A real-life study of the effectiveness of different pharmacological approaches to the treatment of smoking cessation: re-discussing the predictors of success

Abstract

OBJECTIVE:To evaluate the effectiveness of nicotine replacement therapy (NRT), bupropion, nortriptyline and combination therapy and describe factors associated with treatment success.INTRODUCTION:Clinical trials clearly demonstrate the efficacy of pharmacotherapy in smoking cessation. However, it is only after its use in real‐life settings that clinical effectiveness and limitations of a treatment are fully known.METHODS:Patients attended a four‐session cognitive‐behavioral program and received medicines free of charge. Abstinence from smoking was assessed at each visit.RESULTS:A total of 868 smokers (68.8% women) were included. Their mean age was 49.6 years; the amount smoked was 25 cigarettes/day and the Fagerström Score was 6.6. Abstinence rates after 6 months and 1 year were 36.5% and 33.6%. In univariate analysis, male gender, age (>50), higher number of cigarettes smoked, cardiovascular comorbidities, longer interval from the last cigarette and combined treatment of nortriptyline plus NRT were predictive of abstinence, while neuropsychiatric comorbidities and the answer “yes” to the question “Do you smoke more often during the first hours after waking” were correlated with failure. In a multivariate model, predictors of abstinence were neuropsychiatric comorbidities, the answer “yes” to the question “Do you smoke more often during the first hours after waking” and combined treatment of nortriptyline plus NRT. Male gender and a longer period from the last cigarette were correlated with lower abstinence rate.CONCLUSION:Satisfactory success rates were obtained in a teaching hospital. Factors such as age, daily cigarette consumption, number of pack‐years and dependency score were not reliable markers of abstinence. The combination nortriptyline+NRT was independently associated with higher abstinence rates.

Tabagismo: o que tem sido abordado em periódicos brasileiros

“…Prado et al 39 , in a pragmatic clinical trial (non-randomized and non-controlled) carried out in 868 smokers (31.2% men and 68.8% women) with a mean score at the Fagerstrom Test of Nicotine Dependence (FTND) of 6 (± 2), mean monoximetry of 22 ppm, mean daily consumption of 25 (± 20) cigarettes and mean tobacco load of 39.7 packyears, observed a point rate of smoking abstinence of 33.6% in 52 weeks. Among the pharmacological treatments available, the use of nortriptyline-nicotine association was related to higher abstinence rate at one year (46.4%) with OR: 1.37 (95%CI: 1.01 -2.83, p <0.05), compared to the other groups.…”

The role of fatty acid amide hydrolase inhibition in nicotine reward and dependence

“…These therapies include nicotine replacement therapies such as gums and patches, the antidepressant bupropion (Zyban®), and the partial α4β2* nicotinic agonist varenicline (Chantix®) (Cummings and Mahoney, 2006; Jorenby et al, 2006). Unfortunately, the efficacy of these treatments remains quite modest with only 20% of patients remaining abstinent after one year (Prado et al, 2011). Consequently, there remains an essential need for more effective pharmacotherapy than existing treatments.…”

Quitting Smoking

“…In a real life study to compare effectiveness of NRT, bupropion, nortriptyline and combination therapy and to describe factors associated with treatment success, Prado et al sustain their point of view, in agreement with the findings from the meta-analysis of Wagena et al, 70 that nortriptyline is a significant treatment option, given its efficacy (comparable to those first-line options), safety and, especially, its low cost and wide availability. In their opinion, perhaps, considering the threat of a global tobacco epidemic -and even more significant impacts on the less affluent nations -the inclusion of nortriptyline in the therapeutic arsenal of smoking cessation may be a promising step towards a wider access to treatment, especially in developing countries.…”

“…However, the major limitation of this report is that it was a retrospective, uncontrolled and not randomized study and available options of treatment regimens were chosen by individual criteria on a case-by-case basis or according to the availability of medication in the public health system. 70 Clinicians need to be aware of the side effect profile and the lack of EMEA and FDA approval for nortriptyline as a tobacco dependence treatment. This medication should be considered for treating tobacco use only under a physician's supervision and in those patients unable to use first-line medications because of contra-indications or just in patients who have been unable to quit using first-line medications.…”