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The Fagerström Test for Nicotine Dependence as a predictor of smoking abstinence: a pooled analysis of varenicline clinical trial data.

AbstractINTRODUCTION:
We explored the relationship between the Fagerström Test for Nicotine Dependence (FTND) and smoking abstinence rates in 10 randomized, double-blind placebo-controlled Phase 2-4 varenicline studies.
METHODS:
Participants were adult smokers (≥10 cigarettes/day) who were motivated to quit. Efficacy end points included continuous abstinence rate (CAR) for weeks 9-24 analyzed, by baseline FTND and Heaviness of Smoking Index (HSI) scores, and treatment. Data were analyzed using logistic regression models.
RESULTS:
Overall, 2,763 varenicline (M [SD] FTND score: 5.6 [2.2]) and 2,229 placebo subjects (5.5 [2.1]) were included in the analysis. An increase of one unit in baseline FTND or HSI score decreased the odds of abstinence at Week 24 by 11% (odds ratio [OR] 0.89, 95% CI 0.86-0.92, p < .0001) and 18% (OR 0.82, 95% CI 0.79-0.87, p < .0001), respectively. Treatment had a significant impact on CAR 9-24: odds of abstinence were increased threefold for varenicline versus placebo (OR 3.3, 95% CI 2.8-3.8, p < .0001). There was no interaction between treatment and FTND (p = .98) or HSI score (p = .97) for CAR 9-24. The HSI score predicted abstinence outcome as effectively as the FTND score.
CONCLUSION:
Abstinence rates decreased with increasing dependence scores. There was no interaction between treatment and baseline FTND or HSI score, suggesting that they have no effect on the efficacy of varenicline versus placebo. These results also suggest that the HSI may be as effective at predicting smoking cessation outcome as the whole FTND questionnaire.
AuthorsKarl Fagerström, Cristina Russ, Ching-Ray Yu, Carla Yunis, Jonathan Foulds
JournalNicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco (Nicotine Tob Res) Vol. 14 Issue 12 Pg. 1467-73 (Dec 2012) ISSN: 1469-994X [Electronic] England
PMID22467778 (Publication Type: Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Benzazepines
  • Nicotinic Agonists
  • Quinoxalines
  • Varenicline
Topics
  • Adult
  • Benzazepines (therapeutic use)
  • Double-Blind Method
  • Female
  • Humans
  • Linear Models
  • Male
  • Middle Aged
  • Nicotinic Agonists (therapeutic use)
  • Placebo Effect
  • Quinoxalines (therapeutic use)
  • Randomized Controlled Trials as Topic
  • Smoking (drug therapy)
  • Smoking Cessation (methods)
  • Smoking Prevention
  • Surveys and Questionnaires
  • Tobacco Use Disorder (diagnosis, epidemiology, prevention & control)
  • Varenicline

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