Combining varenicline and nicotine patches: a randomized controlled trial study in smoking cessation.

BACKGROUND: Some smokers may benefit from a therapy that combines different nicotine replacement therapies (NRT) or drugs with different mechanisms of action.The aim of this study was to determine the efficacy of the combined therapy of varenicline and nicotine patches versus varenicline monotherapy. METHODS: Three hundred forty-one smokers who smoked 20 or more cigarettes per day were recruited from a smoking cessation clinic between February 2012 and June 2013. The participants were randomized to receive a varenicline plus nicotine patch of 21 mg every 24 hours (170) or varenicline plus a placebo patch (171). All of the smokers received a standard 12-week course of varenicline and an 11-week course of either the placebo patch or the active patch after the target quit day. Both groups received behavioral support. The primary outcome was continuous abstinence for weeks 2 through 12 confirmed by exhaled levels of carbon monoxide. Post hoc subgroup analyses were performed to evaluate the treatment effects for a specific endpoint in subgroups of smokers. RESULTS: The combination of the nicotine patch with varenicline was not associated with higher rates of continuous abstinence at 12 weeks (39.1% versus 31.8%; odds ratio (OR) 1.24; 95% confidence interval (CI) 0.8 to 2.6) and 24 weeks (32.8% versus 28.2%; OR 1.17; 95% CI 0.4 to 1.9). When participants were analyzed by subgroups according to cigarette consumption, the abstinence rates among smokers who smoked more than 29 cigarettes per day at 12 weeks (OR 1.39; 95% CI 1.2 to 2.5) and 24 weeks (OR 1.46; 95% CI 1.2 to 2.8) were significantly higher in the combination group. Other post hoc analyses based on level of dependence and previous quit attempts did not show subgroup differences. No differences between the groups for the reported adverse events were observed (χ2 value 0.07; P 0.79). CONCLUSIONS: The combination of varenicline with the nicotine patch does not improve abstinence rates at 12 and 24 weeks compared with varenicline used as monotherapy when all smokers were analyzed as a whole, independent of consumption level. TRIAL REGISTRATION: This study is registered at clinicaltrial.gov (NCT01538394).

A multicentre randomized trial of combined individual and telephone counselling for smoking cessation.

OBJECTIVE: The present study assessed the effectiveness of smoking cessation programs combining individual and telephone counselling, compared to individual or telephone counselling alone. METHOD: A randomized, multicentre, open-label trial was performed between January 2009 and July 2011 at six smoking cessation clinics in Spain. Of 772 smokers assessed for eligibility, 600 (77%) met inclusion criteria and were randomized. Smokers were randomized to receive individual counselling, combined telephone and individual counselling, or telephone counselling. The primary outcome was biochemically validated continuous abstinence at 52 weeks. RESULTS: The 52-week abstinence rate was significantly lower in the telephone group compared to the combined group (20.1% vs. 29.0%; OR, 1.32; 95% CI, 1.1-2.7) and to the individual counselling group (20.1% vs. 27.9%; OR, 1.37; 95% CI, 1.0-2.8). The 52-week abstinence rates were not significantly higher in the combined group than the individual group (OR, 0.97; 95% CI, 0.7-1.4). CONCLUSION: Individual counselling and combined individual and telephone counselling were associated with higher 52-week abstinence rates than telephone counselling alone. A combined approach may be highly useful in the clinical treatment of smokers, as it involves less clinic visits than individual counselling alone, thus reducing the program cost, and it increases patient compliance compared to telephone counselling alone.

Gambling disorder seeking treatment patients and tobacco use in relation to clinical profiles.

OBJECTIVES: Tobacco smoking and gambling disorder (GD) often co-occur. However, few studies have assessed the extent to which cigarette smoking may serve to classify and/or better define GD behaviour profiles. METHODS: Among a large sample of n = 3,652 consecutive treatment-seeking patients with GD (91% men). Smokers were compared to non-smokers across different sociodemographic, clinical, psychopathological and personality variables. The effect sizes for the means and the proportion differences between the groups were estimated. An evaluation of the smoking changes over the last 15 years was also performed. RESULTS: From the total sample, 62.4% of gamblers reported tobacco use. A decreasing linear trend in tobacco use was observed within the studied period, women having a more irregular pattern. The use of tobacco was linked to the use of alcohol and other illegal drugs. Gamblers who smoke, as compared to those who don't, presented lower education levels, lower social position indexes and active employment. They were younger, with an earlier age of onset, shorter duration of the gambling behavior, higher GD severity, more psychological symptoms, higher scores in novelty seeking and lower scores in reward dependence, self-directedness and self-transcendence. CONCLUSIONS: Gamblers seeking treatment who smoke display particular social, clinical, psychological, temperamental and character features different from non-smoking gamblers, suggesting that the presence or absence of comorbid smoking condition in GD should always be considered when developing an optimal treatment, as gamblers who smoke might need treatment strategies different from non-smoking gamblers.

Blood-borne tissue factor activity predicts major cerebrovascular events in patients undergoing carotid endarterectomy: results from a 1-year follow-up study.

BACKGROUND: Tissue factor (TF) expression is increased in inflammatory atherosclerotic plaques and has been related to plaque thrombogenicity. Blood-borne TF activity seems to contribute to a procoagulant state in patients with vascular risk factors. The aim of this study was to assess whether the expression of TF in carotid plaques from patients undergoing carotid endarterectomy (CEA) or/and blood-borne ('circulating') TF activity could predict future vascular complications. METHODS: A total of 105 consecutive patients (85 male and 20 female aged 61-77 years)undergoing CEA for high-grade internal carotid artery were included in the study. Carotid artery specimens were classified into active (n = 52; rich in inflammatory cells) and nonactive plaques (n = 53; poor in inflammatory cells or fibrous). TF mRNA levels in carotid plaques were assessed by real-time PCR (TaqMan Low-Density Arrays) and TF protein levels by Western blot. Blood-borne TF activity and other biochemical parameters, including low-density lipoprotein cholesterol (LDLc) levels and high-sensitivity C-reactive protein, were measured prior to surgery. Patients were followed up for 1 year and vascular and nonvascular complications were scored. RESULTS: TF expression was higher in active CEA plaques. Patients with active CEA plaques exhibited higher plasma LDLc levels (3.6 +/- 0.7 vs. 2.1 +/- 1 mM, p < 0.05) that positively correlated with plaque TF mRNA levels (p = 0.0125; r = 0.9). Blood-borne TF activity did not correlate with plasma LDLc levels and was unrelated to the anatomo-pathological characteristic of the CEA plaques (thrombosis, rupture, inflammation, lipid core, necrosis or calcification). Circulating TF activity predicted vascular complications at 1 year, including fatal (OR, 1.18; 95% CI, 0.6-2.2, p < 0.01) and nonfatal ischemic stroke (OR, 1.22; 95% CI, 0.5-2.0, p < 0.05) and symptomatic peripheral vascular disease (OR, 1.48; 95% CI, 0.4-2.6, p < 0.005). CONCLUSIONS: Blood-borne TF activity prior to CEA but not local TF expression or plasma LDLc levels predict cerebrovascular and peripheral vascular disease events at 1 year in elderly patients subjected to CEA for high-grade carotid stenosis.

Prognostic factors for tobacco consumption reduction after relapse.

INTRODUCTION: It is not properly estimated the cigarette consumption after a relapse compared with the consumption before a smoking cessation therapy. The aim of this study was to know if tobacco consumption among relapsed smokers that visited a smoking cessation unit is higher or lower than consumption preceding dishabituation therapy and the related factors to this consumption change. SUBJECTS AND METHODS: 1,516 smokers who received a multicomponent program for smoking cessation have been studied. The percentage of reduction after the relapse in relation to previous consumption and the consumption difference with regard to basal variables among 994 relapsed smokers has been calculated. A logistic regression model was used in order to analyze the predictors to reduce more than 50% of previous cigarette consumption. RESULTS: Relapsed patients smoked 20.4% less than before the smoking cessation therapy. Smokers with chronic obstructive pulmonary disease, and with the age of 50 years or more, had the highest rate of reduction consumption. The best predictors for cigarette reduction were those of low nicotine dependence and being heavy smokers. CONCLUSIONS: Heavy smokers or low nicotine dependence smokers have a higher probability to reduce their cigarette consumption. Other predictor variables are age of more than 50 years, high previous consumption or previous abstinence period of more than 6 months.

Effects of partner smoking status and gender on long term abstinence rates of patients receiving smoking cessation treatment.

AIMS: To assess the effect of partner smoking status on the success of a cessation program. DESIGN: Prospective cohort. SETTING: Smoking Cessation Unit in Hospital of Bellvitge (Hospitalet de Llobregat, Barcelona). PARTICIPANTS: A total of 1516 smokers of 10 or more cigarettes who started a smoking cessation program between January 1995 and December 2001 were included. MEASUREMENTS: All patients gave information about smoking history and smoking partner status. Abstinence was determined by carbon monoxide exhaled. FINDINGS: Significant differences were found in the abstinence rates at 12 months by smoking partner status: abstinence was achieved by 28.3% of patients with smoking partner, and by 46.5% of patients without smoking partner (p<0.001). Subjects whose partner was smoking at the beginning of the program appear to be more likely to relapse than subjects without smoking partners (p<0.001) and this is more pronounced in women than in men. However no significant gender differences were found in any group of smoking partner status. CONCLUSIONS: Having a smoking partner is a determinant of relapse 1 year after the beginning of the cessation program. Interacting not just with the smoker, but also with his or her partner, could neutralize interpersonal influences making smokers more accessible to behavioural and pharmacological techniques.

Sentinel lymph node identification and radical hysterectomy with lymphadenectomy in early stage cervical cancer: laparoscopy versus laparotomy.

STUDY OBJECTIVE: To estimate the feasibility and results of sentinel lymph node identification and radical hysterectomy with pelvic lymphadenectomy entirely completed by laparoscopy versus laparotomy in early stage cervical cancer. DESIGN: Retrospective, nonrandomized clinical study (Canadian Task Force classification II-2). SETTING: Acute care, teaching hospital. PATIENTS: From September 2000 through January 2005, 50 consecutive patients with International Federation of Gynecology and Obstetrics stage IA2, IB1, and IIA disease less than 4 cm underwent radical hysterectomy and lymphadenectomy with intraoperative sentinel lymph node biopsy. INTERVENTIONS: The operation was performed entirely by laparoscopy in 20 patients and using the conventional abdominal approach in 30. Feasibility of sentinel lymph node identification, surgical morbidity, overall survival, and recurrence rate-free survival in both groups were compared. MEASUREMENTS AND MAIN RESULTS: The overall detection rate of the sentinel lymph node was 100% (false negative 0%). A mean of 2.50 sentinel nodes/patient was detected in the laparotomy group compared with a mean of 2.55 nodes in the laparoscopic group (p=.874). Bifurcation of the right common iliac artery was the most frequent nodal location. Blood loss and length of stay were significantly lower in the laparoscopic group, but surgical time was significantly longer. The median follow-up was 35 months (range 5-57) in the laparotomy group and 22.5 (range 2-52) in the laparoscopic group. Differences in overall survival and disease-free survival were not observed. CONCLUSION: Sentinel lymph node identification and radical hysterectomy in the initial treatment of early stage cervical cancer can be performed safely by laparoscopy with lower morbidity and overall survival and recurrence-free survival similar to standard laparotomy.

D-dimer local expression is increased in symptomatic patients undergoing carotid endarterectomy.

BACKGROUND: Although atherosclerosis is a silent widespread disease, the focal character of the lesions triggering the clinical manifestations is unquestionable. We hypothesized that symptomatic patients with advanced, unstable carotid plaques have increased local intraplaque and circulating levels of fibrin-fibrinogen related products. METHODS: Plaque tissue and plasma samples were studied in 106 patients undergoing endarterectomy for symptomatic and asymptomatic carotid disease. Fibrin-fibrinogen related products were evaluated by ELISA, Western-blotting, and histology. All tested parameters were compared with patient carotid symptomatology, multiple vascular risk factors (VRF), bilateral carotid pathology, ultrasound examination, and previous therapies with statins and/or antiplatelet drugs. RESULTS: In symptomatic patients, plasma D-dimer was elevated in patients with unstable carotid plaques (UNS) compared with stable (STA) ones (857+/-121 vs. 692+/-156 ng/ml, p=0. 026). Furthermore, plasma D-dimer was significantly increased in patients with a coexistence of carotid and coronary artery disease, compared to others (976+/-325 vs. 714+/-197 ng/ml; p<0.001). Intra-plaque D-dimer content was increased in ulcerated-complicated (UC) plaques compared with fibrous non-complicated (F) plaques in symptomatic patients (5.9+/-1 vs. 1.8+/-1, p<0.001), and in patients with hypercholesterolaemia, compared with those with normal cholesterol levels (6.1+/-1 vs. 2.9+/-0.7; p=0.027). However, there was no correlation between D-dimer content in the carotid plaque and plasma D-dimer levels. CONCLUSIONS: Hypercholesterolemia and UC plaques appear to be associated with high fibrin intraplaque turnover as demonstrated by higher intraplaque D-dimer. Plasma markers of fibrin turnover were increased in UNS plaques, and in patients with coexisting carotid and coronary artery disease. Although, both plasma and plaque D-dimers were associated with unstable carotid disease, the usefulness of the measurement of plasma D-dimer in these patients should be confirmed by prospective studies.

Analysis of survival after laparoscopic-assisted vaginal hysterectomy compared with the conventional abdominal approach for early-stage endometrial carcinoma: a review of the literature.

STUDY OBJECTIVE: To assess potential differences in perioperative features and survival between laparoscopic-assisted vaginal hysterectomy and conventional transabdominal hysterectomy in stage I endometrial cancer. DESIGN: Retrospective, nonrandomized clinical study (Canadian Task Force classification II-2). SETTING: Acute-care, teaching hospital. PATIENTS: A total of 370 patients undergoing hysterectomy and bilateral salpingo-oophorectomy with surgical staging for primary treatment for clinical stage I endometrial cancer from January 1995 through June 2001. INTERVENTION: Clinical outcomes and survival in patients treated with laparoscopic-assisted vaginal hysterectomy (n = 55) and hysterectomy using the conventional abdominal approach (n = 315) were compared. MEASUREMENTS AND MAIN RESULTS: Baseline characteristics and histopathologic variables were similar in both groups. A total of 91.4% of patients underwent pelvic lymphadenectomy and 49.7% paraaortic lymphadenectomy. The median follow-up was 38.1 months. Blood loss, blood transfusions required, and length of stay were significantly lower in the laparoscopic group, but surgical time was significantly longer. The mean number of pelvic and aortic nodes recovered was higher in the laparoscopic group (p < .001). Differences in overall and recurrence-free survival rates were not observed. CONCLUSION: Surgical staging of early-stage endometrial cancer by laparoscopic-assisted vaginal hysterectomy is feasible, with lower perioperative morbidity and shorter hospital stay compared with transabdominal hysterectomy. Prognosis and survival were not affected by the laparoscopic vaginal approach to hysterectomy.

Efectividad de una intervención de deshabituación tabáquica en pacientes con patología cardiovascular / Effectiveness of Smoking Cessation Intervention in Patients with Cardiovascular Disease

Introducción y objetivos. La incidencia de acontecimientos coronarios desciende rápidamente en los pacientes con enfermedad cardíaca que dejan de fumar. Sólo un 50 por ciento de los pacientes que dejan el consumo de tabaco tras un episodio agudo permanecerán abstinentes a los 3 meses del alta hospitalaria. El objetivo del estudio es evaluar la efectividad de un programa de deshabituación tabáquica en pacientes con enfermedad cardiovascular. Métodos. Se estudió una cohorte de fumadores que iniciaron tratamiento deshabituador entre septiembre de 1993 y junio de 1999. Se compararon 348 pacientes con enfermedad cardiovascular con 1.107 sin ningún proceso patológico. Se realizó un seguimiento según el protocolo de 12 meses de duración y se determinó el monóxido de carbono exhalado en cada control para valorar la recaída. Se calculó la abstinencia en cada período y se estimaron las odds ratio para la recaída a los 12 meses. Resultados. Se observó una abstinencia continuada global a los 12 meses del 37,1 por ciento (129/348) entre los enfermos con enfermedad cardiovascular y del 39,6 por ciento (438/1.107) entre los pacientes sin ningún proceso patológico. Los fumadores consonantes (precontemplativos) presentaron un mayor número de recaídas, con una Odds ratio ajustada de 1,36. Conclusiones. En los pacientes con enfermedad cardiovascular de nuestra serie que no pudieron dejar el hábito tabáquico durante su ingreso o después de su diagnóstico, un tratamiento y seguimientos exhaustivos consiguió un porcentaje de abstinencia considerable, por lo que creemos que estos pacientes pueden beneficiarse de las unidades de deshabituación tabáquica (AU)