Flexible, dual-form nicotine replacement therapy or varenicline in comparison with nicotine patch for smoking cessation: a randomized controlled trial.

BACKGROUND: Extended use of combined pharmacotherapies to treat tobacco dependence may increase smoking abstinence; few studies have examined their effectiveness. The objective of this study was to evaluate smoking abstinence with standard nicotine patch (NRT), extended use of combined formulations of nicotine replacement therapy (NRT+), or varenicline (VR). METHODS: A total of 737 smokers, including those with medical and psychiatric comorbidities, were randomly assigned to one of the above three treatment conditions. The NRT group received 10 weeks of patches (21 mg daily maximum); the NRT+ group received patches (35 mg daily maximum) and gum or inhaler for up to 22 weeks; and the VR group received 1 mg twice daily for up to 24 weeks (22 weeks post target quit date). All participants also received six standardized 15-minute smoking cessation counseling sessions by nurses experienced in tobacco dependence treatment. The primary outcome was carbon monoxide-confirmed continuous abstinence rates (CAR) from weeks 5-52. Secondary outcomes were: CAR from weeks 5-10 and 5-22, and carbon monoxide-confirmed 7-day point prevalence (7PP) at weeks 10, 22, and 52. Adjusted and unadjusted logistic regression analyses were conducted using intention-to-treat procedures. RESULTS: The CARs for weeks 5-52 were 10.0 %, 12.4 %, and 15.3 % in the NRT, NRT+, and VR groups, respectively; no group differences were observed. Results with 7PP showed that VR was superior to NRT at week 52 (odds ratio (OR), 1.84; 97.5 % Confidence Interval (CI), 1.04-3.26) in the adjusted intention-to-treat analysis. Those in the VR group had higher CAR at weeks 5-22 (OR, 2.01; CI, 1.20-3.36) than those in the NRT group. Results with 7PP revealed that both NRT+ (OR, 1.72; CI, 1.04-2.85) and VR (OR, 1.96; CI, 1.20-3.23) were more effective than NRT at 22 weeks. As compared to NRT monotherapy, NRT+ and VR produced significant increases in CAR for weeks 5-10 (OR, 1.52; CI, 1.00-2.30 and OR, 1.58; CI, 1.04-2.39, respectively); results were similar, but somewhat stronger, when 7PP was used at 10 weeks (OR, 1.57; CI, 1.03-2.41 and OR, 1.79; CI, 1.17-2.73, respectively). All medications were well tolerated, but participants in the VR group experienced more fatigue, digestive symptoms (e.g., nausea, diarrhea), and sleep-related concerns (e.g., abnormal dreams, insomnia), but less dermatologic symptoms than those in the NRT or NRT+ groups. The frequency of serious adverse events did not differ between groups. CONCLUSIONS: Flexible and combination NRT and varenicline enhance success in the early phases of quitting. Varenicline improves abstinence in the medium term; however, there is no clear evidence that either varenicline or flexible, dual-form NRT increase quit rates in the long-term when compared to NRT monotherapy. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01623505 ; Retrospectively registered on July 13, 2011.

Learning a new way of living together: a qualitative study exploring the relationship changes and intervention needs of patients with cardiovascular disease and their partners.

OBJECTIVES: Cardiovascular disease (CVD) not only affects the patient, but has implications for the partner. Emerging evidence suggests that supportive couple relationships enhance CVD outcomes and reduce patient and partner distress. To date, however, little research has been done to address the couple relationship as a potentially important component of cardiac care. This article examines the impact of CVD on the couple relationship and assesses the perceived needs and desired intervention components of patients with CVD and their partners. DESIGN: Qualitative study using directed and conventional content analysis. SETTING: Single-centre, tertiary cardiac care hospital that serves a population of 1.4 million in the Champlain region of Ontario, Canada. PARTICIPANTS: Patients with CVD and their partners (n=32, 16 couples) participated in focus groups. Patients were mainly male (75%), white (87.5%), aged 64.4 years (range 31-81 years), with varied cardiac diagnoses (50% coronary artery disease; 18.75% valve disease; 18.75% heart failure; 12.5% arrhythmia). RESULTS: Five categories were generated from the data reflecting changes within the couple relationship as a result of CVD: (1) emotional and communication disconnection; (2) overprotection of the patient; (3) role changes; (4) adjustment to lifestyle changes; and (5) positive relationship changes. Three categories were constructed regarding intervention needs and desired resources: (1) practical resources; (2) sharing with peers; and (3) relationship enhancement. CONCLUSIONS: Overall, the data suggest that there were profound changes in the couple relationship as a result of CVD, and that there is considerable need to better support the caregiving spouses and the couple as a unit. These results call for interventions designed to provide instrumental support, peer-sharing opportunities and relationship quality enhancement to help couples cope with CVD. Future studies should examine whether couples-based programming embedded into cardiac rehabilitation can be effective at improving relationship quality and reducing patient and partner stress in the aftermath of a cardiac event.

The Quit Experience and Concerns of Smokers With Psychiatric Illness.

INTRODUCTION: The purpose of this study is to better understand the quit experience and concerns of smokers with psychiatric illness (i.e., major depressive, anxiety, psychotic and bipolar disorders) in comparison with those without psychiatric illness. METHODS: Smokers (N=732) with (n=430, 59%) and without psychiatric illness, recruited between June 2010 and March 2013 to participate in the FLEX (Flexible and Extended Dosing of Nicotine Replacement Therapy [NRT] and Varenicline in Comparison to Fixed-Dose NRT for Smoking Cessation) smoking-cessation trial, completed questionnaires assessing previously used cessation aids and reasons for relapse, and motivation and concerns about their upcoming quit attempt. These supplementary data analyses were conducted in May 2015. RESULTS: The most commonly used cessation methods during previous attempts were nicotine replacement therapy (66.4%), cold turkey (59.7%), and bupropion (34.7%); no group differences were identified. Stress was the most common precipitator of relapse during previous attempts in all groups (43.6%), particularly among participants with depression and anxiety. Health was the most common motivation for the upcoming quit attempt (91%), followed by family/social pressures (28.1%) and cost (27.9%, particularly by smokers with psychotic disorders). Common pre-cessation concerns for the complete sample included: cravings (27.6%), stress (26.7%), and fear of failure (26%); participants with psychotic and anxiety disorders were most concerned about cravings, whereas the latter two concerns were more prominent for individuals with anxiety. CONCLUSIONS: Findings reveal differences in the quit histories and concerns of smokers with or without psychiatric illness. Smokers with psychiatric illness are particularly vulnerable to relapse at times of stress and negative affect; interventions that emphasize alternative coping strategies and facilitate mood management are required.