012012 v156 i2 cytisine increased smoking cessation in adults
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Cytisine, a partial nicotine receptor agonist, increased smoking cessation rates more than placebo in a randomized controlled trial of 740 adult smokers in Poland. Participants received a 25-day tapering course of cytisine or placebo along with minimal behavioral counseling. At 6-month and 12-month follow-ups, cytisine led to higher rates of smoking abstinence compared to placebo, with numbers needed to treat of 16 to 17. Cytisine was associated with more gastrointestinal side effects than placebo. While promising, further studies are still needed to confirm the findings, assess safety, and determine optimal dosing and cost-effectiveness before cytisine can be recommended for smoking cessation.
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012012 v156 i2 cytisine increased smoking cessation in adults
- 1. CopìaautorizadaporCDR Cytisine increased smoking cessation in adults West R, Zatonski W, Cedzynska M, et al. Placebo-controlled trial of cytisine for smoking cessation. N Engl J Med. 2011;365:1193-200. Source of funding: UK National Prevention Research Initiative. For correspondence: Dr. R. West, University College London, London, England, UK. E-mail robert.west@ucl.ac.uk. Dr. W. Zatonski, Cancer Center and Institute of Oncology, Warsaw, Poland. I Commentary Pharmacologic therapy and counseling for smoking cessation have been shown to improve nicotine abstinence rates in several ran- domized trials (1).The duration and frequency of counseling visits are strongly correlated with success, and counseling and medica- tion used together are more effective than either treatment alone (2). Current recommendations support a dual approach (2). Available pharmacologic agents include nicotine replacement (transdermal, inhaled, gum, lozenges, or nasal spray), antidepressants (bupropion and nortriptyline), and nicotine-receptor partial agonists, such as varenicline and cytisine. Varenicline doubles the abstinence rate compared with placebo but can cause nausea and other gastroin- testinal symptoms and may increase risk for cardiovascular events (3-5). Cytisine, another partial nicotine agonist, was studied in 1 other randomized trial in 1971 (3), is low cost, and has been used for many years in Eastern Europe. In the trial by West and colleagues, cytisine showed promise for increasing medium- and long-term abstinence rates. Although methodologically sound, it was a single-center study in Poland, and the generalizability of the findings is unknown.The study used minimal counseling, which was intended to reflect feasibility of implementation in resource-limited areas.The drug regimen required tapering from an initial dose of 1 tablet 6 times/d, which may be a barrier to adherence.This drug is not yet available in the USA, and it is not known whether it would be marketed at low cost as in Eastern Europe. An effective and inexpensive pharma- cologic option to augment currently available tools for smoking cessation would be of great benefit to patients and clinicians. Further trials of cytisine are needed to confirm the findings, assess harms, assess optimal dosing, and measure cost-effectiveness. Daniella A. Zipkin, MD Duke University Medical Center Durham, North Carolina, USA References 1. Wu P,Wilson K, Dimoulas P, Mills EJ. Effectiveness of smoking cessa- tion therapies: a systematic review and meta-analysis. BMC Public Health. 2006;6:300. 2. Fiore MC,Jaén CR,BakerTB,et al. Treating tobacco use and dependence: 2008 update. Clinical practice guideline. Rockville, MD: US Department of Health and Human Services. Public Health Service; 2008. 3. Cahill K, Stead LF, LancasterT. Nicotine receptor partial agonists for smoking cessation. Cochrane Database Syst Rev. 2011;(2):CD006103. 4. Leung LK, Patafio FM, Rosser WW. Gastrointestinal adverse effects of varenicline at maintenance dose: a meta-analysis. BMC Clin Pharmacol. 2011;11:15. 5. Singh S, Loke YK, Spangler JG, Furberg CD. Risk of serious adverse cardiovascular events associated with varenicline: a systematic review and meta-analysis. CMAJ. 2011;183:1359-66. Clinical impact ratings: F ######$ p ######$ Therapeutics Cytisine vs placebo for smoking cessation in adults† Outcomes Cytisine Placebo RBI (95% CI) NNT (CI) Smoking abstinence for 12 mo 8.4% 2.4% 244% (69 to 604) 17 (11 to 36) Smoking abstinence for 6 mo 10% 3.5% 185% (56 to 423) 16 (10 to 34) †Abbreviations defined in Glossary. RBI, NNT, and CI calculated from data in article. JC1-6 17 January 2012 | ACP Journal Club | Volume 156 • Number 1© 2012 American College of Physicians Question Does cytisine increase smoking cessation more than placebo in adults who receive minimal behavioral counseling? Methods Design: Randomized placebo-controlled trial. Current Controlled Trials ISRCTN37568749. Allocation: Concealed.* Blinding: Blinded (patients and clinicians).* Follow-up period: 12 months after the end of treatment. Setting: Smoking cessation clinic at the Maria Sklodowska- Curie Memorial Cancer Center in Warsaw, Poland. Patients: 740 adults (mean age 48 y, 54% women, mean number of cigarettes/d 23, mean duration of smoking 28 y) who smoked ≥ 10 cigarettes/d, wanted to permanently stop smoking, could be contacted by telephone, and were willing to attend all study ses- sions. Exclusion criteria were pregnancy or intention to become pregnant, breast-feeding, or current psychiatric disorder or other contraindicated medical condition. Intervention: Cytisine, 1.5 mg, 6 times/d (1 tablet every 2 h) for 3 days, 5 times/d for 9 days, 4 times/d for 4 days, 3 times/d for 4 days, and twice daily for 5 days (n = 370); or placebo (n = 370). Outcomes: Abstinence from smoking for 6 months and 12 months after treatment. Abstinence was defined as a self-report of < 5 cigarettes smoked in each of the past 6-month periods at 6- and 12-month follow-up visits, no cigarettes smoked in week before the follow-up visit, and an exhaled carbon monoxide level < 10 ppm. Patientfollow-up: 77% completed follow-up, and 16% were lost to follow-up but had known lack of efficacy (intention-to-treat analysis). Main results Patients in the cytisine group were more likely than those in the placebo group to have stopped smoking after 25 days of treat- ment and to be abstinent over both 6 months and 12 months (Table). Cytisine increased risk for gastrointestinal events more than placebo (14% vs 8.1%, relative risk increase 70%, 95% CI 10% to 160%, 77% follow-up); groups did not differ for other reported adverse events. Conclusion In adult smokers, cytisine increased 6-month and 12-month smoking cessation more than placebo. *See Glossary. Downloaded From: http://annals.org/ by a Pfizer Inc User on 06/16/2014 16/06/2014