Varenicline in smokers with severe or very severe COPD after 24 weeks of treatment. A descriptive analysis: VALUE study.

A large number of COPD patients are smokers. The particular characteristics of this group as well as their need to quit usually require psychological counselling and pharmacological treatment to achieve abstinence and, often, intensively. Little information is available about this issue.  The main objective of the study was to evaluate the effectiveness of varenicline after 24 weeks of treatment, with continuous abstinence between weeks 9 and 24.  This study was a post-authorization, open label, observational study of prospective follow-up. Patients included were smokers with severe or very severe COPD criteria who were treated with varenicline for 24 weeks, i.e. with a 12-week extension over the usual treatment.  The outcomes in the population of subjects completing 24 weeks of follow-up were at week 24: continuous abstinence 36.8%, 7 days point prevalence abstinence 65.7%, and continuous smoking 31.5%.The outcomes in the intention-to-treat population included at baseline were: continuous abstinence 17.7% of patients, 7 days point prevalence abstinence 31.6%, continuous smoking 15.1% and not valid/unknown 51.8%.  The mean CAT score at week 24 was 15 and reduction from the baseline was 3.77 (paired T test, p<0.01). The most common adverse events reported were nausea, vivid dreams, stomach ache, insomnia, headache and vomiting.  Patients included in VALUE were active smokers despite all of them had a severe COPD which suggests a very high degree of dependence. Although the study do not allow to infer the results to the global population of smokers with severe COPD, the outcomes have shown that, at 24 weeks follow up 36.8% of the patients were successful in quitting but from 79 patients enrolled initially only 17.7% quit.

Budgetary impact analysis on funding smoking-cessation drugs in patients with COPD in Spain.

The aim of the study was to assess the budgetary impact of funding smoking-cessation drugs in COPD patients in Spain. A hybrid model (cohort and Markov) was developed for a 5-year time horizon. Only approved cessation drugs (varenicline, bupropion, and nicotine replacement therapy) were considered. Irrespective of the drug, the model allowed for an initial cessation attempt, and up to three additional attempts in case of failure or smoking relapse during a 5-year period. Drug effectiveness was based on controlled clinical trials. National Health System perspective was applied; therefore, only medical resources were included. The pharmaceutical costs for smoking-cessation drugs, extra medical follow-up as a consequence of public reimbursement, and annual savings for health costs avoided due to stopping smoking were considered. The model estimated that 17,756 COPD patients would stop smoking if public funding was available, compared with 1,303 without reimbursement. In the reimbursement scenario, the savings accounted for a total of €48.0 million, compensating for expenditures on drugs and medical visits (€40.4 million). Accumulated total additional savings in 5 years (€4.3 million) compared with the scenario without reimbursement was shown. Sensitivity analyses supported the results robustness. Funding smoking-cessation drugs in COPD patients seems to be an efficient option and a National Health System drug reimbursement scheme would represent a cost-saving policy in Spain.

Impact of legislation on passive smoking in Spain.

BACKGROUND: In 2005, the Spanish government approved Law 28/2005 on health measures against smoking; this was amended in 2010 by Law 42/2010. OBJECTIVE: The purpose of this study was to assess the impact of these laws on passive smoking. METHODS: Three epidemiological studies were conducted on a representative sample of the population via telephone surveys. The first was conducted prior to the first law coming into force, the second a year after its approval and the third a year after the approval of the second. RESULTS: Six thousand eight hundred people were surveyed in 2005, 3,289 in 2007 and 3,298 in 2011. The first survey showed that 49.5% of nonsmokers were exposed to second-hand smoke (SHS) while by 2007, following the introduction of Law 28/2005, this exposure had been reduced to 37.9% (results previously published in 2008). The 2011 survey, conducted following the introduction of Law 42/2010, showed that just 21% of people were exposed. These data indicate that overall exposure to SHS was reduced by 22% between 2005 and 2007 and by a further 16.9% between 2007 and 2011. The overall impact of Law 42/2010 is estimated to be around 44% and Law 28/2005 around 22%. CONCLUSION: Legislation introduced in Spain has markedly reduced the exposure of nonsmokers to SHS.