1 / 22

Journal Club

Journal Club. Sidharth Bagga MD. Cytisus laborium L. (Golden rain acacia). Case. CC: “ I’d like to quit, but it is cheaper to keep smoking ” 56 male with 20 pack year smoking history Seen in clinic in follow up Has had 4 unsuccessful attempts at quitting smoking Hx of HTN

niel
Download Presentation

Journal Club

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Journal Club Sidharth Bagga MD

  2. Cytisus laborium L. (Golden rain acacia)

  3. Case • CC: “I’d like to quit, but it is cheaper to keep smoking” • 56 male with 20 pack year smoking history • Seen in clinic in follow up • Has had 4 unsuccessful attempts at quitting smoking • Hx of HTN • Patient is a construction worker and not very eager to spend his beer money on smoking cessation treatment anymore • So what do you do now? • 1. Smoking cessation tricks (impotence, wrinkles, etc) • 2. Ask, document and move on • 3. Varencycline • 4. Nicotine replacement • 5. New non approved Cytisine

  4. Background / Context? • Smoking Prevalence • 1960s – 42% to 2010s – 20% • Tobacco use remains chief avoidable cause of death in US • Many clinicians do not offer smoking cessation • Only 20% of smokers are ready to attempt quit at any time • 95% of unaided attempts fail • Pts typically consume 50% of recommended dose of medications • Only complete about half of smoking cessation counseling • Treatment availability / ease of use? • If treatment delayed or separate location, only 10% follow through • If same location and immediate, 1/3rd follow through Schweikert et al, Lancet, 2009

  5. Cytisine Nicotine

  6. Journal Club

  7. Research Question • Assess Cytisine’s • efficacy and safety in a context that could be replicated globally • relatively short treatment goal (25 days) • minimal contact with health professionals.

  8. Design / Subjects • Prospective, randomized, single center, double-blind trial between 12/2007 & 9/2010 in Poland. • Inclusion Criteria • Adults smoke > 10 cigs/day + willing to stop permanently, literate, provide consent • Exclusion Criteria • Pregnancy, breast feeding, current psychiatric d/o, medical contraindication for Cytisine (arterial HTN + advanced arteriosclerosis) • Sampling • No other smoking cessation drugs current • Relapse: > 5 cigs used since enrollment, no smoking in last week, breath CO < 10ppm

  9. Study Procedures • Variable block randomization (eliminates early/late bias) • First Visit • Age, sex, employment, marital status, Nicotine Dependence (FTND), # of cigs/day, duration of smoking, & quit attempts • Beck Depression Inventory • 6 months • Phone contacts • If abstinent: return to clinic, CO in exhaled breath, Depression • 12 months (same) • Adverse Reactions • Asked, if ‘Yes’ then verbatim copied and compiled according to standard adverse reaction data

  10. Measurements - Outcomes • Primary Outcome • 12 month of abstinence from smoking • Changed from original 6 months before unblinding/data analysis • Secondary Outcome • Abstinence at 6 months and point prevalence at 12 months (week before visit) • Criteria for abstinence • Fewer than 5 cig in last 6 months • Confirmed with less than 10 ppm of CO in exhaled breath

  11. Statistical Analysis • Sample Size • Calculated need for 740 pts to show a difference of 6 points b/w groups to show percentage reduction in abstinence with 80% power & p < .05 • Intention to treat analysis • Categorical variables – x2 and Fischer Exact test • Logistic regression to examine efficacy with adjustment from baseline characteristics • P < .05 was considered statistically significant

  12. Study Enrollment & Follow Up

  13. Baseline Characteristics

  14. Cytisine administration DAY 1-3 DAY 4-12 DAY 13-16 DAY 17-20 DAY 20-25 5 tabs/day 2 tabs/day 3 tabs/day 4 tabs/day 6 tabs/day Total: 101 tablets QUIT DATE

  15. Study Procedures

  16. Results

  17. Adverse Events

  18. Discussion • Evidence of efficacy of Cytisine as an aid in smoking cessation • More gastrointestinal adverse events • Rate of discontinuation / dose reduction (same as placebo) • Relative Rate • Cytisine (3.4) higher than Varenicline (2.3) & Nicotine (1.6) • Absolute rate of Abstinence • Lower than varenicline, but similar to nicotine replacement • Treatment period (4, 6, 8, 12 weeks) • May reduce cravings & make cigs less satisfying, like Varenicline (a2b4 receptor)

  19. Limitations • Adults with previous attempts? Which medications? • Outcomes at 12 weeks? Standard for other drug regimens • Need to compare to current standard of care

  20. Conclusion • Cytisine needs FDA approval • Studies to assess efficacy in conjunction with cognitive feedback • Cheap, effective alternative

  21. JAMA Article Assesment: Therapy • Are the results of the study valid? • Was the assignment of patients to treatments randomized? Yes • Were all pts who entered the trial properly accounted for and attributed at its conclusion? Yes • Was follow-up complete? Yes • Were pts analyzed in the groups to which they were randomized? Yes • Were patients, health workers, and study personnel blind to treatment?Yes • Were the groups similar at the start of the trial? Yes • Aside from the experimental intervention, were the groups treated equally? Yes

  22. JAMA Article Assesment: Therapy • What were the results? • How large was the treatment effect? • How precise was the estimate of the treatment effect? • Will the results help me in caring for my patients? • Can the results be applied to my patient care? Yes (bulgarian drugs) • Were all clinically important outcomes considered? SOME • Are the likely treatment benefits worth the potential harms and costs? Yes

More Related