Factors Associated with Non-Adherence to Drugs in Patients with Chronic Diseases Who Go to Pharmacies in Spain.

BACKGROUND: Pharmacological non-adherence in chronic diseases is 40-65%. No predictive profile of non-adherence exists in patients with multiple chronic diseases. Our study aimed to quantify the prevalence of non-adherence to pharmacological treatment and its associated factors in patients who visit pharmacies in Spain. METHODS: This observational cross-sectional study included patients with one or more chronic diseases. The variables analyzed were demographics, diseases involved, self-medication, information about disease, and lifestyle. The main variable was adherence using the Morisky-Green test. A total of 132 pharmacies collaborated, providing 6327 patients representing all Spain regions (April-December 2016). Bivariate and multivariate analyses were performed and the area under the receiver operating characteristic (ROC) curve was calculated. RESULTS: Non-adherence was 48.4% (95% confidence interval (CI): 47.2-49.7%). The variables that reached significance in the multivariate model were: difficulty in taking medication, self-medication, desire for more information, smoking, lower physical activity, younger age and number of chronic treatments. Discrimination was satisfactory (area under the ROC curve = 70%). Our study found that 50% patients was non-adherent and we obtained a profile of variables associated with therapeutic non-adherence. CONCLUSIONS: It is cause for concern that in patients with multiple diseases and taking multiple medications, there is an association between non-adherence, self-medication and worse lifestyle.

The importance of symptoms in the longitudinal variability of clusters in COPD patients: A validation study.

BACKGROUND AND OBJECTIVE: Cluster analysis has been utilized to explore phenotypic heterogeneity in chronic obstructive pulmonary disease (COPD). To date, little is known about the longitudinal variability of clusters in COPD patients. We aimed to evaluate the 2-year cluster variability in stable COPD patients. METHODS: We evaluated the following variables in COPD patients at baseline and 2 years later: age, gender, pack-year history, body mass index (BMI), modified Medical Research Council (MMRC) scale, 6-min walking distance (6MWD), spirometry and COPD Assessment Test (CAT). Patient classification was performed using cluster analysis at baseline and 2 years later. Each patient's cluster variability after 2 years and its parameters associated with cluster change were explored. RESULTS: A total of 521 smokers with COPD were evaluated at baseline and 2 years later. Three different clusters were consistently identified at both evaluation times: cluster A (of younger age, mild airway limitation, few symptoms), cluster B (intermediate) and cluster C (of older age, severe airway limitation and highly symptomatic). Two years later, 70% of patients were unchanged, whereas 30% changed from one cluster to another: 20% from A to B; 15% from B to A; 15% from B to C; 42% from C to B and 8% from C to A. 6MWD, forced expiratory volume in 1 s (FEV1 ) % and CAT were the principal parameters responsible for this change. CONCLUSION: After 2 years of follow-up, most of the COPD patients maintained their cluster assignment. Exercise tolerance, lung function and quality of life were the main driving parameters in those who change their cluster assignment.

Prevalence, Knowledge and Attitudes Towards Smoking Among SEPAR Members. / Prevalencia, conocimiento y actitudes acerca del consumo de tabaco en los miembros de SEPAR.

The aims of this study were to estimate the prevalence of smoking among SEPAR members, and their approach to smoking cessation in their patients. An online survey was completed by 640 members (496 pulmonologists, 45 nurses, 34 thoracic surgeons, 37 physiotherapists, and 28 other specialists). Of the members interviewed, 5% confessed that they were smokers: 3.5% pulmonologists; 8.9% nurses; 8.8% thoracic surgeons, and 13.5% physiotherapists. A total of 96% of members assign a lot or quite a lot of importance to setting an example; 98% of members always or often ask their patients about their smoking habit. The most effective anti-smoking intervention, according to 77% of members, is a combination of drugs and psychological support. These results are an indicator of the awareness and commitment of SEPAR members to smoking and its cessation.

Prevalence of and Attitudes towards Smoking among Spanish Health Professionals.

BACKGROUND: The MPOWER strategy encourages suitable monitoring of the tobacco epidemic among health professionals in all countries. OBJECTIVE: To analyse the prevalence of and attitudes towards tobacco use among Spanish health professionals. METHODS: A study was conducted based on an online survey. The study population consisted of health professionals (primary care physicians, specialist physicians and nurses). The questionnaire used included questions about tobacco consumption, knowledge of and attitudes towards smoking. The sample size was calculated according to a database with 9,500 e-mail addresses and listings of health centres and hospitals all over Spain. Statistical analysis was done using the SPSS software programme. RESULTS: The study group comprised a total of 612 health professionals: 322 were women (52.6%), 196 were nurses and 416 were physicians. 11.7% of health professionals were smokers (9.6% regular smokers and 2.1% occasional smokers) and 41.3% were ex-smokers. Within the group of daily smokers, differences were observed between the nurses and the physicians: 11.2 versus 8.9% (p = 0.009). Smoking was recognized as a chronic disorder by 58.2% of health professionals, and 54.6% knew that the most effective intervention to help quit is a combination of psychological and pharmacological treatment. 56% of health professionals always asked their patients about their tobacco consumption. CONCLUSIONS: 11.7% of Spanish health professionals are smokers. We found that they have low knowledge about strategies to quit smoking and that there is a low level of therapeutic intervention on smokers.

SEPAR-ALAT Consensus Document on Antipneumoccal Vaccination in Smokers.

Streptococcus pneumoniae is responsible for several clinical syndromes, such as community-acquired pneumonia, sinusitis, otitis media, and others. The most severe clinical entity caused by this bacteria is undoubtedly invasive pneumococcal disease. Certain factors are known to increase the risk of presenting invasive pneumococcal disease, the most important being smoking habit and underlying concomitant diseases. This article comprises a consensus document on antipneumococcal vaccination in smokers, drawn up by a Smoking Expert Group from the Spanish Society of Pulmonology and Thoracic Surgery and the Latin American Chest Association.

The electronic cigarette. Official statement of the Spanish Society of Pneumology and Thoracic Surgery (SEPAR) on the efficacy, safety and regulation of electronic cigarettes.

The electronic cigarette (EC) is a device formed by three basic elements: battery, atomizer and cartridge. When assembled, it looks like a cigarette. The cartridge contains different substances: propylene glycol, glycerine and, sometimes, nicotine. When the user "vapes", the battery is activated, the atomizer is heated and the liquid is drawn in and vaporized. The smoker inhales the mist produced. Various substances have been detected in this mist: formaldehyde, acetaldehyde and acrolein and some heavy metals. Although these are found in lower concentrations than in cigarettes, they may still be harmful for the human body. Several surveys show that 3-10% of smokers regularly use e-cigarettes. A randomized study has shown that the efficacy of e-cigarettes for helping smokers to quit is similar to nicotine patches. Nevertheless, the study has relevant methodological limitations and reliable conclusions cannot be deduced. This report sets down the Position Statement of the Spanish Society of Pulmonology and Thoracic Surgery (SEPAR) on the efficacy and safety of e-cigarettes. This statement declares that e-cigarettes should be regulated as medicinal products.

Clinical application of the COPD assessment test: longitudinal data from the COPD History Assessment in Spain (CHAIN) cohort.

OBJECTIVE: The COPD Assessment Test (CAT) has been proposed for assessing health status in COPD, but little is known about its longitudinal changes. The objective of this study was to evaluate 1-year CAT variability in patients with stable COPD and to relate its variations to changes in other disease markers. METHODS: We evaluated the following variables in smokers with and without COPD at baseline and after 1 year: CAT score, age, sex, smoking status, pack-year history, BMI, modified Medical Research Council (mMRC) scale, 6-min walk distance (6MWD), lung function, BODE (BMI, obstruction, dyspnea, exercise capacity) index, hospital admissions, Hospital and Depression Scale, and the Charlson comorbidity index. In patients with COPD, we explored the association of CAT scores and 1-year changes in the studied parameters. RESULTS: A total of 824 smokers with COPD and 126 without COPD were evaluated at baseline and 441 smokers with COPD and 66 without COPD 1 year later. At 1 year, CAT scores for patients with COPD were similar (± 4 points) in 56%, higher in 27%, and lower in 17%. Of note, mMRC scale scores were similar (± 1 point) in 46% of patients, worse in 36%, and better in 18% at 1 year. One-year CAT changes were best predicted by changes in mMRC scale scores (ß-coefficient, 0.47; P < .001). Similar results were found for CAT and mMRC scale score in smokers without COPD. CONCLUSIONS: One-year longitudinal data show variability in CAT scores among patients with stable COPD similar to mMRC scale score, which is the best predictor of 1-year CAT changes. Further longitudinal studies should confirm long-term CAT variability and its clinical applicability. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT01122758; URL: www.clinicaltrials.gov.

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.

Prevalence and characteristics of three clinical phenotypes of chronic obstructive pulmonary disease (COPD).

AIM: To determine the prevalence and analyze the most relevant clinical characteristics of three clinical phenotypes of COPD: emphysema (type 1), chronic bronchitis (type 2) or COPD-asthma (type 3). METHOD: Observational, multicenter study performed with 331 COPD patients recruited in pulmonology outpatient services. The stratification in three phenotypes was performed with imaging tests, pulmonary function, and a standardized clinical questionnaire. RESULTS: The 43.2% presented an emphysematous phenotype, 44.7% were chronic bronchitic and the other 12.1% presented a phenotype showing mixed characteristics with asthma. There were no significant differences in the smoking level, in the gasometric values or time of disease evolution. Type 1 patients showed lower FEV1 values in comparison with types 2 and 3, 46.6% (21.1), 55.2% (21.2) and 54.4% (21.8), respectively (p < 0.05), and greater levels of dyspnea (p < 0.05). No significant differences were observed in the percentage of patients who had at least one exacerbation in the last year (68.8%, 63.9%, 64.9%; p = 0.25), in the number of exacerbations (p = 0.56), in the number of visits to the ER (total and due to COPD), or in the number of hospital admittances. Type 2 patients showed a greater prevalence of cardiovascular comorbidities and of sleep apnea syndrome (4.9%, 23.6% and 12.5%, respectively, p < 0.001). CONCLUSIONS: In COPD, emphysematous patients present worse pulmonary function and greater dyspnea, although there were no differences in the use of hospital health care resources. The greater comorbidity in Group 2 patients may require specific strategies in this subgroup of patients.

Chronic obstructive pulmonary disease history assessment in Spain: a multidimensional chronic obstructive pulmonary disease evaluation. Study methods and organization.

INTRODUCTION: This present paper describes the method and the organization of the study known as the COPD History Assessment In SpaiN (CHAIN), whose main objective is to evaluate the long-term natural history of a chronic obstructive pulmonary disease (COPD) patient cohort from a multidimensional standpoint and to identify clinical phenotypes, in comparison with another non-COPD control cohort. PATIENTS AND METHODS: CHAIN is a multicenter, observational study of prospective cohorts carried out at 36 Spanish hospitals. Both cohorts will be followed-up during a 5-year study period with complete office visits every 12 months and telephone interviews every 6 months in order to evaluate exacerbations and the vital state of the subjects. The recruitment period for cases was between 15 January 2010 and 31 March 2012. At each annual visit, information will be collected on: (i) clinical aspects (socio-economic situation, anthropometric data, comorbidities, smoking, respiratory symptoms, exacerbations, quality of life, anxiety-depression scale, daily life activities, treatments); (ii) respiratory function (spirometry, blood gases, hyperinflation, diffusion, respiratory pressures); (iii) BODE index (main study variable); (iv) peripheral muscle function, and (v) blood work-up (including IgE and cardiovascular risk factors). In addition, a serum bank will be created for the future determination of biomarkers. The data of the patients are anonymized in a database with a hierarchical access control in order to guarantee secure information access. The CHAIN study will provide information about the progression of COPD and it will establish a network of researchers for future projects related with COPD.

The use of the lower limit of normal as a criterion for COPD excludes patients with increased morbidity and high consumption of health-care resources.

The objective of this study is to analyze the clinical characteristics of two COPD patient populations: one diagnosed using the lower limit of normal (LLN) and another diagnosed by the GOLD criteria. We also compared the population excluded by the LLN criterion with a non-COPD control population. The COPD patients determined with the LLN criterion presented significantly lower levels of FEV1/FVC at 0.55 (0.8) vs. 0.66 (0.2), P=.000; FEV1 44.9% (14) vs. 53.8% (13), P=.000, and FVC 64.7% (17) vs. 70.4% p 0.04. The two COPD groups presented more frequent ER visits in the last year (57% and 52% of the patients, respectively, compared with 11.9% of the control group), without any statistically significant differences between the two. This same pattern was observed in the number of ER visits in the last year: 1.98 (1.6), 1.84 (1.5) and 1.18 (0.7), respectively. When we analyzed the prevalence of the comorbidities that are most frequently associated COPD, there was a clear increase in the percentage of patients who presented associated disorders compared with the control group. Nevertheless, these differences were not very relevant between the two COPD groups. The differences also were not relevant between both COPD groups in the pharmacological prescription profile. In conclusion, the use of the LLN as a criterion for establishing the diagnosis of COPD, compared with the GOLD criteria, excludes a population with important clinical manifestations and with a high consumption of health-care resources. Before its implementation, the relevance of applying this criterion in clinical practice should be analyzed.

'Smoking genes': a genetic association study.

Some controversy exists on the specific genetic variants that are associated with nicotine dependence and smoking-related phenotypes. The purpose of this study was to analyse the association of smoking status and smoking-related phenotypes (included nicotine dependence) with 17 candidate genetic variants: CYP2A6*1×2, CYP2A6*2 (1799T>A) [rs1801272], CYP2A6*9 (-48T>G) [rs28399433], CYP2A6*12, CYP2A13*2 (3375C>T) [rs8192789], CYP2A13*3 (7520C>G), CYP2A13*4 (579G>A), CYP2A13*7 (578C>T) [rs72552266], CYP2B6*4 (785A>G), CYP2B6*9 (516G>T), CHRNA3 546C>T [rs578776], CHRNA5 1192G>A [rs16969968], CNR1 3764C>G [rs6928499], DRD2-ANKK1 2137G>A (Taq1A) [rs1800497], 5HTT LPR, HTR2A -1438A>G [rs6311] and OPRM1 118A>G [rs1799971]. We studied the genotypes of the aforementioned polymorphisms in a cohort of Spanish smokers (cases, N = 126) and ethnically matched never smokers (controls, N = 80). The results showed significant between-group differences for CYP2A6*2 and CYP2A6*12 (both P<0.001). Compared with carriers of variant alleles, the odds ratio (OR) for being a non-smoker in individuals with the wild-type genotype of CYP2A6*12 and DRD2-ANKK1 2137G>A (Taq1A) polymorphisms was 3.60 (95%CI: 1.75, 7.44) and 2.63 (95%CI: 1.41, 4.89) respectively. Compared with the wild-type genotype, the OR for being a non-smoker in carriers of the minor CYP2A6*2 allele was 1.80 (95%CI: 1.24, 2.65). We found a significant genotype effect (all P≤0.017) for the following smoking-related phenotypes: (i) cigarettes smoked per day and CYP2A13*3; (ii) pack years smoked and CYP2A6*2, CYP2A6*1×2, CYP2A13*7, CYP2B6*4 and DRD2-ANKK1 2137G>A (Taq1A); (iii) nicotine dependence (assessed with the Fagestrom test) and CYP2A6*9. Overall, our results suggest that genetic variants potentially involved in nicotine metabolization (mainly, CYP2A6 polymorphisms) are those showing the strongest association with smoking-related phenotypes, as opposed to genetic variants influencing the brain effects of nicotine, e.g., through nicotinic acetylcholine (CHRNA5), serotoninergic (HTR2A), opioid (OPRM1) or cannabinoid receptors (CNR1).

[Study of prevalence and attitudes on smoking in patients on continuous home oxygen therapy. Toma study]. / Estudio de la prevalencia y actitudes sobre tabaquismo en pacientes sometidos a oxigenoterapia crónica domiciliaria. Estudio toma.

INTRODUCTION: The objective of this study is to analyse the prevalence, attitudes and characteristics of smoking in the population of patients subjected to Long Term Domiciliary Oxygen Therapy (LTDOT) in the Community of Madrid. PATIENT AND METHODS: A representative sample of 845 subjects (of which 461 (46%) were male) was obtained from a total of 11,174 who fulfilled the inclusion criteria. The mean age was 78.25 years (95% Confidence Interval (CI): 77.55-78.95; SD=10.36). A descriptive cross-sectional study was conducted based on questionnaires as well as cooximetry. RESULTS: Forty-eight subjects (5.7%; 95%CI: 4.3%-7.5%) were smokers and 438 (51.8%; 95%CI: 48.5%-55.2%) were ex-smokers. The percentage of active smokers was higher in the 60 years or less subject group (χ(2); P<0.001). The large majority (75%) of smokers were men, their proportion being significantly higher than that of current non-smokers (χ(2); P<0.003). The mean score in the Fagerström Test was 3.6. More than 65% of smokers had their first cigarette up to 30 min from getting up in the morning, and 45% of these were in a preparation phase. Seventeen percent of these subjects said that they had not received advice on quitting smoking. CONCLUSIONS: There is a high rate of smoking in patients on LTDOT, with a higher probability of males and younger subjects continuing to smoke. There is a high level of physical dependency for nicotine.

[Limitations of current treatment: unmet needs in the treatment of COPD]. / Limitaciones del tratamiento actual: necesidades no cubiertas en el tratamiento de la EPOC.

In the last few years, considerable interest has been aroused in the treatment of chronic obstructive pulmonary disease (COPD) and the dearth of therapeutic options has been replaced by a far more proactive treatment approach, reflected in the development of the various guidelines and recommendations of the scientific societies. There are three main steps in the treatment of COPD: prevention of the disease, treatment of its symptoms, progression and complications, and recovery of physical function through respiratory rehabilitation. Considerable advances have been produced in these three dimensions, but limitations have been detected, indicating areas for improvement. The most effective means to prevent the disease is smoking cessation. While there are moderately effective drugs to help individuals quit, no drugs are available to prevent relapses. Moreover, due to health policies, most patients with COPD do not receive drug treatment for smoking. The treatment of COPD and its complications is based on the use of bronchodilators, which improve symptoms and quality of life and, to a greater or lesser extent, prevent exacerbations. However, treatment aimed at the underlying pathogenic causes of the disease, which should be antiinflammatory treatment, remains an unresolved issue due to the discouraging results obtained with inhaled corticosteroids, which should always be used in combination with a bronchodilator. The development of new antiinflammatory agents, such as roflumilast, could improve the management of patients with the most severe disease and repeated exacerbations. Lastly, although respiratory rehabilitation is highly effective in helping patients recover their ability to exercise, few patients have access to this option. As with the treatment of smoking, there is a need to implement respiratory rehabilitation through simple and effective programs and with the support of the health administration.

[The UPLIFT study: future perspectives]. / Estudio UPLIFT: perspectivas futuras.

The natural history of chronic obstructive pulmonary disease (COPD) has classically been considered in terms of the rapid decrease in forced expiratory volume in 1 second (FEV(1)) and no other measure apart from smoking cessation has been demonstrated to modify the speed of this decrease. The evidence available from studies performed with tiotropium, of up to 1 year's duration, have shown that this anticholinergic drug can modify the course of COPD by acting on lung function, air entrapment, exacerbations, dyspnea and exercise tolerance, thus improving health status. This evidence has served as the basis for the design of the UPLIFT study (Understanding Potential Long-term Impacts on Function with Tiotropium), the main aim of which is to determine the effect of tiotropium on disease progression. This multicenter and multinational study has lasted for 4 years and almost 6,000 patients with COPD have participated. Data from this study are currently being analyzed and the results will shortly be made known. If the results are positive, it will be the first time that a pharmacological intervention has been able to modify the rate of FEV(1) decline, which would imply that the underlying disease is truly being modified. Positive data from the UPLIFT study would indicate that, together with smoking cessation, early treatment with tiotropium should be initiated at any stage of COPD, since both measures would have been proven to be able to modify the natural course of the disease. The probability of demonstrating maintenance of bronchodilation, as well as maintenance of the decrease in the number and severity of exacerbations found in studies conducted over a 1-year period, would represent a real change in what has been known to date about the natural course of COPD.