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1.
Int J Chron Obstruct Pulmon Dis ; 17: 1409-1421, 2022.
Article in English | MEDLINE | ID: mdl-35761954

ABSTRACT

Background: Patients with mild chronic obstructive pulmonary disease (COPD) account for more than half of the total COPD population but are often undiagnosed and sparsely studied. This real-world, longitudinal study compared the socioeconomic burden, clinical characteristics and treatment patterns in patients with mild COPD and age- and gender-matched controls. Patients and methods: Our population included mild COPD patients (forced expiratory volume in one second ≥80% of predicted value) and reference controls from 52 Swedish primary care centres over 15 years (2000-2014). We linked electronic medical record (EMR) data to Sweden's National Health Registries. The outcomes analyzed were socioeconomic status including annual income from work, presence of comorbidities and the use of medications. Results: 844 patients with mild COPD were included in this study and matched with 844 reference controls. Compared with the reference controls, mild COPD patients had a significantly lower annual income from work (mean difference, men: 12,559€ and women: 7143€) and were significantly less likely to be married or employed. The presence of comorbidities, including cardiovascular disease, anxiety and depression (only women) was significantly higher in mild COPD patients. The use of medications, such as proton pump inhibitors, antidepressants, central painkillers and sleep medications, was significantly higher in the mild COPD group. Conclusion: Mild COPD presents a considerable socioeconomic and clinical burden compared with reference controls The findings suggest that COPD constitutes a condition that influences health status even in mild disease clearly demanding an increased need for early detection and treatment.


Subject(s)
Pulmonary Disease, Chronic Obstructive , Female , Forced Expiratory Volume , Humans , Longitudinal Studies , Male , Pulmonary Disease, Chronic Obstructive/diagnosis , Pulmonary Disease, Chronic Obstructive/drug therapy , Pulmonary Disease, Chronic Obstructive/epidemiology , Retrospective Studies , Social Class , Sweden/epidemiology
2.
Article in English | MEDLINE | ID: mdl-33776429

ABSTRACT

PURPOSE: The aim of this study was to assess the association between exacerbation frequency and clinical and economic outcomes in patients with COPD. PATIENTS AND METHODS: Electronic medical record data linked to National Health Registries were collected from COPD patients at 52 Swedish primary care centers (2000-2014). The outcomes analyzed were exacerbation rate, mortality, COPD treatments, lung function and healthcare costs during the follow-up period. Based on the exacerbation rate two years before index date, the patients were initially classified into three groups, either 0, 1 or ≥2 exacerbations per year. After the index date, the classification into exacerbation groups was updated each year based on the exacerbation rate during the last year of follow-up. A sensitivity analysis was conducted excluding patients with asthma diagnosis from the analysis. RESULTS: In total 18,586 COPD patients were analyzed. A majority of the patients (60-70%) who either have had no exacerbation or frequent exacerbations (≥2/year) during the pre-index period remained in their group (ie, with 0 or ≥2 annual exacerbations) during up to 11 years of follow-up. Compared with having no exacerbation, mortality was higher in patients having 1 (HR; 2.06 [1.93-2.20]) and ≥2 (4.58 [4.33-4.84]) exacerbations at any time during the follow-up. Lung function decline was more rapid in patients with frequent exacerbations and there was an almost linear relationship between exacerbations frequency and mortality. Total healthcare costs were higher in the frequent exacerbation group (≥2/year) than in patients with no or one exacerbation annually (p<0.0001 for both). The results did not differ from the main analysis after exclusion of patients with a concurrent asthma diagnosis. CONCLUSION: In addition to faster lung function decline and increased mortality, frequent exacerbations in COPD patients imply a significant economic burden.


Subject(s)
Pulmonary Disease, Chronic Obstructive , Disease Progression , Health Care Costs , Humans , Pulmonary Disease, Chronic Obstructive/diagnosis , Pulmonary Disease, Chronic Obstructive/epidemiology , Pulmonary Disease, Chronic Obstructive/therapy , Sweden/epidemiology , Time Factors
3.
Eur Respir J ; 57(2)2021 02.
Article in English | MEDLINE | ID: mdl-32972982

ABSTRACT

The effect of inhaled corticosteroids (ICS) on the risk of osteoporosis and fracture in patients with chronic obstructive pulmonary disease (COPD) remains uncertain. The aim of this study was to assess this risk in patients with COPD.Electronic medical record data linked to National Health Registries were collected from COPD patients and matched reference controls at 52 Swedish primary care centres from 2000 to 2014. The outcomes analysed were the effect of ICS on all fractures, fractures typically related to osteoporosis, recorded osteoporosis diagnosis, prescriptions of drugs for osteoporosis and a combined measure of any osteoporosis-related event. The COPD patients were stratified by the level of ICS exposure.A total of 9651 patients with COPD and 59 454 matched reference controls were analysed. During the follow-up, 19.9% of COPD patients had at least one osteoporosis-related event compared with 12.9% of reference controls (p<0.0001). Multivariate analysis in the COPD population demonstrated a dose-effect relationship, with high-dose ICS being significantly associated with any osteoporosis-related event (risk ratio 1.52 (95% CI 1.24-1.62)), while the corresponding estimate for low-dose ICS was 1.27 (95% CI 1.13-1.56) compared with COPD patients not using ICS. A similar dose-related adverse effect was found for all four of the specific osteoporosis-related events: all fractures, fractures typically related to osteoporosis, prescriptions of drugs for osteoporosis and diagnosis of osteoporosis.We conclude that patients with COPD have a greater risk of bone fractures and osteoporosis, and high-dose ICS use increased this risk further.


Subject(s)
Fractures, Bone , Osteoporosis , Pulmonary Disease, Chronic Obstructive , Administration, Inhalation , Adrenal Cortex Hormones/adverse effects , Fractures, Bone/chemically induced , Fractures, Bone/epidemiology , Humans , Osteoporosis/chemically induced , Osteoporosis/complications , Osteoporosis/drug therapy , Pulmonary Disease, Chronic Obstructive/complications , Pulmonary Disease, Chronic Obstructive/drug therapy , Pulmonary Disease, Chronic Obstructive/epidemiology , Sweden/epidemiology
4.
NPJ Prim Care Respir Med ; 30(1): 47, 2020 10 20.
Article in English | MEDLINE | ID: mdl-33082331

ABSTRACT

This study reports the association of ICS use and the risk of type 2 diabetes mellitus (T2DM) in Swedish patients with COPD using data from real-world, primary care settings. A total of 7078 patients with COPD were included in this analysis and the 5-year cumulative incidence rate per 100,000 person years was 1506.9. The yearly incidence rate per 100,000 person years ranged from 850 to 1919. Use of ICS especially at a high dose in patients with COPD was related to an increased risk of T2DM.


Subject(s)
Adrenal Cortex Hormones/adverse effects , Bronchodilator Agents/adverse effects , Diabetes Mellitus, Type 2/chemically induced , Pulmonary Disease, Chronic Obstructive/drug therapy , Administration, Inhalation , Adrenal Cortex Hormones/administration & dosage , Adrenal Cortex Hormones/therapeutic use , Aged , Bronchodilator Agents/administration & dosage , Bronchodilator Agents/therapeutic use , Diabetes Mellitus, Type 2/epidemiology , Female , Humans , Incidence , Male , Risk Factors , Sweden/epidemiology
5.
Ups J Med Sci ; 125(4): 316-324, 2020 Nov.
Article in English | MEDLINE | ID: mdl-32696698

ABSTRACT

BACKGROUND: The electronic medical record (EMR) offers unique possibilities for clinical research, but some important patient attributes are not readily available due to its unstructured properties. We applied text mining using machine learning to enable automatic classification of unstructured information on smoking status from Swedish EMR data. METHODS: Data on patients' smoking status from EMRs were used to develop 32 different predictive models that were trained using Weka, changing sentence frequency, classifier type, tokenization, and attribute selection in a database of 85,000 classified sentences. The models were evaluated using F-score and accuracy based on out-of-sample test data including 8500 sentences. The error weight matrix was used to select the best model, assigning a weight to each type of misclassification and applying it to the model confusion matrices. The best performing model was then compared to a rule-based method. RESULTS: The best performing model was based on the Support Vector Machine (SVM) Sequential Minimal Optimization (SMO) classifier using a combination of unigrams and bigrams as tokens. Sentence frequency and attributes selection did not improve model performance. SMO achieved 98.14% accuracy and 0.981 F-score versus 79.32% and 0.756 for the rule-based model. CONCLUSION: A model using machine-learning algorithms to automatically classify patients' smoking status was successfully developed. Such algorithms may enable automatic assessment of smoking status and other unstructured data directly from EMRs without manual classification of complete case notes.


Subject(s)
Electronic Health Records , Machine Learning , Natural Language Processing , Smoking , Tobacco Use Disorder/diagnosis , Algorithms , Automation , Bayes Theorem , Data Mining , False Positive Reactions , Humans , Medical Informatics , Observer Variation , Pattern Recognition, Automated , ROC Curve , Reproducibility of Results , Research Design , Software , Support Vector Machine , Sweden/epidemiology , Tobacco Use Disorder/epidemiology
6.
NPJ Prim Care Respir Med ; 29(1): 45, 2019 12 10.
Article in English | MEDLINE | ID: mdl-31822681

ABSTRACT

The present study aimed to generate real-world evidence regarding gender differences among chronic obstructive pulmonary disease (COPD) patients, especially as regards the diagnosis and outcomes in order to identify areas for improvement and management and optimize the associated healthcare resource allocation. ARCTIC is a large, real-world, retrospective cohort study conducted in Swedish COPD patients and a matched reference population from 52 primary care centers in 2000-2014. The incidence of COPD, prevalence of asthma and other comorbidities, risk of exacerbations, mortality rate, COPD drug prescriptions, and healthcare resource utilization were analyzed. In total, 17,479 patients with COPD were included in the study. During the study period, COPD was more frequent among women (53.8%) and women with COPD experienced more exacerbations vs. men (6.66 vs. 4.66). However, the overall mortality rate was higher in men compared with women (45% vs. 38%), but no difference for mortality due to COPD was seen between genders over the study period. Women seemed to have a greater susceptibility to asthma, fractures, osteoporosis, rheumatoid arthritis, rhinitis, depression, and anxiety, but appeared less likely to have diabetes, kidney diseases, and cardiovascular diseases. Furthermore, women had a greater risk of COPD-related hospitalization and were likely to receive a significantly higher number of COPD drug prescriptions compared with men. These results support the need to reduce disease burden among women with COPD and highlight the role of healthcare professionals in primary care who should consider all these parameters in order to properly diagnose and treat women with COPD.


Subject(s)
Forecasting , Glucocorticoids/administration & dosage , Pulmonary Disease, Chronic Obstructive/epidemiology , Aged , Drug Administration Routes , Female , Follow-Up Studies , Humans , Incidence , Male , Middle Aged , Prognosis , Pulmonary Disease, Chronic Obstructive/drug therapy , Retrospective Studies , Sex Distribution , Sex Factors , Survival Rate/trends , Sweden/epidemiology
7.
Scand J Urol ; 53(5): 312-318, 2019 Oct.
Article in English | MEDLINE | ID: mdl-31815592

ABSTRACT

Objective: This retrospective, single-centre, non-interventional, registry-based study evaluated patients with metastatic castration-resistant prostate cancer (mCRPC) treated with enzalutamide in daily clinical practice at Skåne University Hospital, Malmö, Sweden.Materials and methods: Registry data were reviewed for patients treated with enzalutamide pre- or post-chemotherapy initiated between December 2013 and June 2017. The primary endpoint was overall survival (OS) in post-chemotherapy patients. Secondary endpoints were enzalutamide treatment duration in the pre- and post-chemotherapy setting. This study was approved by the Lund regional Ethics Review Board (Dnr:2017/716) and is registered with ClinicalTrials.gov (NCT03328364).Results: A total of 102 pre-chemotherapy and 98 post-chemotherapy patients were included. Median age was higher in the pre- than in the post-chemotherapy group (77 vs 72 years, respectively). Median OS in post-chemotherapy patients from initiation of enzalutamide until death from any cause was 14.3 months [95% confidence interval (CI) = 11.00-18.20]. Median treatment duration was 13.8 months (95% CI = 11.4-20.2) and 7.6 months (95% CI = 6.3-10.2) for pre- and post-chemotherapy patients, respectively.Conclusion: Enzalutamide can be used to effectively treat mCRPC patients in daily clinical settings, despite the patients being older and less healthy than those enrolled in the previous randomised, clinical registration studies.


Subject(s)
Phenylthiohydantoin/analogs & derivatives , Prostatic Neoplasms, Castration-Resistant/drug therapy , Prostatic Neoplasms, Castration-Resistant/mortality , Registries , Aged , Aged, 80 and over , Benzamides , Duration of Therapy , Humans , Male , Middle Aged , Nitriles , Phenylthiohydantoin/therapeutic use , Prostatic Neoplasms, Castration-Resistant/secondary , Retrospective Studies , Survival Rate , Sweden
8.
Int J Chron Obstruct Pulmon Dis ; 14: 995-1008, 2019.
Article in English | MEDLINE | ID: mdl-31190785

ABSTRACT

Purpose: Assess the clinical and economic consequences associated with an early versus late diagnosis in patients with COPD. Patients and methods: In a retrospective, observational cohort study, electronic medical record data (2000-2014) were collected from Swedish primary care patients with COPD. COPD indicators (pneumonia, other respiratory diseases, oral corticosteroids, antibiotics for respiratory infections, prescribed drugs for respiratory symptoms, lung function measurement) registered prior to diagnosis were applied to categorize patients into those receiving early (2 or less indicators) or late diagnosis (3 or more indicators registered >90 days preceding a COPD diagnosis). Outcome measures included annual rate of and time to first exacerbation, mortality risk, prevalence of comorbidities and health care utilization. Results: More patients with late diagnosis (n=8827) than with early diagnosis (n=3870) had a recent comorbid diagnosis of asthma (22.0% vs 3.9%; P<0.0001). Compared with early diagnosis, patients with late diagnosis had a higher exacerbation rate (hazard ratio [HR] 1.89, 95% confidence interval [CI]: 1.83-1.96; P<0.0001) and shorter time to first exacerbation (HR 1.61, 95% CI: 1.54-1.69; P<0.0001). Mortality was not different between groups overall but higher for late versus early diagnosis, after excluding patients with past asthma diagnosis (HR 1.10, 95% CI: 1.02-1.18; P=0.0095). Late diagnosis was also associated with higher direct costs than early diagnosis. Conclusion: Late COPD diagnosis is associated with higher exacerbation rate and increased comorbidities and costs compared with early diagnosis. The study highlights the need for accurate diagnosis of COPD in primary care in order to reduce exacerbations and the economic burden of COPD.


Subject(s)
Health Care Costs , Primary Health Care/economics , Pulmonary Disease, Chronic Obstructive/diagnosis , Pulmonary Disease, Chronic Obstructive/economics , Aged , Comorbidity , Disease Progression , Early Diagnosis , Electronic Health Records , Female , Health Status , Humans , Male , Predictive Value of Tests , Prognosis , Pulmonary Disease, Chronic Obstructive/drug therapy , Pulmonary Disease, Chronic Obstructive/mortality , Retrospective Studies , Risk Factors , Sweden/epidemiology , Time Factors
9.
NPJ Prim Care Respir Med ; 28(1): 33, 2018 09 10.
Article in English | MEDLINE | ID: mdl-30202023

ABSTRACT

This study aimed to generate real-world evidence to assess the burden of comorbidities in COPD patients, to effectively manage these patients and optimize the associated healthcare resource allocation. ARCTIC is a large, real-world, retrospective cohort study conducted in Swedish COPD patients using electronic medical record data collected between 2000 and 2014. These patients were studied for prevalence of various comorbidities and for association of these comorbidities with exacerbations, mortality, and healthcare costs compared with an age-, sex-, and comorbidities-matched non-COPD reference population. A total of 17,479 patients with COPD were compared with 84,514 non-COPD reference population. A significantly higher prevalence of various comorbidities was observed in COPD patients 2 years post-diagnosis vs. reference population, with the highest percentage increase observed for cardiovascular diseases (81.8% vs. 30.7%). Among the selected comorbidities, lung cancer was relatively more prevalent in COPD patients vs. reference population (relative risk, RR = 5.97, p < 0.0001). Ischemic heart disease, hypertension, depression, anxiety, sleep disorders, osteoporosis, osteoarthritis, and asthma caused increased mortality rates in COPD patients. Comorbidities that were observed to be significantly associated with increased number of severe exacerbations in COPD patients included heart failure, ischemic heart disease, depression/anxiety, sleep disorders, osteoporosis, lung cancer, and stroke. The cumulative healthcare costs associated with comorbidities over 2 years after the index date were observed to be significantly higher in COPD patients (€27,692) vs. reference population (€5141) (p < 0.0001). The data support the need for patient-centered treatment strategies and targeted healthcare resource allocation to reduce the humanistic and economic burden associated with COPD comorbidities.


Subject(s)
Cost of Illness , Pulmonary Disease, Chronic Obstructive/complications , Cohort Studies , Disease Progression , Electronic Health Records , Female , Health Care Costs , Humans , Male , Pulmonary Disease, Chronic Obstructive/economics , Pulmonary Disease, Chronic Obstructive/mortality , Pulmonary Disease, Chronic Obstructive/therapy , Retrospective Studies , Sweden
10.
Respir Res ; 19(1): 172, 2018 Sep 10.
Article in English | MEDLINE | ID: mdl-30200965

ABSTRACT

BACKGROUND: Inhaled corticosteroids (ICS) are associated with an increased risk of pneumonia in patients with chronic obstructive pulmonary disease (COPD). Other factors such as severity of airflow limitation and concurrent asthma may further raise the possibility of developing pneumonia. This study assessed the risk of pneumonia associated with ICS in patients with COPD. METHODS: Electronic Medical Record data linked to National Health Registries were collected from COPD patients and matched reference controls in 52 Swedish primary care centers (2000-2014). Levels of ICS treatment (high, low, no ICS) and associated comorbidities were assessed. Patients were categorized by airflow limitation severity. RESULTS: A total of 6623 patients with COPD and 48,566 controls were analyzed. Patients with COPD had a more than 4-fold increase in pneumonia versus reference controls (hazard ratio [HR] 4.76, 95% confidence interval [CI]: 4.48-5.06). ICS use increased the risk of pneumonia by 20-30% in patients with COPD with forced expiratory volume in 1 s ≥ 50% versus patients not using ICS. Asthma was an independent risk factor for pneumonia in the COPD population. Multivariate analysis identified independent predictors of pneumonia in the overall population. The highest risk of pneumonia was associated with high dose ICS (HR 1.41, 95% CI: 1.23-1.62). CONCLUSIONS: Patients with COPD have a greater risk of pneumonia versus reference controls; ICS use and concurrent asthma increased the risk of pneumonia further.


Subject(s)
Electronic Health Records/trends , Pneumonia/diagnosis , Pneumonia/epidemiology , Pulmonary Disease, Chronic Obstructive/diagnosis , Pulmonary Disease, Chronic Obstructive/epidemiology , Registries , Aged , Cohort Studies , Female , Humans , Longitudinal Studies , Male , Middle Aged , Primary Health Care/trends , Retrospective Studies , Risk Factors , Sweden/epidemiology
11.
Article in English | MEDLINE | ID: mdl-29391785

ABSTRACT

Background: We assessed direct and indirect costs associated with COPD in Sweden and examined how these costs vary across time, age, and disease stage in a cohort of patients with COPD and matched controls in a real-world, primary care (PC) setting. Patients and methods: Data from electronic medical records linked to the mandatory national health registers were collected for COPD patients and a matched reference population in 52 PC centers from 2000 to 2014. Direct health care costs (drug, outpatient or inpatient, PC, both COPD related and not COPD related) and indirect health care costs (loss of income, absenteeism, loss of productivity) were assessed. Results: A total of 17,479 patients with COPD and 84,514 reference controls were analyzed. During 2013, direct costs were considerably higher among the COPD patient population (€13,179) versus the reference population (€2,716), largely due to hospital nights unrelated to COPD. Direct costs increased with increasing disease severity and increasing age and were driven by higher respiratory drug costs and non-COPD-related hospital nights. Indirect costs (~€28,000 per patient) were the largest economic burden in COPD patients of working age during 2013. Conclusion: As non-COPD-related hospital nights represent the largest direct cost, management of comorbidities in COPD would offer clinical benefits and relieve the financial burden of disease.


Subject(s)
Cost of Illness , Health Care Costs , Health Expenditures , Primary Health Care/economics , Pulmonary Disease, Chronic Obstructive/economics , Pulmonary Disease, Chronic Obstructive/therapy , Absenteeism , Age Factors , Aged , Female , Health Care Costs/trends , Health Expenditures/trends , Humans , Income , Male , Middle Aged , Models, Economic , Primary Health Care/trends , Pulmonary Disease, Chronic Obstructive/diagnosis , Pulmonary Disease, Chronic Obstructive/epidemiology , Registries , Retrospective Studies , Sick Leave/economics , Sweden , Time Factors , Treatment Outcome
12.
Int J Cancer ; 139(12): 2722-2729, 2016 Dec 15.
Article in English | MEDLINE | ID: mdl-27563839

ABSTRACT

Cutaneous malignant melanoma (CMM) incidence is increasing globally, making a thorough understanding of the disease and its outcomes essential for optimizing care even more urgent. In this population-based, retrospective study, we investigated stage-specific survival and recurrence/progression rates of CMM among patients diagnosed in Stockholm County Council during 2005-2012, before the wide introduction of targeted therapy. A total of 3,554 CMM patients from the Stockholm Melanoma Register were included. Information on comorbidities, progression, death, and treatments was obtained from nationwide registers and hospital electronic medical records. Unadjusted 5-year survival varied from 91.4% for stage I to 24.6% for stage IV patients. Stage, age and gender were predictors of survival, with gender an independent predictor of survival for stages IA and IIA. 74.6% of patients remained recurrence/progression-free during follow-up, with 5-year recurrence/progression-free survival rates varying from 85.3% to 12.9% among stages I and IV patients, respectively. In addition to stage, male gender, and age, circulatory system comorbidities increased the risk for recurrence/progression. No statistically significant differences in progression rate for operated and non-operated patients could be detected, possibly due to high rate (98.9%) of surgery. Our estimates of survival and recurrence rates are consistent with historical and global expectations and can serve as a baseline to gauge population-level improvements with use of novel melanoma treatments.


Subject(s)
Melanoma/mortality , Melanoma/pathology , Adult , Aged , Disease Progression , Female , Follow-Up Studies , Humans , Male , Melanoma/epidemiology , Middle Aged , Neoplasm Recurrence, Local , Neoplasm Staging , Population Surveillance , Prognosis , Proportional Hazards Models , Registries , Retrospective Studies , Skin Neoplasms , Survival Rate , Sweden/epidemiology , Melanoma, Cutaneous Malignant
13.
Diabetes Ther ; 7(2): 321-33, 2016 Jun.
Article in English | MEDLINE | ID: mdl-27216947

ABSTRACT

INTRODUCTION: The aim of the present study was to use real-world data from Swedish primary-care and national registries to understand clinical outcomes in patients with Type 2 diabetes (T2D) treated with liraglutide in clinical practice, and to compare with data from those treated with sitagliptin. METHODS: This was a non-interventional, retrospective study conducted between February 2014 and September 2014 using T2D patient data from Swedish primary-care centers and national healthcare registries. The primary objective was to assess the effectiveness of liraglutide in control of glycemia and body weight in clinical practice (stage 1). The secondary objective was to compare the clinical effectiveness of liraglutide with sitagliptin on glycemic control and body weight in clinical practice in a propensity-score-matched population (stage 2). RESULTS: In stage 1 (n = 402), 39.4% of patients treated with liraglutide achieved ≥1.0% (10.9 mmol/mol) reduction in glycated hemoglobin (HbA1c) after 180 days of treatment and 54.9% achieved the target HbA1c of <7.0% (53.0 mmol/mol). Moreover, compared with baseline, 22.5% of patients treated with liraglutide achieved both ≥1.0% reduction in HbA1c and ≥3.0% reduction in body weight. In stage 2, a significantly greater proportion of patients receiving liraglutide (n = 180) than sitagliptin (n = 208) achieved ≥1.0% reduction in HbA1c [52.9% vs 33.5%, respectively (P = 0.0002)]. Mean body-weight loss was also significantly greater in patients receiving liraglutide vs sitagliptin [-3.5 vs -1.3 kg, respectively (P < 0.0001)]. CONCLUSION: This study provides real-world evidence from Sweden corroborating previous clinical trials that demonstrate greater efficacy of liraglutide over sitagliptin on glycemic control and body-weight reduction in patients with T2D. FUNDING: Novo Nordisk A/S. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT02077946.

14.
Thorax ; 69(2): 130-6, 2014 Feb.
Article in English | MEDLINE | ID: mdl-24092567

ABSTRACT

BACKGROUND: In mild asthma exercise-induced bronchoconstriction (EIB) is usually treated with inhaled short-acting ß2 agonists (SABAs) on demand. OBJECTIVE: The hypothesis was that a combination of budesonide and formoterol on demand diminishes EIB equally to regular inhalation of budesonide and is more effective than terbutaline inhaled on demand. METHODS: Sixty-six patients with asthma (>12 years of age) with verified EIB were randomised to terbutaline (0.5 mg) on demand, regular budesonide (400 µg) and terbutaline (0.5 mg) on demand, or a combination of budesonide (200 µg) + formoterol (6 µg) on demand in a 6-week, double-blind, parallel-group study (ClinicalTrials.gov identifier: NCT00989833). The patients were instructed to perform three to four working sessions per week. The main outcome was EIB 24 h after the last dosing of study medication. RESULTS: After 6 weeks of treatment with regular budesonide or budesonide+formoterol on demand the maximum post-exercise forced expiratory volume in 1 s fall, 24 h after the last medication, was 6.6% (mean; 95% CI -10.3 to -3.0) and 5.4% (-8.9 to -1.8) smaller, respectively. This effect was superior to inhalation of terbutaline on demand (+1.5%; -2.1 to +5.1). The total budesonide dose was approximately 2.5 times lower in the budesonide+formoterol group than in the regular budesonide group. The need for extra medication was similar in the three groups. CONCLUSIONS: The combination of budesonide and formoterol on demand improves asthma control by reducing EIB in the same order of magnitude as regular budesonide treatment despite a substantially lower total steroid dose. Both these treatments were superior to terbutaline on demand, which did not alter the bronchial response to exercise. The results question the recommendation of prescribing SABAs as the only treatment for EIB in mild asthma.


Subject(s)
Asthma, Exercise-Induced/prevention & control , Bronchodilator Agents/administration & dosage , Budesonide/administration & dosage , Ethanolamines/administration & dosage , Administration, Inhalation , Adolescent , Adrenergic beta-2 Receptor Agonists/administration & dosage , Adrenergic beta-2 Receptor Agonists/adverse effects , Adrenergic beta-2 Receptor Agonists/therapeutic use , Adult , Asthma, Exercise-Induced/physiopathology , Bronchodilator Agents/adverse effects , Bronchodilator Agents/therapeutic use , Budesonide/adverse effects , Budesonide/therapeutic use , Double-Blind Method , Drug Administration Schedule , Drug Therapy, Combination , Ethanolamines/adverse effects , Ethanolamines/therapeutic use , Exercise Test/methods , Female , Forced Expiratory Volume/drug effects , Formoterol Fumarate , Glucocorticoids/administration & dosage , Glucocorticoids/adverse effects , Glucocorticoids/therapeutic use , Humans , Male , Terbutaline/administration & dosage , Terbutaline/adverse effects , Terbutaline/therapeutic use , Vital Capacity/drug effects , Young Adult
15.
J Affect Disord ; 151(1): 209-19, 2013 Oct.
Article in English | MEDLINE | ID: mdl-23810357

ABSTRACT

BACKGROUND: Patients with treatment-resistant major depressive disorder (MDD) remain a common clinical challenge. METHODS: This 6-week, randomised, open-label, rater-blinded trial evaluated once-daily extended-release quetiapine fumarate (quetiapine XR; 300 mg/day) as add-on to ongoing antidepressant and quetiapine XR monotherapy (300 mg/day) compared with add-on lithium (0.6-1.2 mmol/L) in patients with treatment-resistant MDD. Primary efficacy measure: change in Montgomery Åsberg Depression Rating Scale (MADRS) total score from randomisation to week 6 with a pre-specified non-inferiority limit of 3 points on the MADRS. RESULTS: At week 6, both add-on quetiapine XR (n=231) and quetiapine XR monotherapy (n=228) were non-inferior to add-on lithium (n=229); least squares means (LSM) differences (97.5% CI) in MADRS total score changes were -2.32 (-4.6, -0.05) and -0.97 (-3.24, 1.31), respectively. LSM MADRS total score change was numerically greater at day 4 for both quetiapine XR groups (add-on and monotherapy; p<0.01) compared with add-on lithium. At week 6, the differences between groups for the secondary endpoints of MADRS response (≥ 50% reduction in total score), MADRS remission (total score ≤ 10, add-on quetiapine XR only) and Clinical Global Impressions ('much'/'very much' improved) were numerically similar. Overall tolerability was consistent with the known profiles of both treatments. LIMITATIONS: Limitations included the open-label study design (although MADRS and laboratory measurements were performed by treatment-blinded raters) and relatively short study duration with no assessments in the continuation phase. CONCLUSIONS: Add-on quetiapine XR (300 mg/day) and quetiapine XR monotherapy (300 mg/day) are non-inferior to add-on lithium in the management of patients with treatment-resistant MDD.


Subject(s)
Antidepressive Agents/administration & dosage , Antipsychotic Agents/administration & dosage , Depressive Disorder, Major/drug therapy , Depressive Disorder, Treatment-Resistant/drug therapy , Dibenzothiazepines/administration & dosage , Lithium Compounds/administration & dosage , Adolescent , Adult , Aged , Antidepressive Agents/therapeutic use , Antipsychotic Agents/therapeutic use , Delayed-Action Preparations , Dibenzothiazepines/therapeutic use , Drug Therapy, Combination , Female , Humans , Lithium/administration & dosage , Lithium/therapeutic use , Lithium Compounds/therapeutic use , Male , Middle Aged , Psychiatric Status Rating Scales , Quetiapine Fumarate , Treatment Outcome , Young Adult
16.
BMJ ; 346: f3306, 2013 May 29.
Article in English | MEDLINE | ID: mdl-23719639

ABSTRACT

OBJECTIVE: To investigate the occurrence of pneumonia and pneumonia related events in patients with chronic obstructive pulmonary disease (COPD) treated with two different fixed combinations of inhaled corticosteroid/long acting ß2 agonist. DESIGN: Observational retrospective pairwise cohort study matched (1:1) for propensity score. SETTING: Primary care medical records data linked to Swedish hospital, drug, and cause of death registry data for years 1999-2009. PARTICIPANTS: Patients with COPD diagnosed by a physician and prescriptions of either budesonide/formoterol or fluticasone/salmeterol. MAIN OUTCOME MEASURES: Yearly pneumonia event rates, admission to hospital related to pneumonia, and mortality. RESULTS: 9893 patients were eligible for matching (2738 in the fluticasone/salmeterol group; 7155 in the budesonide/formoterol group), yielding two matched cohorts of 2734 patients each. In these patients, 2115 (39%) had at least one recorded episode of pneumonia during the study period, with 2746 episodes recorded during 19,170 patient years of follow up. Compared with budesonide/formoterol, rate of pneumonia and admission to hospital were higher in patients treated with fluticasone/salmeterol: rate ratio 1.73 (95% confidence interval 1.57 to 1.90; P<0.001) and 1.74 (1.56 to 1.94; P<0.001), respectively. The pneumonia event rate per 100 patient years for fluticasone/salmeterol versus budesonide/formoterol was 11.0 (10.4 to 11.8) versus 6.4 (6.0 to 6.9) and the rate of admission to hospital was 7.4 (6.9 to 8.0) versus 4.3 (3.9 to 4.6). The mean duration of admissions related to pneumonia was similar for both groups, but mortality related to pneumonia was higher in the fluticasone/salmeterol group (97 deaths) than in the budesonide/formoterol group (52 deaths) (hazard ratio 1.76, 1.22 to 2.53; P=0.003). All cause mortality did not differ between the treatments (1.08, 0.93 to 1.14; P=0.59). CONCLUSIONS: There is an intra-class difference between fixed combinations of inhaled corticosteroid/long acting ß2 agonist with regard to the risk of pneumonia and pneumonia related events in the treatment of patients with COPD. TRIAL REGISTRATION: Clinical Trials.gov NCT01146392.


Subject(s)
Adrenergic beta-2 Receptor Agonists/adverse effects , Albuterol/analogs & derivatives , Androstadienes/adverse effects , Budesonide/adverse effects , Ethanolamines/adverse effects , Glucocorticoids/adverse effects , Pneumonia/chemically induced , Pneumonia/mortality , Pulmonary Disease, Chronic Obstructive/drug therapy , Pulmonary Disease, Chronic Obstructive/mortality , Adrenergic beta-2 Receptor Agonists/therapeutic use , Albuterol/adverse effects , Albuterol/therapeutic use , Androstadienes/therapeutic use , Budesonide/therapeutic use , Cohort Studies , Ethanolamines/therapeutic use , Fluticasone , Formoterol Fumarate , Glucocorticoids/therapeutic use , Humans , Salmeterol Xinafoate
17.
Int J Soc Psychiatry ; 59(2): 137-46, 2013 Mar.
Article in English | MEDLINE | ID: mdl-22100570

ABSTRACT

BACKGROUND: There is a lack of studies of the size of burden associated with informal care giving in psychosis. AIMS: To evaluate the objective and subjective burden of informal care giving to patients with psychoses, and to compare a diary and recall method for assessments of objective burden. METHOD: Patients and their informal caregivers were recruited from nine Swedish psychiatric outpatient centres. Subjective burden was assessed at inclusion using the CarerQoL and COPE index scales. The objective burden (time and money spent) was assessed by the caregivers daily using diaries over four weeks and by recall at the end of weeks 1 and 2. RESULTS: One-hundred and seven patients (53% females; mean age 43 ± 11) and 118 informal caregivers (67%; 58 ± 15 years) were recruited. Informal caregivers spent 22.5 hours/week and about 14% of their gross income on care-related activities. The time spent was underestimated by two to 20 hours when assessed by recall than by daily diary records. The most prominent aspects of the subjective burden were mental problems. CONCLUSION: Despite a substantial amount of time and money spent on care giving, the informal caregivers perceived the mental aspects of burden as the most troublesome. The informal caregiver burden is considerable and should be taken into account when evaluating effects of health care provided to patients with psychoses.


Subject(s)
Caregivers , Cost of Illness , Patient Care , Process Assessment, Health Care , Psychotic Disorders/economics , Stress, Psychological , Adaptation, Psychological , Adult , Aged , Ambulatory Care/economics , Ambulatory Care/methods , Ambulatory Care/psychology , Caregivers/economics , Caregivers/psychology , Female , Humans , Male , Medical Records/standards , Medical Records/statistics & numerical data , Middle Aged , Patient Care/economics , Patient Care/psychology , Process Assessment, Health Care/economics , Process Assessment, Health Care/methods , Process Assessment, Health Care/standards , Stress, Psychological/etiology , Stress, Psychological/psychology , Surveys and Questionnaires , Sweden , Time Factors
18.
Hum Psychopharmacol ; 27(5): 492-8, 2012 Sep.
Article in English | MEDLINE | ID: mdl-22996616

ABSTRACT

OBJECTIVES: The atypical antipsychotic quetiapine is a first-line treatment for schizophrenia. This non-interventional study (NCT01212575) evaluated the clinical use of its two formulations, extended release (XR) and immediate release (IR), in outpatients with schizophrenia spectrum disorder. METHODS: Patients who had received at least one dose of quetiapine XR and/or IR were included. A dosage ≥400 mg/day was defined as antipsychotic. Medical records data were collected retrospectively. RESULTS: Of 186 enrolled patients, 99 (53%) and 87 (47%) received quetiapine XR and IR, respectively. Use in antipsychotic dosage was seen for 89% XR versus 63% IR patients (mean daily dose ≥400 mg/day; p < 0.0001). 75% XR and 53% IR patients used dosages ≥600 mg/day (p = 0.0019). Quetiapine XR was used at higher mean daily dosages than IR (748 vs 566 mg/day; p = 0.006). Forty-three patients (23%) used both formulations concomitantly; 55 patients (30%) used either XR or IR. Quetiapine IR was used as-needed in 44 patients (23%); one patient used XR as-needed. CONCLUSIONS: Quetiapine XR was used more often in higher (antipsychotic) dosages; quetiapine IR more frequently on an as-needed administration basis. Concomitant use was seen. These findings probably reflect the different profiles of XR/IR and advocate the need for both formulations to offer treatment choice.


Subject(s)
Antipsychotic Agents/therapeutic use , Dibenzothiazepines/therapeutic use , Schizophrenia/drug therapy , Adult , Antipsychotic Agents/administration & dosage , Delayed-Action Preparations , Denmark , Dibenzothiazepines/administration & dosage , Dose-Response Relationship, Drug , Female , Humans , Male , Middle Aged , Outpatients , Quetiapine Fumarate , Retrospective Studies , Young Adult
19.
APMIS ; 120(6): 433-40, 2012 Jun.
Article in English | MEDLINE | ID: mdl-22583355

ABSTRACT

We report the results of a re-examination of a series of 57 biopsies from 50 patients with the clinical diagnosis of hidradenitis suppurativa, submitted to the Department of Pathology at the University Hospital of Northern Norway, Tromsø, Norway. The biopsy material came from hospitals and physicians all over northern Norway in the years 2000-2007. All tissue material was resectioned and stained with the immunohistochemical reagent, cytokeratin (AE1/AE3/PKC26), and that made it possible to divide the material into two different disease categories: (1) 36 biopsies from 30 cases had tissue inflammation after rupture of keratin-rich epidermal cysts, which we call 'horny cell inflammation', followed by extensive cutaneous thrombi and infarcts, and (2) 21 biopsies from 20 cases had 'apocrinitis' defined here as an inflammatory destruction of apocrine skin glands, and partly of close eccrine glands. The two disease populations differed: the patients with a diagnosis of horny cell inflammation were younger and mainly women; those with a diagnosis of apocrinitis, as defined here, were older, men and women equally represented.


Subject(s)
Hidradenitis Suppurativa/pathology , Adolescent , Adult , Age Factors , Apocrine Glands/metabolism , Apocrine Glands/pathology , Biopsy , Child , Female , Hidradenitis Suppurativa/metabolism , Humans , Immunohistochemistry/methods , Male , Middle Aged , Sex Factors , Young Adult
20.
Prim Care Respir J ; 21(2): 159-66, 2012 Jun.
Article in English | MEDLINE | ID: mdl-22270480

ABSTRACT

BACKGROUND: The importance of identifying chronic obstructive pulmonary disease (COPD) at an early stage is recognised. Improved and easily accessible identification of individuals at risk of COPD in primary care is needed to select patients for spirometry more accurately. AIMS: To explore whether use of a mini-spirometer can predict a diagnosis of COPD in patients at risk of COPD in primary care, and to assess its cost-effectiveness in detecting patients with COPD. METHODS: Primary care patients aged 45-85 years with a smoking history of >15 pack-years were selected. Data were collected on the Clinical COPD Questionnaire (CCQ), Medical Research Council (MRC) dyspnoea scale and smoking habits. Lung function (forced expiratory volume in 1 and 6 s; FEV1 and FEV6, respectively) was measured by mini-spirometer (copd-6), followed by diagnostic standard spirometry (COPD diagnosis post-bronchodilation ratio of FEV1 to forced vital capacity (FVC) <0.7). Time consumed was recorded. Univariate logistic regression and receiver operating characteristic (ROC) curves were used. RESULTS: A total of 305 patients (57% females) of mean (SD) age 61.2 (8.4) years, mean (SD) total CCQ 1.0 (0.8) and mean (SD) MRC 0.8 (0.8) were recruited from 21 centres. COPD was diagnosed in 77 patients (25.2%) by standard diagnostic spirometry. Using the copd-6 device, mean (SD) FEV1/FEV6 was 68 (8)% in patients with COPD and 78 (10)% in patients without COPD. Sensitivity and specificity at a FEV1/FEV6 cut-off of 73% were 79.2% and 80.3%, respectively. The area under the ROC curve was 0.84. Screening with the copd-6 device significantly predicted COPD. Gender, CCQ, and MRC were not found to predict COPD. CONCLUSIONS: Using the copd-6 as a pre-screening device, the rate of COPD diagnoses by standard diagnostic spirometry increased from 25.2% to 79.2%. Although the sensitivity and specificity of the copd-6 could be improved, it might be an important device for prescreening of COPD in primary care and may reduce the number of unnecessary spirometric tests performed.


Subject(s)
Pulmonary Disease, Chronic Obstructive/diagnosis , Spirometry , Aged , Aged, 80 and over , Cost-Benefit Analysis , Forced Expiratory Volume , Health Care Costs , Humans , Logistic Models , Male , Middle Aged , Pulmonary Disease, Chronic Obstructive/economics , Pulmonary Disease, Chronic Obstructive/physiopathology , ROC Curve , Risk Factors , Smoking/adverse effects , Spirometry/economics , Spirometry/methods , Vital Capacity
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