Effectiveness of varenicline as an aid to smoking cessation in primary care: an observational study

Eur Addict Res. 2013;19(1):47-54. doi: 10.1159/000341638. Epub 2012 Sep 14.


Aims: Although varenicline is commonly prescribed in primary care, information on smoking-related comorbidities and the effectiveness of varenicline in this context in Germany is scarce. This study assessed the efficacy and safety of varenicline in a large sample of patients seeking smoking cessation treatment through their general practitioners. The frequency of comorbidities was also evaluated.

Methods: This was a 12-week, prospective, observational, non-comparative phase IV trial conducted in Germany. Abstinence rates at week 12 were evaluated by verbal reporting using the nicotine use inventory.

Results: Overall, 1,391 subjects were enrolled; 1,177 received study medication and were evaluated for effectiveness and safety. At the end of the study, 71.1% (95% confidence interval 68.5-73.7) of subjects were abstinent. There were a total of 205 all-causality adverse events; 2.2% were classified as serious or severe. There were no fatal adverse events. At inclusion, 66.7% of participants had at least 1 concurrent comorbidity, with chronic obstructive pulmonary disease (35.5%), hypertension (29.6%) and depression (10.4%) being the most commonly reported.

Conclusion: These real-world data indicate that varenicline is an effective and well-tolerated smoking cessation treatment when used in the primary care setting including patients with smoking-related comorbidities.

Publication types

  • Clinical Trial, Phase IV
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Benzazepines / adverse effects
  • Benzazepines / therapeutic use*
  • Comorbidity
  • Depression / epidemiology
  • Female
  • Germany / epidemiology
  • Humans
  • Hypertension / epidemiology
  • Incidence
  • Lung Diseases, Obstructive / epidemiology
  • Male
  • Middle Aged
  • Nicotinic Agonists / adverse effects
  • Nicotinic Agonists / therapeutic use
  • Observation / methods
  • Primary Health Care / methods*
  • Primary Health Care / statistics & numerical data
  • Quinoxalines / adverse effects
  • Quinoxalines / therapeutic use*
  • Smoking Cessation / methods*
  • Tobacco Use Cessation Devices / adverse effects*
  • Tobacco Use Disorder / drug therapy
  • Tobacco Use Disorder / epidemiology*
  • Varenicline


  • Benzazepines
  • Nicotinic Agonists
  • Quinoxalines
  • Varenicline