Management of chronic obstructive pulmonary disease associated with chronic bronchitis with inhaled fluticasone propionate/salmeterol (ADVAIR DISKUS) 250/50: results of a patient experience trial.
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CONTEXT: Chronic obstructive pulmonary disease (COPD) is recognized as a major healthcare problem in the United States and around the world. OBJECTIVE: This survey regarding initial experience in patients with COPD collected feedback about newly initiated therapy with fluticasone propionate/salmeterol (FSC; ADVAIR DISKUS). DESIGN: Three telephone surveys were conducted; Survey 1 prior to initiating therapy with FSC 250/50, and Surveys 2 and 3 at 2 weeks and 30 days after initiating therapy with FSC 250/50, respectively. SETTING: One thousand primary care physicians recruited outpatients into the trial. PATIENTS: Patients were either newly diagnosed with COPD associated with chronic bronchitis or were still experiencing breathing difficulties on an anticholinergic medication. INTERVENTIONS: Patients initiated FSC 250/50 and received a 1-month supply of FSC 250/50 with an albuterol inhaler for rescue use. MAIN OUTCOME MEASURES: Outcome measures were patient perceptions of satisfaction, compliance, and convenience and changes in breathing on 1 (negative) to 9 (positive) point scales. RESULTS: Five hundred sixteen patients completed all 3 surveys. The mean age was 61 years, 63% were female, and 62% had been diagnosed with COPD associated with chronic bronchitis for 3 years or less (Table 1). CONCLUSION: Patients reported high satisfaction, compliance, and convenience with FSC 250/50 within 2 weeks of initiating therapy, all maintained over the trial period. Additionally, patients had positive changes in breathing, including improvements in the ability to breathe upon awakening in the morning. (+info)
Treating acute exacerbations of chronic bronchitis and community-acquired pneumonia: how effective are respiratory fluoroquinolones?
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OBJECTIVE: To provide family physicians with a review of evidence supporting fluoroquinolone therapy for defined patient populations with acute exacerbations of chronic bronchitis (AECB) and community-acquired pneumonia (CAP). QUALITY OF EVIDENCE: A MEDLINE search found surveillance studies, randomized controlled trials, outcome studies, and expert consensus opinion. Descriptions of patient populations for which fluoroquinolone therapy is recommended are based on level I and level III evidence. MAIN MESSAGE: A growing body of evidence supports fluoroquinolones as first-choice agents for treatment of AECB or CAP patients with comorbidity or a recent history of antibiotic use. Judicious and targeted therapy using fluoroquinolones among patients at risk of infections of the lower respiratory tract should contribute to improved clinical outcomes and broader health care savings. CONCLUSION: Current data show clinical utility and cost-effectiveness of fluoroquinolones in lower respiratory tract infections. The most recently issued AECB and CAP guidelines now recommend these antimicrobial agents as first-choice agents for specific patient populations. (+info)
Macrolides, quinolones and amoxicillin/clavulanate for chronic bronchitis: a meta-analysis.
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The comparative effectiveness and safety of macrolides, quinolones and amoxicillin/clavulanate (A/C) for the treatment of patients with acute bacterial exacerbation of chronic bronchitis (ABECB) was evaluated in the present study. PubMed, Current Contents and the Cochrane Central Register of Controlled Trials were searched to identify relevant randomised controlled trials (RCTs). In total, 19 RCTs (20 comparisons) were included in the present analysis. There was no difference regarding treatment success in intention-to-treat and clinically evaluable patients between macrolides and quinolones, A/C and quinolones or A/C and macrolides. The treatment success in microbiologically evaluable patients was lower for macrolides compared with quinolones (odds ratio (OR) 0.47, 95% confidence interval (CI) 0.31-0.69). Fewer quinolone-recipients experienced a recurrence of ABECB after resolution of the initial episode compared with macrolide-recipients during the 26-week period following therapy. Adverse effects in general were similar between macrolides and quinolones. Administration of A/C was associated with more adverse effects (mainly diarrhoea) than quinolones (OR 1.36, 95% CI 1.01-1.85). Macrolides, quinolones and amoxicillin/clavulanate may be considered equivalent for the treatment of patients with an acute bacterial exacerbation of chronic bronchitis in terms of short-term effectiveness. Quinolones are associated with better microbiological success and fewer recurrences of acute bacterial exacerbation of chronic bronchitis than macrolides, while amoxicillin/clavulanate is associated with more adverse effects than both comparators. (+info)
Chronic bronchitis and chronic obstructive pulmonary disease. The Finnish Action Programme, interim report.
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The Finnish National Prevention and Treatment Programme for Chronic Bronchitis and COPD, launched in 1998, has, to date, been running for 6 years (2003). The goals of this action programme were to reduce the incidence of COPD and the number of moderate and severe cases of the disease, and to reduce both the number of days of hospitalisation and treatment costs. A prevalent implementation of over 250 information and training events started. Health centres and pharmacies appointed a person in charge of COPD patients. In order to improve the cooperation between primary and specialised care, two thirds of hospital districts created local COPD treatment chains. The early diagnosis of COPD by spirometric examination was activated during the programme. Number of health centres with available spirometric services increased to 95%. Before the start of the programme, approximately 5-9% of the adult population had COPD. During the whole programme, the proportion of male and female smokers decreased from 30% to 26% and from 20% to 19%, respectively. The total number of hospitalisation periods and days due to COPD decreased by 15% and 18%, respectively. Both the number of pensioners and daily sickness days due to COPD also decreased by 18%. Registered COPD induced deaths remained at their previous levels during the monitoring period, i.e. around 1000 deaths out of 5.2 millions annually. The measures recommended by the programme have been widely introduced but they need to be still more effective. (+info)
Chronic bronchitis among nonsmoking farm women in the agricultural health study.
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OBJECTIVE: The purpose of this study was to examine agricultural risk factors for chronic bronchitis among nonsmoking farm women. METHODS: We used self-reported enrollment data from the 21,541 nonsmoking women in the Agricultural Health Study to evaluate occupational risk factors for prevalent chronic bronchitis among farm women. Odds ratios (ORs) for chronic bronchitis for occupational exposures were adjusted for age, state, and related agricultural exposures. RESULTS: Applying manure and driving combines were independently associated with chronic bronchitis. Off-farm job exposures associated with chronic bronchitis were organic dusts, asbestos, gasoline, and solvents. Five pesticides were associated with chronic bronchitis after multivariate adjustment and sensitivity analyses: dichlorvos (OR=1.63, 95% CI=1.01, 2.61), DDT (OR=1.67, 95% CI=1.13, 2.47), cyanazine (OR=1.88, 95% CI=1.00, 3.54), paraquat (OR=1.91, 95% CI=1.02, 3.55), and methyl bromide (OR=1.82, 95% CI=1.02, 3.24). CONCLUSION: Pesticides as well as grain and dust exposures were associated with chronic bronchitis among nonsmoking farm women. (+info)
Vectorcardiographic assessment of acute hypoxia effects in pulmonary hypertension due to chronic bronchitis.
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OBJECTIVE: Vectorcardiography (VCG) QRS loop area is thought to reflect hemodynamic abnormalities in cardiac lesions. The aim of the present study was to evaluate the response of VCG QRS loop area and intrapulmonary flow (PF) to acute hypoxia in patients with chronic bronchitis (CB) and pulmonary arterial hypertension (PAH). METHODS: One-hundred and eleven patients (mean age 45.0+/-1.0 years) with chronic bronchitis (CB) and 43 comparable healthy subjects were included into the study. Diagnosis of CB was based on clinical, radiological, spirography and oximetry investigations. Cardiac catheterization, 2-dimensional and Doppler echocardiography, VCG by Mcfee-Parungao (VCG) and electrocardiography were used to establish PAH and right ventricular hypertrophy (RVH). Pulmonary flow was studied using impedance plethysmography (IP). Vectorcardiography, IP and Doppler echocardiography were also performed to assess the changes in QRS loop area, PF and mean pulmonary artery pressure (PAPm) in response to acute hypoxia (inhalation of hypoxic mixture 16% O2 for 5-10 minutes) in 21 patients with CB and 7 healthy subjects. RESULTS: At baseline, patients with CB were characterized by pulmonary ventilation disturbances of mixed and obstructive types. Among patients who underwent acute hypoxia test PAPm was increased in 10 patients (29.2+/-2.1 mmHg) (Group 1), while in the latter 11 patients the PAPm was within normal values (16.5+/-1.8 mmHg) (Group 2). The IP showed reduction of PF and increase in pulmonary vascular resistance. Patients with CB react to the acute hypoxic test by increase in PAPm by 32% (absolute increase up to 22.5+/-0.7 mm Hg) in group 2 and by 38.9% (absolute increase up to 39.7+/-2.1 mmHg) in patients of group 1. There was a displacement of PF on IP to the upper and middle zones of lungs during acute hypoxia: PF in the upper and middle zones of the right lung increased by 35.6% and 32.5% in patients of group 2; while in patients of group 1 the PF increased by 33.5% and 4.8% at the same zones. On VCG QRS loop area was enhanced significantly in horizontal plane by 68% (p<0.05), but more significant changes were recorded in the anterior direction (by 75%, p<0.02) during acute hypoxia. CONCLUSION: Thus, in patients with early stages of PAH, changes in PF and QRS loop area during acute hypoxia may reflect the compensatory redistribution of pulmonary flow in response to hypoxia. (+info)
Telithromycin: the perils of hasty adoption and persistence of off-label prescribing.
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BACKGROUND: Telithromycin (Ketek) was approved in April 2004 for the treatment of acute bacterial exacerbations of chronic bronchitis (ABECB), bacterial sinusitis, and community-acquired pneumonia. The approval of telithromycin was controversial due to trial irregularities, noninferiority study designs, and use of foreign safety data. Safety concerns involving hepatotoxicity, myasthenia gravis exacerbation, and visual disturbances were increasingly documented in the literature after approval. On February 12, 2007, the U.S. Food and Drug Administration (FDA) removed the bacterial sinusitis and ABECB indications and strengthened safety warnings for telithromycin. OBJECTIVE: To (1) assess the prevalence and distribution of on-label telithromycin utilization before and after the revisions of the product label and (2) assess the association of pivotal events in the life cycle of telithromycin with its use as reflected in pharmacy and medical claims. METHODS: Using retrospective administrative medical and pharmacy claims from a large midwestern commercial insurer with an eligible membership of 1.8 million members, individuals with a telithromycin claim during January 1, 2007, through April 13, 2007, were identified. Their medical claims within 30 days prior to or on the initial telithromycin claim were analyzed for the presence of an on-label diagnosis code. Monthly telithromycin and clarithromycin claim totals per million members from January 2004 through March 2007 were calculated. Claim totals were plotted to identify utilization trends in relation to the FDA health advisory for telithromycin on January 20, 2006, and the telithromycin label changes on February 12, 2007. RESULTS: The medical diagnosis analysis consisted of 507 members with 1 or more medical claims with dates of service within 30 days of at least 1 pharmacy claim for telithromycin. Using the original approved telithromycin indications, 52.3% (256 of 507) of telithromycin use was on-label. The most common on-label diagnoses were sinusitis (33.9%) and bronchitis (14.4%). A diagnosis of pneumonia was present for 3.9% of telithromycin utilizers. After the February 12, 2007, label change limiting telithromycin to community-acquired pneumonia, on-label use was 6.7% (12 of 179) of utilizers. Telithromycin claims were first detected in August 2004 and overtook the clarithromycin rate of 729 claims per million members in January 2005, reaching a peak rate of 940 claims per million members in January 2006. Telithromycin monthly claims remained higher than clarithromycin until April 2006, 3 months after the liver toxicity health advisory. In comparison with January 2006, the January 2007 telithromycin claims were 186 claims per million members, a decrease of 80%. CONCLUSION: Despite revised FDA indications and safety warnings, fewer than 1 in 15 active telithromycin users have a medical claim consistent with the only currently approved indication (pneumonia). Pharmacy claims for telithromycin dropped substantially following reports of severe hepatotoxicity and strengthened safety warnings. The high prevalence of telithromycin off-label use despite hepatotoxicity and other safety risks is cause for continued concern. (+info)
Impact of flu on hospital admissions during 4 flu seasons in Spain, 2000-2004.
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BACKGROUND: Seasonal flu epidemics in the European region cause high numbers of cases and deaths. Flu-associated mortality has been estimated but morbidity studies are necessary to understand the burden of disease in the population. Our objective was to estimate the excess hospital admissions in Spain of diseases associated with influenza during four epidemic influenza periods (2000-2004). METHODS: Hospital discharge registers containing pneumonia, chronic bronchitis, heart failure and flu from all public hospitals in Spain were reviewed for the years 2000 to 2004. Epidemic periods were defined by data from the Sentinel Surveillance System. Excess hospitalisations were calculated as the difference between the average number of weekly hospitalisations/100,000 in epidemic and non-epidemic periods. Flu epidemics were defined for seasons 2001/2002, 2002/2003, 2003/2004. RESULTS: A(H3N2) was the dominant circulating serotype in 2001/2002 and 2003/2004. Negligible excess hospitalisations were observed during the 2002/2003 epidemic where A(H1N1) was circulating. During 2000/2001, flu activity remained below threshold levels and therefore no epidemic period was defined. In two epidemic periods studied a delay between the peak of the influenza epidemic and the peak of hospitalisations was observed. During flu epidemics with A(H3N2), excess hospitalisations were higher in men and in persons <5 and >64 years higher than 10 per 100,000. Pneumonia accounted for 70% of all flu associated hospitalisations followed by chronic bronchitis. No excess flu-specific hospitalisations were recorded during all seasons. CONCLUSION: Flu epidemics have an impact on hospital morbidity in Spain. Further studies that include other variables, such as temperature and humidity, are necessary and will deepen our understanding of the role of each factor during flu epidemics and their relation with morbidity. (+info)