Pilar de Lucas

Home vs Hospital-Based Pulmonary Rehabilitation for Patients With Chronic Obstructive Pulmonary Disease: A Spanish Multicenter Trial

OBJECTIVE To compare the effects of a simple home pulmonary rehabilitation program and an intensive hospital-based program in terms of the exercise tolerance and health-related quality of life (HRQL) of patients with severe chronic obstructive pulmonary disease (COPD). PATIENTS AND METHODS Patients in this prospective, multicenter trial were randomized to 2 groups to receive hospital or home pulmonary rehabilitation. Patients in both groups attended 2 informative sessions about the disease and 4 physical therapy sessions. Patients in the hospital group then carried out a structured exercise program while home group patients performed low intensity exercises at home without supervision. RESULTS Twenty-eight patients were randomized to the hospital rehabilitation group and 23 to the home group. Both groups showed a similar improvement on the 6-minute walk test (mean difference, 8.7 m; P=.61). HRQOL measured with the Chronic Respiratory Questionnaire also improved in both groups, but the change was greater on the emotional function domain in the hospital rehabilitation group (mean difference between groups, 0.58 on a scale for which the smallest clinically relevant difference is 0.5 points). The benefits were maintained in both groups 6 months after the programs ended. CONCLUSIONS This study demonstrates that the improvement in exercise tolerance achieved by COPD patients with an unsupervised home pulmonary rehabilitation program is similar to the gains of patients in an intensive hospital-based program. However, the hospital program afforded greater benefit on the HRQOL emotional function domain.

Misdiagnosis of patients receiving inhaled therapies in primary care

Aim: To analyze the accuracy of diagnosis in a population receiving inhaled therapies due to respiratory diseases in a primary care setting. Method: Noninterventional, multicenter, cross-sectional, observational epidemiologic study methodology. Results: A total of 9752 subjects were evaluated. Of these, 4188 (42.9%) patients were diagnosed with asthma, 4175 (42.8%) with chronic obstructive pulmonary disease (COPD), and 1389 had a diagnosis of disease of unknown origin. Of those over the age of 40 years, 4079 (50.9%) had COPD and 2877 (35.9%) had asthma. Sixty percent of the subjects were men, and the proportion of men was higher in patients with COPD (83.2%) than in the group with asthma (39.8%, P < 0.0001). Of subjects with COPD, 17.3% had mild, 55.3% had moderate, 24.1% had severe, and 3.2% had very severe disease. With regard to the level of severity of asthma, 34.9% of subjects had intermittent, 34.6% had mild persistent, 27.1% had moderate persistent, and 3.5% had severe persistent disease. Only 13.9% of patients in the COPD group had all the characteristics of COPD based on the Global Initiative for Chronic Obstructive Lung Disease criteria and an absence of the characteristics of asthma. Conclusions: The majority of patients receiving inhaled therapy in primary care did not have an accurate diagnosis according to current international guidelines for COPD and asthma. More initiatives for improving diagnostic accuracy in respiratory diseases must be implemented in primary care.

Health-related quality of life in outpatients with COPD in daily practice: the VICE Spanish study

Background The objective of this study was to measure health-related quality of life (HRQL) in outpatients with chronic obstructive pulmonary disease (COPD) and to assess differences in HRQL according to age, gender, and severity of COPD. Methods A total of 9405 patients (79% men, mean age 68 years) participated in a cross-sectional study. HRQL was measured with the Short Form 12 Health Survey Questionnaire (SF-12). Severity of COPD was graded into three levels according to forced expiratory volume in one second value. Results COPD severity was mild in 33.8% of cases, moderate in 49.3% and severe in 16.8%. The mean physical component summary (PCS-12) and mental component summary (MCS-12) scores were 36.8 ± 10.4 and 47.2 ± 11.2, respectively. General health and physical functioning domains were those with the lowest scores. The mean MCS-12 scores were significantly higher in men (47.9 ± 10.9) than in women (44.1 ± 11.8) (P < 0.001). Patients older than 60 years rated HRQL worse than patients aged 40–59 years. There were statistically significant differences according to severity of disease in the mean scores of all domains of the PCS-12 and MCS-12 scales. Conclusions The present findings show the influence of female gender, older age and moderate-to-severe of airflow limitation on HRQL in outpatients with COPD attended in daily practice.

Distribution and Outcomes of a Phenotype-Based Approach to Guide COPD Management: Results from the CHAIN Cohort

Rationale The Spanish guideline for COPD (GesEPOC) recommends COPD treatment according to four clinical phenotypes: non-exacerbator phenotype with either chronic bronchitis or emphysema (NE), asthma-COPD overlap syndrome (ACOS), frequent exacerbator phenotype with emphysema (FEE) or frequent exacerbator phenotype with chronic bronchitis (FECB). However, little is known on the distribution and outcomes of the four suggested phenotypes. Objective We aimed to determine the distribution of these COPD phenotypes, and their relation with one-year clinical outcomes. Methods We followed a cohort of well-characterized patients with COPD up to one-year. Baseline characteristics, health status (CAT), BODE index, rate of exacerbations and mortality up to one year of follow-up were compared between the four phenotypes. Results Overall, 831 stable COPD patients were evaluated. They were distributed as NE, 550 (66.2%); ACOS, 125 (15.0%); FEE, 38 (4.6%); and FECB, 99 (11.9%); additionally 19 (2.3%) COPD patients with frequent exacerbations did not fulfill the criteria for neither FEE nor FECB. At baseline, there were significant differences in symptoms, FEV1 and BODE index (all p<0.05). The FECB phenotype had the highest CAT score (17.1±8.2, p<0.05 compared to the other phenotypes). Frequent exacerbator groups (FEE and FECB) were receiving more pharmacological treatment at baseline, and also experienced more exacerbations the year after (all p<0.05) with no differences in one-year mortality. Most of NE (93%) and half of exacerbators were stable after one year. Conclusions There is an uneven distribution of COPD phenotypes in stable COPD patients, with significant differences in demographics, patient-centered outcomes and health care resources use.

Non-invasive ventilation in obesity hypoventilation syndrome without severe obstructive sleep apnoea

Background Non-invasive ventilation (NIV) is an effective form of treatment in patients with obesity hypoventilation syndrome (OHS) who have concomitant severe obstructive sleep apnoea (OSA). However, there is a paucity of evidence on the efficacy of NIV in patients with OHS without severe OSA. We performed a multicentre randomised clinical trial to determine the comparative efficacy of NIV versus lifestyle modification (control group) using daytime arterial carbon dioxide tension (PaCO2) as the main outcome measure. Methods Between May 2009 and December 2014 we sequentially screened patients with OHS without severe OSA. Participants were randomised to NIV versus lifestyle modification and were followed for 2 months. Arterial blood gas parameters, clinical symptoms, health-related quality of life assessments, polysomnography, spirometry, 6-min walk distance test, blood pressure measurements and healthcare resource utilisation were evaluated. Statistical analysis was performed using intention-to-treat analysis. Results A total of 365 patients were screened of whom 58 were excluded. Severe OSA was present in 221 and the remaining 86 patients without severe OSA were randomised. NIV led to a significantly larger improvement in PaCO2 of −6 (95% CI −7.7 to −4.2) mm Hg versus −2.8 (95% CI −4.3 to −1.3) mm Hg, (p<0.001) and serum bicarbonate of −3.4 (95% CI −4.5 to −2.3) versus −1 (95% CI −1.7 to −0.2 95% CI)  mmol/L (p<0.001). PaCO2 change adjusted for NIV compliance did not further improve the inter-group statistical significance. Sleepiness, some health-related quality of life assessments and polysomnographic parameters improved significantly more with NIV than with lifestyle modification. Additionally, there was a tendency towards lower healthcare resource utilisation in the NIV group. Conclusions NIV is more effective than lifestyle modification in improving daytime PaCO2, sleepiness and polysomnographic parameters. Long-term prospective studies are necessary to determine whether NIV reduces healthcare resource utilisation, cardiovascular events and mortality. Trial registration number NCT01405976; results.

Documento de consenso «Uso adecuado de los corticoides inhalados en la enfermedad pulmonar obstructiva crónica»

INTRODUCTION Indications for inhaled corticosteroids (IC) in combination with long-acting bronchodilators (LABD) are well defined in clinical practice guidelines. However, there are some doubts about their efficacy and safety. The aim of this document is to establish an expert consensus to clarify these issues. METHOD A coordinator group was formed, which systematically reviewed the scientific evidence with the aim of identifying areas of uncertainty about the efficacy of ICs, the adverse effects associated with their use and criteria for withdrawal. Their proposals were submitted to a panel of experts and the Delphi technique was used to test the level of consensus. RESULTS Twenty-five experts participated in the panel, and consensus was reached on the use of IC in the mixed chronic obstructive pulmonary disease (COPD)-asthma phenotype and in frequent exacerbators, and on not using IC in association with LABD for improving lung function in COPD. There was no general consensus on restricting the use of IC to prevent adverse effects. The panel did agree that IC withdrawal is feasible but should be undertaken gradually, and patients who have discontinued must be evaluated in the short term. CONCLUSIONS Consensus was reached regarding the indication of IC in mixed COPD-asthma and frequent exacerbator phenotypes. The potential for adverse effects must be taken into consideration, but there is no consensus on whether limiting use is justified. The withdrawal of ICs was uniformly agreed to be feasible.

Protective Cardiovascular Effect of Sleep Apnea Severity in Obesity Hypoventilation Syndrome

BACKGROUND Obesity hypoventilation syndrome (OHS) is associated with a high burden of cardiovascular morbidity (CVM) and mortality. The majority of patients with OHS have concomitant OSA, but there is a paucity of data on the association between CVM and OSA severity in patients with OHS. The objective of our study was to assess the association between CVM and OSA severity in a large cohort of patients with OHS. METHODS In a cross-sectional analysis, we examined the association between OSA severity based on tertiles of oxygen desaturation index (ODI) and CVM in 302 patients with OHS. Logistic regression models were constructed to quantify the independent association between OSA severity and prevalent CVM after adjusting for various important confounders. RESULTS The prevalence of CVM decreased significantly with increasing severity of OSA based on ODI as a continuous variable or ODI tertiles. This inverse relationship between OSA severity and prevalence of CVM was seen in the highest ODI tertile and it persisted despite adjustment for multiple confounders. Chronic heart failure had the strongest negative association with the highest ODI tertile. No significant CVM risk change was observed between the first and second ODI tertiles. Patients in the highest ODI tertile were younger, predominantly male, more obese, more hypersomnolent, had worse nocturnal and daytime gas exchange, lower prevalence of hypertension, better exercise tolerance, and fewer days hospitalized than patients in the lowest ODI tertile. CONCLUSIONS In patients with OHS, the highest OSA severity phenotype was associated with reduced risk of CVM. This finding should guide the design of future clinical trials assessing the impact of interventions aimed at decreasing cardiovascular morbidity and mortality in patients with OHS. TRIAL REGISTRY Clinicaltrial.gov; No.: NCT01405976; URL: www.clinicaltrials.gov.

Lack of association of ischemic heart disease with COPD when taking into account classical cardiovascular risk factors

The aim of our study is to determine whether chronic obstructive pulmonary disease (COPD) is an independent risk factor for ischemic heart disease and whether this association is related with a greater prevalence of classical cardiovascular risk factors. Ours is a case-control cross-sectional study design. Cases were hospital patients with ischemic heart disease in stable phase, compared with control hospital patients. All patients underwent post-bronchodilator (PBD) spirometry, a standardized questionnaire, and blood analysis. COPD was defined as per GOLD PBD forced expiratory volume in the first second (FEV1)/forced vital capacity (FVC) < 0.70. In our series of patient cases (n = 204) and controls (n = 100), there were 169 men in the case group (83%) and 84 in the control group (84%). Ages were 67 and 64 years, respectively (P < 0.05). There were no significant differences by weight, body mass index (BMI), packyears, leukocytes, or homocysteine. The abdominal perimeter was significantly greater in cases (mean 101 cm ± standard deviation [SD] 10 versus 96 cm ± 11; P < 0.000). Both groups also had significant differences by C-reactive protein (CRP), fibrinogen, and hemoglobin values. In univariate analysis, increased risks for cases to show with individual classical cardiovascular risk factors were seen, with odds ratio (OR) 1.86 and 95% confidence interval (CI) (1.04–3.33) for diabetes mellitus, dyslipidemia (OR 2.10, 95% CI: 1.29–3.42), arterial hypertension (OR 2.47, 95% CI: 1.51–4.05), and increased abdominal perimeter (OR 1.71, 95% CI: 1.06–2.78). Percent predicted PBD FEV1 was 97.6% ± 23% in the patient group and 104% ± 19% in the control group (P = 0.01), but the prevalence of COPD was 24.1% in cases and 21% in controls. Therefore, COPD was not associated with ischemic heart disease: at the crude level (OR 1.19, 95% CI: 0.67–2.13) or after adjustment (OR 1.14, 95% CI:0.57–2.29). In conclusion, COPD was not associated with ischemic heart disease. The greater prevalence of classical cardiovascular risk factors in COPD patients could explain the higher occurrence of ischemic heart disease in these patients.

Health-related quality of life in outpatient women with COPD in daily practice: The MUVICE Spanish Study

AIMS A cross-sectional multicenter study was designed to assess health-related quality of life (HRQL) in women with chronic obstructive pulmonary disease (COPD) who were attended in the outpatient setting in actual conditions of the daily practice. METHODS A total of 1786 women with COPD (mean age of 66.5 years) and 1661 pairs of men and women matched by age and COPD severity participated in a cross-sectional study. HRQL was measured with the Short Form 12 Health Survey Questionnaire (SF-12). RESULTS The mean PCS-12 and MCS-12 scores were 36.5+/-10.3 and 44.1+/-11.8, respectively. General health and physical functioning domains were those with the lowest scores, whereas role emotional and social functioning were those with the highest scores. The percentage of women with low HRQL increased according to age, whereas the percentage of women with high or normal HRQL decreased significantly. In relation to COPD severity, more women rated HRQL as low in the physical component than in the mental component. HRQL correlated significantly with FEV(1) in both PCS-12 and MCS-12 scales. As expected, an inverse significant correlation between HRQL and degree of dyspnea in the PCS-12 and the MCS-12 scales was observed. Women had also a significantly worse HRQL than men in all physical and mental domains. CONCLUSIONS In outpatient women with COPD, HRQL was impaired especially the physical component of the SF-12. For the same age and severity of COPD, women showed significantly lower scores in all physical and mental domains of the SF-12 than men.

The variability of respiratory symptoms and associated factors in COPD

Few studies have investigated the variability of COPD-related symptoms or factors related to symptom variability. This observational, prospective, multicentre study was conducted to describe the number and intensity of morning and night-time respiratory symptoms and their variability over one week using the Night-time and Early Morning Symptoms of COPD Instruments (NiSCI and EMSCI) to evaluate stable COPD patients. Logistic regression analyses were performed to investigate factors associated with symptom variability. A total of 2669 patients were evaluated (mean age, 67.7 years; 80.9% men; mean FEV1 50.6%). Of these, 48% reported night-time symptoms and 71% reported morning symptoms. Of the 2293 patients who completed the NiSCI and EMSCI, 90% showed variability in either symptom number (89.6%) or symptom intensity (15.8%). More severe dyspnoea, more exacerbations during the previous year and the exacerbator or mixed COPD-asthma phenotypes were associated with variability in symptom number or intensity. Anxiety was significantly associated with variability in symptom number and intensity. Most COPD patients showed symptom variability over a weeklong period, especially in terms of symptom number. Several COPD-related factors, mainly factors related to more severe disease and more frequent exacerbations, were associated with increased symptom variability.