Frequency and Associated Factors of Suicidal Ideation in Patients with Chronic Obstructive Pulmonary Disease.

We aimed to examine the prevalence of suicidal ideation in patients with chronic obstructive pulmonary disease (COPD) and the association between demographic and clinical variables and the occurrence of suicidal thoughts. This was a cross-sectional study. Sociodemographic and clinical data were recorded, and questionnaires were used to assess depressive symptoms (Beck Depression Inventory), comorbidities (Charlson Index), cognitive performance (Mini Mental State Examination), and quality of life (EuroQoL-5 dimensions and CAT). Specific questions about suicide-related behavior were included. Multivariate logistic regression analysis identified the significant factors associated with previous suicidal ideation and suicide attempts. The analysis included 1190 subjects. The prevalence of suicidal ideation and suicide attempts were 12.1% and 2.5%, respectively. Severely depressed patients had the highest prevalence of suicide-related behavior. The adjusted logistic model identified factors significantly associated with suicidal ideation: sex (odds ratio (OR) for women vs. men = 2.722 (95% confidence interval (CI) = 1.771-4.183)), depression score (OR = 1.163 (95% IC = 1.127-1.200)), and Charlson Index (OR 1.228 (95% IC 1.082-1.394)). Suicidal ideation is common in COPD patients, especially in women. While addressing suicidal ideation and suicide prevention, clinicians should first consider the management of depressive symptomatology and the improvement of coping strategies.

Evaluation of Changes in Control Status in COPD: An Opportunity for Early Intervention.

BACKGROUND: Control has been proposed as a dynamic tool that can capture changes in the clinical status of patients with COPD. METHODS: This prospective, multicenter, observational study aimed to compare changes in control over a 3-month period with changes in risk level, Global Initiative for Chronic Obstructive Lung Disease (GOLD) stage, and clinical phenotype (nonexacerbator, asthma-COPD overlap, or exacerbator with emphysema or with chronic bronchitis). Control was defined as the presence of low clinical impact, assessed according to the degree of dyspnea, use of rescue medication, physical activity and sputum color, and clinical stability assessed by clinical changes and exacerbations in the last 3 months. Impact and stability were alternatively assessed with COPD Assessment Test (CAT) scores. RESULTS: We included 354 patients, with a mean FEV1 of 49.8% ± 16.9%. At 3 months, the proportion of controlled patients was 50.3% according to clinical evaluation and 47.8% according to CAT score. Eighty-seven patients (29.2%) changed their control status as assessed by clinical variables, and 85 patients (28.5%) changed their status according to CAT score. In contrast, the risk level only changed in 26 patients (8.7%) (P < .001), 27 patients (9.1%) experienced changes in their clinical phenotype (P < .001), and 59 patients (19.8%) experienced changes in their GOLD stage (P = .008). Patients who showed an improvement in control status had better CAT scores at the end of follow-up (P < .001). CONCLUSIONS: In only 3 months, almost one-third of patients experienced changes in their control status. Changes in control status were significantly more frequent than changes in phenotype, risk level, and GOLD stage, and resulted in significant changes in health status.

Clinical Features Of Women With COPD: Sex Differences In A Cross-Sectional Study In Spain ("The ESPIRAL-ES Study").

Aim: This cross-sectional multicenter study was performed aimed at describing the clinical characteristics of women with COPD attended in routine daily practice in Spain. Methods and results: Of a total of 1610 consecutive patients diagnosed with COPD recruited in primary care centers and pneumology services throughout Spain over a 90-day period, 17.9% (n=286) were women, with a median age of 62 years. Differences in COPD phenotypes by sex were statistically significant (P = 0.002). Males as compared with females showed a higher prevalence of non-exacerbator (47.9% vs 42.2%) and exacerbator with chronic bronchitis (22.9% vs 18.8%) phenotypes, whereas the ACOS phenotype was more common among females (21.7% vs 12.9%). The mean (SD) CAT score was similar in men than in women (20.8 [9.0] vs 21.2 [8.7], P = 0.481), as well as the impact of the disease on the quality of life according to CAT scores of <5 (no impact), 5-9 (low), 10-20 (medium), >20 (high), and >30 (very high). Sex-related differences according to smoking status were statistically significant (P < 0.001), with a higher percentage of men as compared with women in the groups of current smokers and ex-smokers; never-smokers were higher in women (9.1%) than in men (0.6%). The mean number of comorbidities was 2.01 (1.43) (95% CI 1.93-2.09) in males and 1.99 (1.42) (95% CI 1.83-2.16) (P = 0.930) in females, but cardiovascular diseases (hypertension, ischemic heart disease, chronic heart failure) were more frequent in men, whereas metabolic disorders (osteoporosis) were more frequent in women. Conclusion: This study highlights the impact of COPD in women and the importance of continuing sex-based research in tobacco-related respiratory diseases.

Geographic variations of the prevalence and distribution of COPD phenotypes in Spain: "the ESPIRAL-ES study".

PURPOSE: The purpose of this study was to assess the prevalence of COPD phenotypes at a national level and to determine their geographic distribution among different autonomous communities in Spain. PATIENTS AND METHODS: A total of 1,610 patients (82% men, median age 67 years) recruited in primary care centers and pneumology services participated in an observational, cross-sectional, and multicenter study. Phenotypes evaluated were the non-exacerbator phenotype, the asthma-COPD overlap syndrome (ACOS), the exacerbator phenotype with emphysema, and the exacerbator phenotype with chronic bronchitis. RESULTS: The non-exacerbator phenotype was the most common (46.7%) followed by exacerbator with chronic bronchitis (22.4%) and exacerbator with emphysema (16.4%). The ACOS phenotype accounted for the lowest rate (14.5%). For each phenotype, the highest prevalence rates were concentrated in two or three autonomous communities, with relatively similar rates for the remaining regions. Overall prevalence rates were higher for the non-exacerbator and the exacerbator with chronic bronchitis phenotypes than for ACOS and the exacerbator with chronic bronchitis phenotypes. Differences in the distribution of COPD phenotypes according to gender, age, physician specialty, smoking habit, number of comorbidities, quality of life assessed with the COPD Assessment Test, and BODEx index (body mass index, airflow obstruction, dyspnea, and exacerbations) were all statistically significant. CONCLUSION: Differences in the prevalence rates of COPD phenotypes among the Spanish autonomous communities have been documented. Mapping the distribution of COPD phenotypes is useful to highlight regional differences as starting point for comparisons across time. This geographic analysis provides health-care planners a valuable platform to assess changes in COPD burden at nationwide and regional levels.

Depressive status explains a significant amount of the variance in COPD assessment test (CAT) scores.

Background: COPD assessment test (CAT) is a short, easy-to-complete health status tool that has been incorporated into the multidimensional assessment of COPD in order to guide therapy; therefore, it is important to understand the factors determining CAT scores. Methods: This is a post hoc analysis of a cross-sectional, observational study conducted in respiratory medicine departments and primary care centers in Spain with the aim of identifying the factors determining CAT scores, focusing particularly on the cognitive status measured by the Mini-Mental State Examination (MMSE) and levels of depression measured by the short Beck Depression Inventory (BDI). Results: A total of 684 COPD patients were analyzed; 84.1% were men, the mean age of patients was 68.7 years, and the mean forced expiratory volume in 1 second (%) was 55.1%. Mean CAT score was 21.8. CAT scores correlated with the MMSE score (Pearson's coefficient r=-0.371) and the BDI (r=0.620), both p<0.001. In the multivariate analysis, the usual COPD severity variables (age, dyspnea, lung function, and comorbidity) together with MMSE and BDI scores were significantly associated with CAT scores and explained 45% of the variability. However, a model including only MMSE and BDI scores explained up to 40% and BDI alone explained 38% of the CAT variance. Conclusion: CAT scores are associated with clinical variables of severity of COPD. However, cognitive status and, in particular, the level of depression explain a larger percentage of the variance in the CAT scores than the usual COPD clinical severity variables.

Active smoking and COPD phenotype: distribution and impact on prognostic factors.

PURPOSE: Smoking can affect both the phenotypic expression of COPD and factors such as disease severity, quality of life, and comorbidities. Our objective was to evaluate if the impact of active smoking on these factors varies according to the disease phenotype. PATIENTS AND METHODS: This was a Spanish, observational, cross-sectional, multicenter study of patients with a diagnosis of COPD. Smoking rates were described among four different phenotypes (non-exacerbators, asthma-COPD overlap syndrome [ACOS], exacerbators with emphysema, and exacerbators with chronic bronchitis), and correlated with disease severity (body mass index, obstruction, dyspnea and exacerbations [BODEx] index and dyspnea grade), quality of life according to the COPD assessment test (CAT), and presence of comorbidities, according to phenotypic expression. RESULTS: In total, 1,610 patients were recruited, of whom 46.70% were classified as non-exacerbators, 14.53% as ACOS, 16.37% as exacerbators with emphysema, and 22.40% as exacerbators with chronic bronchitis. Smokers were predominant in the latter 2 groups (58.91% and 57.67%, respectively, P=0.03). Active smoking was significantly associated with better quality of life and a higher dyspnea grade, although differences were observed depending on clinical phenotype. CONCLUSION: Active smoking is more common among exacerbator phenotypes and appears to affect quality of life and dyspnea grade differently, depending on the clinical expression of the disease.

Cognitive status among patients with chronic obstructive pulmonary disease.

PURPOSE: We investigated the association between cognitive impairment and chronic obstructive pulmonary disease (COPD), taking into account demographic and clinical variables evaluated during routine practice. PATIENTS AND METHODS: We performed a post hoc analysis of a cross-sectional study that included subjects with stable COPD. Sociodemographic and clinical information was recorded using the Body mass index, airflow Obstruction, Dyspnea and Exacerbations index and the Charlson comorbidity index. Cognitive performance was studied by the mini-mental state examination, with a score less than 27 indicating clinical impairment. Depressive symptoms, physical activity, and quality of life (EuroQoL-5 dimensions and COPD Assessment Test) were also evaluated. RESULTS: The analysis included 940 subjects. The prevalence of cognitive impairment was 39.4%. Multivariate logistic regression models revealed that cognitive impairment was associated with educational level (odds ratio [OR] =0.096, 95% confidence interval [CI] =0.011-0.447) and poorer quality of life measured by the EuroQoL-5 dimensions social tariff (OR =0.967, 95% CI =0.950-0.983). When questionnaires were not included in the analysis, cognitive impairment was associated with educational level (OR =0.063, 95% CI =0.010-0.934), number of exacerbations (OR =11.070, 95% CI =1.450-84.534), Body mass index, airflow Obstruction, Dyspnea and Exacerbations index score (OR =1.261, 95% CI =1.049-1.515), and the Charlson comorbidity index (OR =1.412, 95% CI =1.118-1.783). CONCLUSION: Cognitive impairment is common in COPD and is associated with low educational level, higher disease severity, and increased comorbidity. This could have therapeutic implications for this population.

Factors associated with depression and severe depression in patients with COPD.

BACKGROUND: Depression is very prevalent in COPD and may be associated with poor clinical outcomes. METHOD: This was a multicenter, cross-sectional study aimed at evaluating the prevalence of depression and moderate to severe depression in COPD. Depressive symptoms were evaluated with the Beck's Depression Inventory. The COPD assessment test (CAT) and the EuroQoL-5 dimensions (EQ-5D) questionnaires were used to evaluate health-related quality of life (HRQoL). Severity of COPD was assessed with the BODEx index and physical activity was estimated by the mean self-declared time walked per day. RESULTS: A total of 836 patients were included and up to 74.6% had some degree of depression with 51.5% having moderate to severe depression. On multivariate analysis, moderate to severe depression was associated with suicidal ideation (OR, 6.12; 95% confidence interval (CI), 1.36-28.24), worse quality of life: EQ-5D (OR, 0.89; 95%CI, 0.86-0.93) and worse CAT scores (OR, 1.32; 95%CI, 1.19-1.46). When questionnaires were not included in the analysis, significant depression was associated with the Charlson comorbidity index, minutes walked per day and BODEx score. CONCLUSIONS: Depression is frequent in COPD and is associated with suicidal ideation, impaired HRQoL, increase in comorbidities, a reduction in physical activity and increased severity of COPD measured by the BODEx index.

Comparison of inhibition of cutaneous histamine reaction of ebastine fast-dissolving tablet (20 mg) versus desloratadine capsule (5 mg): a randomized, double-blind, double-dummy, placebo-controlled, three-period crossover study in healthy, nonatopic adults.

BACKGROUND: Ebastine is a long-acting, second-generation, selective histamine H1-receptor antagonist. A fast-dissolving tablet formulation of ebastine has been developed at 10- and 20-mg doses, with the intention of facilitating administration to patients experiencing problems with swallowing, including those confined to bed and elderly people, as well as those who may need to use ebastine when they do not have easy access to water to aid swallowing a tablet. OBJECTIVES: This study was conducted to assess the pharmacodynamic effects (ie, inhibition of wheal response to cutaneous histamine challenge, and subjective assessments of itching, flare, and pain) and tolerability of the fast-dissolving 20-mg ebastine tablet formulation compared with desloratadine 5-mg capsule and placebo. Acceptability and convenience of the fast-dissolving tablet were also evaluated. METHODS: This double-blind, double-dummy, randomized, placebo-controlled, 3-period crossover study was conducted at the Drug Research Centre, Department of Clinical Pharmacology, the Hospital de la Santa Creu i Sant Pau, Barcelona, Spain. Healthy, nonatopic, white adults aged 18 to 40 years were randomly assigned to 1 of 6 study sequences: ABC, ACB, BAC, BCA, CBA, or CAB, where A was the ebastine fast-dissolving 20-mg tablet, B was the desloratadine 5-mg capsule, and C was placebo. All study drugs were given orally once daily (8-9 AM) on days 1 to 5 of each study period. Study periods were separated by a washout period of 7 to 10 days. Histamine skin-prick test (SPT) challenge was performed before study drug administration on day 1 of each period (baseline), and then every 20 minutes for 2 hours after administration and again after 24 hours. The final SPT was 24 hours after the day-5 dose was administered. The primary end point was inhibition o f the histamine response, defined as the percentage reduction from baseline wheal area 24 hours after 5 days of administration. Subjective symptoms (itching, flare, and pain) were assessed by subjects using visual analog scales every 20 minutes for 2 hours after administration on day 1. At study end, acceptability (taste, convenience, and overall preference) of the fast-dissolving tablet and capsule formulations were assessed using a questionnaire completed by subjects. Tolerability was assessed using physical examination, laboratory analysis, physician questioning, and spontaneous reporting. RESULTS: Thirty-six people were randomized (22 women, 14 men; mean [SD] age, 24.7 [4.1] years; mean [SD] weight, 63.2 [9.9] kg); 35 completed the study (1 subject was lost to follow-up after the second study period). Unadjusted mean (SD) wheal areas 24 hours after dose administration on day 5 were 72.9 (29.5), 115.0 (32.1), and 146.7 (32.2) mm(2), for ebastine, desloratadine, and placebo, respectively. Mean differences in reduction from baseline in wheal area were 29.0% for ebastine versus desloratadine and 43.7% for ebastine versus placebo (both, P < 0.001). Corresponding unadjusted mean (SD) wheal areas 24 hours after administration of the first dose on day 1 were 76.5 (22.5), 128.9 (24.0), and 140.5 (33.1) mm(2). Mean itching, flare, and pain ratings were not significantly different between study drugs. Results from the preference questionnaire indicated that the majority (80%) preferred the ebastine fast-dissolving tablet to the desloratadine capsule (and hypothetically also to tablets and oral solution, which were not tested in this study). Ninety-seven percent of subjects were of the opinion that compliance in the home setting would be facilitated by the fas-tdissolving tablet formulation. Fourteen adverse events (AEs) were reported in 9 (25%) volunteers; all AEs were of mild or moderate intensity. Five occurred with ebastine 20 mg (intermittent somnolence, back pain, pharyngolaryngeal pain, pyrexia, and oral pain [1 patient each]), 5 occurred with desloratadine 5 mg (asthenia [2 patients] and dry mouth, somnolence, and back pain [1 patient each]), and 4 occurred with placebo (diarrhea [2 patients] and somnolence and headache [1 patient each]). The relationship with the study drugs was considered unlikely in 6 cases and possible in the remaining 8 cases. An additional AE (back pain) occurred during a washout period. CONCLUSIONS: In this small study in healthy, nonatopic white subjects, inhibition of the response to histamine injection was significantly greater with the ebastine 20-mg fast-dissolving tablet compared with desloratadine 5-mg capsule and placebo after 1 and 5 days of administration. Most participants expressed an overall preference for the fast-dissolving tablet formulation over capsules. All study drugs were well tolerated.

Trends in lithium prescription in Spain from 1985 to 2003.

Lithium use for bipolar disorder has decreased in the United States. We aimed at studying lithium prescription in Spain from 1985 to 2003. Prescription data, expressed in daily defined dose per 1,000 inhabitants per day, were obtained. Lithium prescription increased uninterruptedly from 0.21 to 0.79 DID. The psychiatric reform in Spain and a broader definition of BD during the last decades are possible explanations for this rise.