Risk of ischaemic stroke associated with antiepileptic drugs: a population-based case-control study in Catalonia.

BACKGROUND: Cerebrovascular disorders have occurred more frequently in some Central Nervous System (CNS) disorders, such as epilepsy. Some CNS drugs have been associated with increased stroke risk. Our aim was to estimate the risk of ischaemic stroke in patients exposed to antiepileptic drugs (AED). METHODS: Population-based matched case-control study using SIDIAP database, based in electronic health records from primary healthcare from Catalonia, Spain. Cases were those patients with a registered diagnosis of first stroke during 2009-2014. Up to 10 controls were selected for each case and matched by sex, age, and geographic area and without a prior diagnosis of stroke. We considered global drug exposure to AED, past and current exposure and exposure in monotherapy to each AED. RESULTS: 2,865 cases and 19,406 controls were exposed to AED during the study period. Global exposure to levetiracetam [(ORadj3.3, CI95 % 2.8-4.0)], phenytoin [ORadj1.5, CI95 % 1.2-41.9)], and valproic acid [(ORadj 1.3, CI95 % 1.1-1.6)], showed significantly association to ischaemic stroke that was also maintained with current exposure of levetiracetam [ORadj4.1, CI95 % 3.3-5.2)] and valproic acid [ORadj1.4, CI95 % 1.1-1.9)]. Current levetiracetam monotherapy showed a very high risk of ischaemic stroke [(ORadj 5.1, CI95 % 3.7-6.9)]. CONCLUSIONS: Drugs used for other conditions than epilepsy (pregabalin, gabapentin) were the most used AED and both did not show a risk. Levetiracetam shows a risk for stroke even when assessed in current monotherapy. The lack of data regarding the link with diagnosis and severity in our study makes it necessary to conduct further studies to confirm or dismiss our results, focussing on levetiracetam.

Clinico-epidemiological characteristics of men and women with a new diagnosis of chronic obstructive pulmonary disease: a database (SIDIAP) study.

BACKGROUND: The risk of developing Chronic Obstructive Pulmonary Disease (COPD), the associated comorbidities and response to bronchodilators might differ in men and women. The objective of this study was to determine the prevalence of COPD and the clinic-epidemiological characteristics of primary care patients with COPD according to gender. METHODS: This is a cross-sectional study using electronic healthcare records Catalonia (Spain), during the 01/01/2012-31/12/2017 period. Patients from the SIDIAP database (System for the Development of Research in Primary Care) were included (5,800,000 patients registered in 279 primary care health centres). Clinic-demographic characteristics, comorbidities and blood tests results were collected for each patient. Adjusted OR (ORa) with logistic regression methods were used to determine variables associated with men and women. RESULTS: From an initial sample of 800,899 people, 24,135 (3%) were considered COPD patients, and 22.9%were women. The most common risk factors in women were bronchiectasis (ORa = 20.5, SD = 19.5-21.6), age > 71 years (ORa = 18.8; SD = 17.3-20.5), cor pulmonale (ORa = 5.2; SD = 4.3-6.7) and lung cancer (ORa = 3.6, SD = 3.2-4.0). Men and women presented the same comorbidities, though the strength of association was different for each gender. CONCLUSIONS: Patients suffering high comorbidity rates. Comorbidities are similar in men and women, although the strength of association varies according to gender. Women are more susceptible to the harmful effects of smoking and present a higher proportion of bronchiectasis and OSAS.

[Prevalence and characteristics of chronic obstructive pulmonary disease in non-smokers]. / Prevalencia y características de la enfermedad pulmonar obstructiva crónica en no fumadores.

OBJECTIVE: The objective of the study was to know the profile of patients diagnosed with chronic obstructive pulmonary disease (COPD) and who have never been smokers. DESIGN: A transversal study. LOCATION: Primary Care Centre of Pla d'Urgell (Primary care setting in Lleida, Spain). PARTICIPANTS: 512 patients older than 40 years with COPD from Primary Care Centre of Pla d'Urgell with a compatible spirometry [forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) ratio <0.7) to the beginning of the study. MAIN MEASUREMENTS: The dependent variable was de COPD in non-smokers and the independents were variables collected from the information on the respiratory clinical history, the risk factors of the patients and on quality of life. We designed a predictor model of COPD in non-smokers compared to smokers. RESULTS: 33.2% of COPD patients had never been smokers, 59.4% of whom were women. The average FEV1 for non-smokers was 70.5 (SD=17.1), higher than 62.6 (SD=18.5) for smokers/former smokers (p<0.001). The coverage of pneumococcal vaccination 23V was better in non-smokers (75.3%), p<0.001. COPD in non-smokers (compared to smokers/former smokers) were: mostly women (OR=16.46), older (OR=1.1), with better FEV1 (OR=1.1), better perception of quality, EuroQoL-5D (OR=0.8), with lower prevalence of diabetes (OR=0.5), lower level of studies (OR=0.2), and with fewer previous hospitalizations (OR=0.3). CONCLUSIONS: The study evidences a high proportion of non-smokers in COPD patients. Our study aims that older women with less severity would be associated with an increased risk of COPD in non-smokers. It seems to indicate that COPD in non-smokers would appear at later ages and would be milder than smoking-related COPD.

Predictors and Association With Clinical Outcomes of the Changes in Exercise Capacity After Transcatheter Aortic Valve Replacement.

BACKGROUND: At present, there are no objective data specifically examining the clinical impact of variations in exercise capacity post-transcatheter aortic valve replacement (TAVR). We describe the changes in exercise capacity between baseline and 6 months post-TAVR, and ascertain factors associated with and clinical implications of a lack of improvement in exercise capacity post-TAVR. METHODS: A total of 305 patients (mean age, 79±9 years; 44% men; Society of Thoracic Surgeons predicted risk mortality score, 6.7±4.2%) undergoing TAVR completed both baseline and follow-up exercise capacity assessments at 6 months post-TAVR. Exercise capacity was evaluated by the 6-minute walk test (6MWT). Clinical outcomes were compared between patients displaying greater than (n=152; improving group) versus less than (n=153; nonimproving group) the median percentage change in distance walked between baseline and 6-month follow-up examinations. The primary outcome measure was clinical event rates, measured from the 6-month post-TAVR period onward. Further dichotomization according to baseline 6MWT distance (less than versus more than median walking distance, or slow walker versus fast walker) was also assessed. RESULTS: The mean overall distances walked pre- and post-TAVR (6 months post-TAVR) were 204±119 and 263±116 m, respectively (Δ6MWT=60±106 m), with 219 (72%) patients demonstrating an increase in their walking distance (median percentage increase of the entire population was 20% [interquartile range, 0%-80%]). Factors independently correlated with reduced exercise capacity improvement included a range of baseline clinical characteristics (older age, female sex, chronic obstructive pulmonary disease; P<0.05 for all), periprocedural major or life-threatening bleeding (P=0.009) and new-onset anemia at 6 months post-TAVR (P=0.009). Failure to improve the 6MWT distance by at least 20% was independently associated with all-cause mortality (P=0.002) and cardiovascular death or rehospitalization for cardiovascular causes (P=0.001). Baseline slow walkers who were able to improve the 6MWT distance presented with significantly better outcomes than nonimprovers (P=0.01 for all-cause mortality; P=0.001 for cardiovascular end point). CONCLUSIONS: Approximately one-third of patients undergoing TAVR did not improve their exercise capacity postprocedure. The lack of functional improvement post-TAVR was predicted by a mix of baseline and periprocedural factors translating into poorer clinical outcomes. These results suggest that systematically implementing exercise capacity assessment pre- and post-TAVR may help to improve patient risk stratification.

Safety of cilostazol in peripheral artery disease: a cohort from a primary healthcare electronic database.

BACKGROUND: Cilostazol has been associated with spontaneous reports of cardiovascular adverse events and serious bleeding. The objective of this study is to determine the relative risk of cardiovascular adverse events or haemorrhages in patients with peripheral artery disease treated with cilostazol in comparison to pentoxifylline users. METHODS: Population-based cohort study including all individuals older than 40 who initiated cilostazol or pentoxifylline during 2009-2011 in SIDIAP database. The two treatment groups were matched through propensity score (PS). RESULTS: Nine thousand one hundred twenty-nine patients met inclusion criteria and after PS matching, there were 2905 patients in each group. 76% of patients were men, with similar mean ages in both groups (68.8 for cilostazol and 69.4 for pentoxifylline). There were no differences in bleeding, cerebrovascular and cardiovascular events between both groups. CONCLUSIONS: Patients treated with cilostazol were different from those treated with pentoxifylline at baseline, so they were matched through PS. We did not find differences between treatment groups in the incidence of bleeding or cardiovascular and cerebrovascular events. Cilostazol should be used with precaution in elderly polymedicated patients.

Predictors of CPAP compliance in different clinical settings: primary care versus sleep unit.

BACKGROUND: Good adherence to continuous positive airway pressure (CPAP) treatment improves the patient's quality of life and decreases the risk of cardiovascular disease. Previous studies that have analyzed the adherence to CPAP were performed in a sleep unit (SU) setting. The involvement of primary care (PC) in the management of obstructive sleep apnea (OSA) patients receiving CPAP treatment could introduce factors related to the adherence to treatment. OBJECTIVES: The objective was to compare the baseline predictors of CPAP compliance in SU and PC settings. METHODS: OSA patients treated with CPAP were followed for 6 months in SU or PC setting. We included baseline clinical and anthropometrical variables, the Epworth Sleep Scale (ESS) score, the quality of life index, and the Charlson index. A logistic regression was performed for each group to determine the CPAP compliance predictors. Discrimination and calibration were performed using the area under the curve and Hosmer-Lemeshow tests. RESULTS: We included 191 patients: 91 in the PC group and 100 in the SU group. In 74.9% of the patients, the compliance was ≥ 4 h per day, with 80% compliance in the SU setting and 69.2% compliance in the PC setting (p = 0.087). The predictors of CPAP compliance were different between SU and PC settings. Body mass index, ESS, and CPAP pressure were predictors in the SU setting, and ESS, gender, and waist circumference were predictors in the PC setting. CONCLUSIONS: The predictors of adequate CPAP compliance vary between SU and PC settings. Detecting compliance predictors could help in the planning of early interventions to improve CPAP adherence.

The Use of a Binary Composite Endpoint and Sample Size Requirement: Influence of Endpoints Overlap.

Although composite endpoints (CE) are common in clinical trials, the impact of the relationship between the components of a binary CE on the sample size requirement (SSR) has not been addressed. We performed a computational study considering 2 treatments and a CE with 2 components: the relevant endpoint (RE) and the additional endpoint (AE). We assessed the strength of the components' interrelation by the degree of relative overlap between them, which was stratified into 5 groups. Within each stratum, SSR was computed for multiple scenarios by varying the events proportion and the effect of the therapy. A lower SSR using CE was defined as the best scenario for using the CE. In 25 of 66 scenarios the degree of relative overlap determined the benefit of using CE instead of the RE. Adding an AE with greater effect than the RE leads to lower SSR using the CE regardless of the AE proportion and the relative overlap. The influence of overlapping decreases when the effect on RE increases. Adding an AE with lower effect than the RE constitutes the most uncertain situation. In summary, the interrelationship between CE components, assessed by the relative overlap, can help to define the SSR in specific situations and it should be considered for SSR computation.

Overview of the Impact of Depression and Anxiety in Chronic Obstructive Pulmonary Disease.

BACKGROUND: Anxiety and depression are common entities in patients diagnosed with COPD. However, the impact that they have on the exacerbation of illness is scarcely studied. OBJECTIVE: To determine if the presence of anxiety and depression is associated with a greater risk of frequent exacerbation (≥2 per year) in patients diagnosed with COPD. PATIENTS AND METHODS: A cohort study that analysed frequent exacerbation and associated factors in 512 patients monitored during 2 years. Exacerbations were defined as events that required antibiotic/s and/or systemic corticosteroids (moderate) or hospitalization (serious). Variables of interest were recorded for each patient, including anxiety and depression (Hospital Anxiety and Depression Scale), and we analysed their association with frequent exacerbation through the adjusted odds ratio (aOR) by means of a logistic regression model. RESULTS: The prevalence of anxiety/depression at the start of the study was of 15.6%. During the 2 years of monitoring, 77.9% of the patients suffered at least moderate-to-severe exacerbation. 54.1% were frequent exacerbators. Anxiety/depression were strongly associated with moderate-severe frequent exacerbation in the crude analysis (ORc = 2.28). In the multivariate analysis, the risk factors also associated with frequent exacerbation were being overweight (aOR 2.78); obesity (aOR 3.02); diabetes (aOR 2.56) and the associated comorbidity (BODEx) (ORa = 1.45). CONCLUSIONS: The prevalence of anxiety/depression in COPD patients is high, and they are relevant risk factors in frequent exacerbation although the effect is lower in the multivariate analysis when adjusting for different variables strongly associated with exacerbation.

Metabolic risk management, physical exercise and lifestyle counselling in low-active adults: controlled randomized trial (BELLUGAT).

BACKGROUND: The primary aim of this study is to evaluate the effectiveness of different doses (intensity) of supervised exercise training - concomitant with lifestyle counselling - as a primary care intervention tool for the management of metabolic syndrome risk factors in low-active adults with one or more such factors (programme name in Catalan: Bellugat de CAP a peus). METHODS/DESIGN: Three-arm, randomized controlled clinical trial implemented in the primary care setting, with a duration of 40 weeks (16 weeks intervention and 24-week follow-up). Adults aged 30 to 55 years with metabolic risk factors will be randomized into three intervention groups: 1) aerobic interval training (16 supervised training lessons) plus a healthy lifestyle counselling programme (6 group and 3 individual meetings); 2) low-to-moderate intensity continuous training (16 supervised training lessons) plus the same counselling programme; or 3) the counselling- programme without any supervised physical exercise. The main output variables assessed will be risk factors for metabolic syndrome (waist circumference, blood pressure, and levels of plasma triglycerides, high-density lipoproteins and glucose), systemic inflammation, cardiorespiratory fitness, physical activity and sedentary behaviour, dietary habits, health-related quality of life, self-efficacy and empowerment. Economic factors will also be analysed in order to determine the cost-effectiveness of the programme. These variables will be assessed three times during the study: at baseline, at the end of the intervention, and at follow-up. We estimate to recruit 35 participants per group. DISCUSSION: The results of this study will provide insight into the immediate and medium-term effects on metabolic risk and lifestyle of a combined approach involving aerobic interval training and a multidisciplinary behavioural intervention. If effective, the proposed intervention would provide both researchers and practitioners in this field with a platform on which to develop similar intervention programmes for tackling the repercussions of an unhealthy lifestyle. TRIAL REGISTRATION: Clinical trials.gov. NTC02832453 . Registered 6 July 2016 (retrospectively registered).

Occupational burnout and empathy influence blood pressure control in primary care physicians.

BACKGROUND: Good physician-patient communication can favor the adoption of healthy lifestyle habits, which is essential in high blood pressure (BP) management. More empathic physicians tend to have lower burnout and better communication skills. We analyzed the association between burnout and empathy among primary care physicians and nurses and investigated the influence on BP control performance. METHODS: Descriptive study conducted in 2014 investigating burnout and empathy levels in 267 primary care physicians and nurses and BP control data for 301,657 patients under their care. We administered the Maslach Burnout Inventory and the Jefferson Scale of Physician Empathy and defined good BP control as a systolic BP <130 mmHg. RESULTS: Low burnout and high empathy were observed in 58.8% and 33.7% of practitioners, respectively. Burnout and empathy were significantly negatively associated (p < 0.009). Practitioners with high empathy and low burnout had significantly better BP control and performance than those with low empathy and high burnout (p < 0.05). CONCLUSIONS: Low burnout and high empathy were significantly associated with improved BP control and performance, possibly in relation to better physician/nurse-patient communication.

Effectiveness of a motivational intervention on overweight/obese patients in the primary healthcare: a cluster randomized trial.

BACKGROUND: Overweight and obesity are common health problems which increase the risk of developing several serious health conditions. The main difficulty in the management of weight-loss lies in its maintenance, once it is achieved. The aim of this study was to investigate whether a motivational intervention, together with current clinical practice, was more efficient than a traditional intervention, in the treatment of overweight and obesity and whether this intervention reduces cardiovascular risk factors associated with overweight and obesity. METHODS: Multi-centre cluster randomized trial with a 24-month follow-up included 864 overweight/obese patients randomly assigned. Motivational intervention group (400 patients), delivered by a nurse trained by an expert psychologist, in 32 sessions, 1 to 12 fortnightly, and 13 to 32, monthly, on top of their standard programmed diet and exercise. The control group (446 patients), received the usual follow-up. RESULTS: Weight reduction was statistically significant in the second year with a mean reduction of 1.0 Kg in the control group and 2.5 Kg in the intervention group (p = 0. 02). While 18.1% of patients in the control group reduced their weight by more than 5%, this percentage rose to 26.9% in the intervention group, which is statistically significant (p = 0.04). Patients in the motivational intervention group had significantly greater improvements in triglycerides and APOB/APOA1ratio. CONCLUSIONS: The results highlight the importance of the group motivational interview in the treatment of overweight /obese patients in primary care, and in the improvement of their associated cardiovascular risks factors. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01006213 October 30, 2009.

Descriptive study of association between quality of care and empathy and burnout in primary care.

BACKGROUND: The doctor-patient relationship is a crucial aspect of primary-care practice Research on associations between quality of care provision and burnout and empathy in a primary care setting could improve this relationship. METHODS: Cross-sectional study of family physicians (108) and nurses (112) of twenty-two primary care centers in the health district of Lleida, Spain. Empathy and burnout were measured using the Jefferson Physician Empathy Scale and the Maslach Burnout Inventory, while quality of care delivery was evaluated using Quality Standard Indicator scores. JPSE and MBI results were grouped into low, medium, and high scores to analyze associations with QSI scores and sociodemographic variables. RESULTS: The mean QSI score recorded for the family physicians and nurses was 665 (out of a total of 1000). Higher, albeit insignificant, QSI scores were observed for practitioners with high burnout. No differences were observed according to level of empathy (p > 0.05). The differences with respect to sex, age, and area of practice (urban vs rural center) were not significant. Practitioners with low empathy had higher QSI scores than those with high empathy (672.8 vs. 654.4) while those with high burnout had higher scores than those with low burnout (702 vs. 671). CONCLUSIONS: Burnout and empathy did not significantly influence quality of care delivery scores in 22 primary care centers. More studies, however, are needed to investigate the unexpected trend observed that suggests that physicians and nurses with higher levels of burnout provide higher quality care.

Subclinical Carotid Atherosclerosis in Asymptomatic Subjects With Type 2 Diabetes Mellitus.

BACKGROUND: Subjects with type 2 diabetes mellitus are considered to be at high risk for cardiovascular disease. The identification of carotid atherosclerosis is a validated surrogate marker of cardiovascular disease. Nurses are key professionals in the improvement and intensification of cardiovascular preventive strategies. AIMS: The aim is to study the presence of carotid atherosclerosis in a group of asymptomatic subjects with type 2 diabetes mellitus and no previous clinical cardiovascular disease. METHODS: A total of 187 patients with type 2 diabetes mellitus and 187 age- and sex-matched subjects without type 2 diabetes mellitus were studied in this cross-sectional, observational, cohort study. Standard operational procedures were applied by the nursing team regarding physical examination and carotid ultrasound assessment. Common, bulb, and internal carotid arteries were explored by measuring intima-media thickness and identifying atherosclerotic plaques. RESULTS: Carotid intima-media thickness (c-IMT) and carotid plaque prevalence were significantly greater in diabetic subjects than in the control group. Carotid plaques and c-IMT were more frequent in men than in women and increased with increasing age. In the multivariate analysis, age, gender, waist circumference, systolic blood pressure, and hypercholesterolemia were positively associated with c-IMT, whereas age, gender, and weight were positively associated with carotid plaque. CONCLUSION: The current nurse-led study shows that subjects with type 2 diabetes mellitus have a high prevalence of subclinical atherosclerosis that is associated with cardiovascular risk factors.

Insulin secretion in patients with latent autoimmune diabetes (LADA): half way between type 1 and type 2 diabetes: action LADA 9.

BACKGROUND: The study of endogenous insulin secretion may provide relevant insight into the comparison of the natural history of adult onset latent autoimmune diabetes (LADA) with types 1 and 2 diabetes mellitus. The aim of this study was to compare the results of the C-peptide response to mixed-meal stimulation in LADA patients with different disease durations and subjects with type 2 and adult-onset type 1 diabetes. METHODS: Stimulated C-peptide secretion was assessed using the mixed-meal tolerance test in patients with LADA (n = 32), type 1 diabetes mellitus (n = 33) and type 2 diabetes mellitus (n = 30). All patients were 30 to 70 years old at disease onset. The duration of diabetes in all groups ranged from 6 months to 10 years. The recruitment strategy was predefined to include at least 10 subjects in the following 3 disease onset categories for each group: 6 to 18 months, 19 months to 5 years and 5 to 10 years. RESULTS: At all time-points of the mixed-meal tolerance test, patients with LADA had a lower stimulated C-peptide response than the type 2 diabetes group and a higher response than the type 1 diabetes group. The same results were found when the peak or area under the C-peptide curve was measured. When the results were stratified by time since disease onset, a similar pattern of residual insulin secretory capacity was observed. CONCLUSIONS: The present study shows that the magnitude of stimulated insulin secretion in LADA is intermediate between that of type 1 and type 2 diabetes mellitus.

Risk of exacerbation in chronic obstructive pulmonary disease: a primary care retrospective cohort study.

BACKGROUND: The risk of exacerbation in chronic obstructive pulmonary disease (COPD) depends on the severity of disease and other less well known factors. Predictive models of exacerbation are more accurate than the forced expiratory volume in one second (FEV1). The objective was to design a model that predicts the risk of exacerbation in COPD. METHODS: Retrospective cohort study with data from the electronic medical records of patients diagnosed with COPD in the province of Lleida (Spain). A total of 2501 patients were followed during 3 years. The dependent variable was acute exacerbation; independent variables were: clinical parameters, spirometry results, severity of disease, influenza and 23-valent pneumococcal immunisation, comorbidities, smoking and history of exacerbation. The association of these variables with disease exacerbation was measured by the adjusted odds ratio using a logistic regression model. RESULTS: Mean age at the start of the study was 68.38 years (SD = 11.60) and 74.97% patients were men; severity of disease was considered mild in 50.82% of patients, moderate in 35.31%, severe in 9.44% and very severe in 4.44%. During the three year study period up to 83.17% of patients experienced at least one exacerbation. Predictive factors in the model were age, gender, previous exacerbations, influenza and 23-valent pneumococcal immunisations, number of previous visits to the General Practice and severity (GOLD), with an area under the ROC curve (AUROC) of 0.70. CONCLUSIONS: This model can identify patients at high risk of acute exacerbation. Preventive measures and modification of treatment in these high-risk patients would improve survival.

Effect of Clopidogrel and Aspirin vs Aspirin Alone on Migraine Headaches After Transcatheter Atrial Septal Defect Closure: The CANOA Randomized Clinical Trial.

IMPORTANCE: The occurrence of new-onset migraine attacks is a complication of transcatheter atrial septal defect (ASD) closure. It has been suggested that clopidogrel may reduce migraine attacks after ASD closure. OBJECTIVE: To assess the efficacy of clopidogrel, used in addition to taking aspirin, for the prevention of migraine attacks following ASD closure. DESIGN, SETTING, AND PARTICIPANTS: Randomized, double-blind clinical trial performed in 6 university hospitals in Canada. Participants were 171 patients with an indication for ASD closure and no history of migraine. INTERVENTIONS: Patients were randomized (1:1) to receive dual antiplatelet therapy (aspirin + clopidogrel [the clopidogrel group], n = 84) vs single antiplatelet therapy (aspirin + placebo [the placebo group], n = 87) for 3 months following transcatheter ASD closure. The first patient was enrolled in December 2008, and the last follow-up was completed in February 2015. MAIN OUTCOMES AND MEASURES: The primary efficacy outcome was the monthly number of migraine days within the 3 months following ASD closure in the entire study population. The incidence and severity of new-onset migraine attacks, as evaluated by the Migraine Disability Assessment questionnaire, were prespecified secondary end points. A zero-inflated Poisson regression model was used for data analysis. RESULTS: The mean (SD) age of the participants was 49 (15) years and 62% (106) were women. Patients in the clopidogrel group had a reduced mean (SD) number of monthly migraine days within the 3 months following the procedure (0.4 [95% CI, 0.07 to 0.69] days) vs the placebo group (1.4 [95% CI, 0.54 to 2.26] days; difference, -1.02 days [95% CI, -1.94 to -0.10 days]; incident risk ratio [IRR], 0.61 [95% CI, 0.41 to 0.91]; P = .04) and a lower incidence of migraine attacks following ASD closure (9.5% for the clopidogrel group vs 21.8% for the placebo group; difference, -12.3% [95% CI, -23% to -1.6%]; odds ratio [OR], 0.38 [95% CI, 0.15 to 0.89]; P = .03). Among patients with migraines, those in the clopidogrel group had less-severe migraine attacks (zero patients with moderately or severely disabling migraine attacks vs 37% [7 patients] in the placebo group; difference, -36.8% [95% CI, -58.5% to -15.2%]; P = .046). There were no between-group differences in the rate of patients with at least 1 adverse event (16.7% [14 patients] in the clopidogrel group vs 21.8% [19 patients] in the placebo group; difference, -5.2% [95% CI, -17% to 6.6%]; P = .44). CONCLUSIONS AND RELEVANCE: Among patients who underwent transcatheter ASD closure, the use of clopidogrel and aspirin, compared with aspirin alone, resulted in a lower monthly frequency of migraine attacks over 3 months. Further studies are needed to assess generalizability and durability of this effect. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00799045.

[Risk factors for mortality in patients with chronic obstructive pulmonary disease]. / Factores asociados a la mortalidad global en los pacientes diagnosticados de enfermedad pulmonar obstructiva crónica.

OBJECTIVE: To identify risk factors of mortality in patients with chronic obstructive pulmonary disease (COPD). DESIGN: A retrospective cohort study. LOCATION: Primary care setting in Lleida, Spain. PARTICIPANTS: 2.501 patients older than 40 years with at least a spirometry in the 24 months prior to the beginning of the study were followed for 3 years. MAIN MEASUREMENTS: The dependent variable was the overall mortality in the period 11/01/2010-10/31/2013; and the independents: spirometric parameters, severity (GOLD) and clinical variables. Their association with mortality was analyzed by calculating the adjusted odds ratio using a non-conditional logistic regression model. RESULTS: The average age of 2.501 patients at the beginning of the study was 68.4 years (SD=11.6). 75.0% were males. 50.8% had a mild severity COPD, followed by moderate (35.3%), severe (9.4%) and very severe (4.4%). Mortality rate for the all period was 12.55%. The variables of the predictive model were: age, male sex, previous exacerbations, number of visits to primary care, comorbidity, smoking, severity of COPD (GOLD) and not receiving influenza vaccination, with an area under the ROC curve of 0.76. CONCLUSIONS: This model, easy and quick to apply, would identify those patients at increased risk of mortality and who could benefit from preventive strategies to improve their survival.

[Effectiveness of influenza vaccination in preventing hospital admission due to exacerbations of chronic obstructive pulmonary disease]. / Efectividad de la vacunación antigripal para evitar el ingreso hospitalario por agudización de la enfermedad pulmonar obstructiva crónica.

INTRODUCTION: The main objective was to determine the effectiveness of influenza vaccination in preventing hospitalization due to exacerbation of chronic obstructive pulmonary disease (COPD). One secondary objective was to estimate the prevalence of vaccination, and to describe the factors that were associated with being vaccinated. METHODS: A retrospective cohort study was conducted that included 1,323 patients diagnosed with COPD in the Health Centre of the Pla d'Urgell (Lleida, Spain). They were classified into two cohorts: cohort1, patients vaccinated against seasonal influenza (campaign 2011/12), and cohort2, non-vaccinated. The number of patients in both cohorts requiring hospital admission for exacerbation of the disease between the 12/01/2011 and the 03/15/2012 was quantified. Information about the variables of interest was recorded for each patient. A univariate and multivariate analysis was performed. The effectiveness of vaccination was calculated with the formula: E=(1-OR)×100. The ORs and their 95% confidence interval (95%CI) were determined by multivariate logistic regression models. RESULTS: Just over half (55.3%) of the patients had been vaccinated. Vaccinated patients were older and had more associated comorbidity. At the same time, they were less hospitalized (3.0% versus 8.9%; P=.001). The crude and adjusted effectiveness of influenza vaccination in this population subgroup was 68.4% (95%CI: 47.5-81.0) and 90.8 (95%CI: 96.8-88.2), respectively. CONCLUSION: Influenza vaccination is effective in preventing hospitalization due to acute exacerbations in COPD patients. However, immunization coverage is not as high as desired. Designing programs to increase the rate of vaccination in this population would reduce the number of hospital admissions for COPD exacerbation.

[Cigarette smoking prevalence and associated factors in secondary school children in Catalunya]. / Prevalencia y factores asociados al consumo de tabaco en alumnos de enseñanza secundaria de Cataluña.

OBJECTIVE: The aim of this study was to analyze those factors associated with cigarette smoking in adolescent school children, in order to plan future school interventions for promoting good health strategies developed by the schools and Primary Health Care professionals. DESIGN: Cross-sectional study with a two-stage cluster sampling. SETTING: The study included 97 schools, and was carried out in 2005-06 in Catalonia (Spain). PARTICIPANTS: 14-16 year-old secondary school children. MAIN MEASURES: The survey was based on a self-administered paper-based questionnaire that collected sociodemographic variables, academic level, health status, family variables, sexual relations, addictive substances, mood state, and variables related to opinions on cigarette smoking The association between these variables and smoker/non-smoker variable was analyzed, as well as factors that could increase the probability of becoming a smoker using multilevel models. RESULTS: A total of 9340 completed questionnaires, including 4653 from males, were received from the pupils, with a mean age of 15.2 years. The results showed that 71.1% of pupils were non-smokers, 75% of whom were males and 67.3% of females. The following factors increased the probability of becoming a smoker (OR and 95%CI): being a female 0.60 (0.53-0.68), being in the 4(th) year 1.27 (1.12-1.43), low academic performance 3.38 (2.74-4.17), self-reported regular/poor health status 2.81 (2.21-3.58), smoking parents 1.68 (1.45-1.95), alcohol consumption 5.05 (4.35-5.86), having 3 or more problems of mood state 1.22 (1.05-1.41), living without parents 1.59 (1.07-2.38), agreeing with tobacco industry advertising 1.64 (1.45-1.85) and believing that tobacco acts as a relaxant 3.57 (3.23-4.17). CONCLUSIONS: Although the majority of pupils were non-smokers, smoking was more prevalent among females. The factors associated with cigarette smoking in the adolescents included sociodemographic, sociocultural, and personal environmental factors, as well as their opinions on the habit.