A care model using a master-level counselor trained as a tobacco treatment specialist (TTS) to deliver behavioral intervention, teamed with a supervising physician/prescriber, affords an opportunity to integrate more intensive tobacco dependence treatment into hospitals, clinics, and other medical systems. This article analyzes treatment outcomes and predictors of abstinence for cigarette smokers being treated using the TTS-physician team in a large outpatient clinic over a 7-year period.This is an observational study of a large cohort of cigarette smokers treated for tobacco dependence at a medical center. Patients referred by the primary healthcare team for a TTS consult received a standard assessment and personalized treatment planning guided by a workbook. Medication and behavioral plans were developed collaboratively with each patient. Six months after the initial assessment, a telephone call was made to ascertain a 7-day period of self-reported abstinence. The univariate association of each baseline patient characteristic with self-reported tobacco abstinence at 6 months was evaluated using the chi-squared test. In addition, a multiple logistic regression analysis was performed with self-reported tobacco abstinence as the dependent variable and all baseline characteristics included as explanatory variables.Over a period of 7 years (2005–2011), 6824 cigarette smokers who provided general research authorization were seen for treatment. The 6-month self-reported abstinence rate was 28.1% (95% confidence interval: 27.7–30.1). The patients most likely to report abstinence were less dependent, more motivated to quit, and did not have a past year diagnosis of depression or alcoholism.Predictable patient characteristics such as level of dependence did predict abstinence, but all patient groups achieved comparable abstinence outcomes. While this study has limitations inherent in a single-center retrospective cohort study, it does suggest that the TTS model is an effective way to integrate more intensive tobacco dependence treatment into outpatient settings.

Two case reports of severe myocarditis associated with the initiation of dolutegravir treatment in HIV patients.

Rationale:The integrase inhibitor dolutegravir is now recommended as first-line treatment for HIV. A single case of myocarditis after treatment with dolutegravir was reported in the FLAMINGO trial. We present here 2 cases of severe myocarditis that occurred shortly after the initiation of dolutegravir treatment. Patients concerns:The first case is a 45-year-old female who developed severe congestive heart failure and died, weeks after the initiation of dolutegravir treatment (for simplification of her antiretroviral regimen). The second case was a 51-year-old male who presented with effort dyspnea 3 weeks after the initiation of dolutegravir treatment and was later diagnosed as severe congestive heart failure. The treatment was changed and the patient survived, but he still suffers from severe heart failure with functional impairment. Diagnosis and Outcome:Patient 1 died, patient 2 suffers from severe heart failure. Lessons:We discuss here the possible relationship between the initiation of dolutegravir treatment and the development of lymphocytic myocarditis in our patients, and we suggest a possible mechanism.

A Narrative Review of Intensive Group Tobacco Treatment: Clinical, Research, and US Policy Recommendations

Introduction Clinical practice guidelines recommend comprehensive treatment for tobacco dependence including pharmacotherapies and behavioral interventions. Group counseling may deliver unique treatment aspects not available with other modalities. This manuscript provides a narrative review of group treatment outcomes from real world practice settings and complements recent meta-analyses of randomized controlled trials (RCTs). Our primary goals were to determine whether group treatments delivered in these settings have yielded similar quit rates compared to individual treatment and to provide recommendations for best practices and policy. Methods Group treatment was defined as occurring in a clinical or workplace setting (i.e., not provided as part of a research study), led by a professionally trained clinician, and offered weekly over several weeks. English language PubMed articles from January 2000-July 2017 were searched to identify studies that included outcomes from both group and individual treatment offered in real world settings. Additional data sources meeting our criteria were also included. Reports not using pharmacotherapy and research studies (e.g., RCTs) were excluded. The primary outcome was short-term, CO-validated point prevalence abstinence (4-weeks post-quit date). Results The review included data from 11 observational studies. In all cases, group treatment(s) had higher 4-week CO-validated quit rates (range 35.5-67.3%) than individual treatment(s) (range 18.6%-53.3%). Conclusions Best practice group treatments for tobacco dependence are generalizable from research to clinical settings and likely to be at least as effective as intensive individual treatment. The added advantages of efficiency and cost-effectiveness can be significant. Group treatment is feasible in various settings with good results. Implications A major barrier to achieving high rates of tobacco abstinence is under-utilization of evidence-based treatment interventions. This review demonstrates the effectiveness and utility of group treatment for tobacco dependence. Based on the available data described in this narrative review in conjunction with existing RCT data, group treatment for tobacco dependence should be established and available in all behavioral health and medical settings. Group tobacco treatment is now one of the mandated reimbursable tobacco treatment formats within the US healthcare system, creating enormous opportunities for widespread clinical reach. Finally, comprehensive worksite group programs can further extend impact.