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      Placebo-Controlled Trial of Cytisine for Smoking Cessation

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          Abstract

          Cytisine, a partial agonist that binds with high affinity to the α(4)β(2) nicotinic acetylcholine receptor, is a low-cost treatment that may be effective in aiding smoking cessation. This study assessed the efficacy and safety of cytisine as compared with placebo. We conducted a single-center, randomized, double-blind, placebo-controlled trial. Participants were randomly assigned to receive cytisine or matching placebo for 25 days; participants in both groups received a minimal amount of counseling during the study. The primary outcome measure was sustained, biochemically verified smoking abstinence for 12 months after the end of treatment. Of 1542 adult smokers screened, 740 were enrolled and 370 were randomly assigned to each study group. The rate of sustained 12-month abstinence was 8.4% (31 participants) in the cytisine group as compared with 2.4% (9 participants) in the placebo group (difference, 6.0 percentage points; 95% confidence interval [CI], 2.7 to 9.2; P=0.001). The 7-day point prevalence for abstinence at the 12-month follow-up was 13.2% in the cytisine group versus 7.3% in the placebo group (P=0.01). Gastrointestinal adverse events were reported more frequently in the cytisine group (difference, 5.7 percentage points; 95% CI, 1.2 to 10.2). In this single-center study, cytisine was more effective than placebo for smoking cessation. The lower price of cytisine as compared with that of other pharmacotherapies for smoking cessation may make it an affordable treatment to advance smoking cessation globally.

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          Assessment of Depression: The Depression Inventory

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            A comparison of the Fagerström Test for Nicotine Dependence and smoking prevalence across countries.

            To examine the correlation between the Fagerström Test for Nicotine Dependence (FTND) score and smoking prevalence across countries. Cross-sectional study. Fifteen studies from 13 countries with FTND score data. Samples of smokers were identified through systematic literature searches, web queries and colleagues. Smokers were considered representative of their country's smoking population if they were drawn from population-based sources, were not seeking smoking cessation treatment and did not have significant comorbidities. Smoking prevalence data were derived from the study itself or the country's population rate of daily smoking for the study year. A Pearson correlation coefficient was used to examine the direction and magnitude of the correlation between FTND score and smoking prevalence across countries. FTND scores ranged from 2.8 to 4.6. Smokers in Germany and Norway had the lowest FTND scores, while smokers in Sweden and the United States had the highest FTND scores. The prevalence of daily smoking in these countries was very different: 37% and 30% in Germany and Norway, 19% and 16% in the United States and Sweden, respectively. An inverse correlation towards higher FTND scores in countries with lower smoking prevalence was found (r=-0.73, P=0.001). Current smokers had higher FTND scores than former smokers. The significant inverse correlation between FTND score and smoking prevalence across countries and higher FTND score among current smokers supports the idea that remaining smokers may be hardening. Less dependent smokers may quit more easily and remaining dependent smokers may need more intensive treatment.
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              Varenicline and suicidal behaviour: a cohort study based on data from the General Practice Research Database

              Objective To determine whether varenicline, a recently licensed smoking cessation product, is associated with an increased risk of suicide and suicidal behaviour compared with alternative treatments bupropion and nicotine replacement therapy. Design Cohort study nested within the General Practice Research Database. Setting Primary care in the United Kingdom. Participants 80 660 men and women aged 18-95 years were prescribed a new course of a smoking cessation product between 1 September 2006 and 31 May 2008; the initial drugs prescribed during follow-up were nicotine replacement products (n=63 265), varenicline (n=10 973), and bupropion (n=6422). Main outcome measures Primary outcomes were fatal and non-fatal self harm, secondary outcomes were suicidal thoughts and depression, all investigated with Cox’s proportional hazards models. Results There was no clear evidence that varenicline was associated with an increased risk of fatal (n=2) or non-fatal (n=166) self harm, although a twofold increased risk cannot be ruled out on the basis of the upper limit of the 95% confidence interval. Compared with nicotine replacement products, the hazard ratio for self harm among people prescribed varenicline was 1.12 (95% CI 0.67 to 1.88), and it was 1.17 (0.59 to 2.32) for people prescribed bupropion. There was no evidence that varenicline was associated with an increased risk of depression (n=2244) (hazard ratio 0.88 (0.77 to1.00)) or suicidal thoughts (n=37) (1.43 (0.53 to 3.85)). Conclusion Although a twofold increased risk of self harm with varenicline cannot be ruled out, these findings provide some reassurance concerning its association with suicidal behaviour.
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                Author and article information

                Journal
                New England Journal of Medicine
                N Engl J Med
                Massachusetts Medical Society
                0028-4793
                1533-4406
                September 29 2011
                September 29 2011
                : 365
                : 13
                : 1193-1200
                Article
                10.1056/NEJMoa1102035
                21991893
                31954721-56ed-4b95-8714-374f04309b51
                © 2011
                History

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