Impact of Geodemographic Factors on Antibiotic Prescribing for Acute, Uncomplicated Bronchitis or Upper Respiratory Tract Infection.

OBJECTIVE: To assess the impact of geodemographic factors on antibiotic prescribing for adult acute, uncomplicated bronchitis or upper respiratory tract infection. METHODS: A retrospective, observational study of 63,051 single health-system, outpatient discharges with a primary diagnosis of bronchitis or upper respiratory tract infection in 2019. Univariate analyses of prescribing predictors and multivariable stepwise logistic modeling were performed. RESULTS: Patients who were older (aOR 1.02; 95% CI 1.02, 1.02), male (1.10; 1.06, 1.14), black (1.29; 1.22, 1.38), smoked (1.18; 1.14, 1.23), seen in urgent care (1.26; 1.22, 1.31) and living in an area with more owner-occupied housing (1.41; 1.30, 1.53) were more likely to receive antibiotics. Patients who were Asian (0.88; 0.77, 0.99), had Medicare (0.83; 0.78, 0.87), Medicaid (0.84; 0.79, 0.87) or Exchange insurance (0.90; 0.82, 0.98), or seen in the emergency department (0.43; 0.40, 0.46) were less likely to receive antibiotics. Distance from a patient's address and their encounter location did not predict antibiotic prescribing. CONCLUSIONS: Antibiotic prescribing interventions for adult acute bronchitis and upper respiratory tract infections could target patients living in an area with higher socioeconomic status.

Assessing the impact of Geo-demographic factors on antibiotic prescribing for adults with acute, uncomplicated bronchitis.

Context: Acute bronchitis is a common reason patients seek primary care and has predominately viral causes. Yet, antibiotics are often prescribed despite limited evidence of clinical benefit. Interventions targeting antibiotic prescribing for acute bronchitis have reduced prescribing, but rates continued to remain higher than expected. There is also a paucity of data describing variability in antibiotic prescribing and its determinants; specifically, non-clinical, patient-level factors. Identifying non-clinical determinants of antibiotic prescribing for bronchitis could inform better care for these patients in primary care. Objective: To assess the impact of geo-demographic factors on antibiotic prescribing for ambulatory adults with acute, uncomplicated bronchitis. Study design: Cohort study. Setting: Ambulatory clinics, urgent cares and emergency departments within a large, single U.S. health-system. Population studied: Adult patients with a primary diagnosis of bronchitis in 2019. Outcome measures: Predictors of antibiotic prescribing. Results: There were 63,051 unique patients (mean age 48±18 years); 62.7% were female and 78.7% were non-Hispanic Caucasians. Of providers, 66.7% were physicians. Patients who were older (aOR 1.02, 95% CI 1.02-1.02), male (1.06, 1.03-1.10), black (1.21, 1.14-1.29), smoked (1.16, 1.12-1.20), had a nurse practitioner v. physician provider (1.11, 1.06-1.16) or a physician assistant v. physician provider (1.06, 1.01-1.11) were more likely to receive antibiotics. Patients who were Hispanic (0.87, 0.82-0.94), or Asian (0.85, 0.75-0.96) were less likely to receive antibiotics. Additionally, patients who had Medicare (0.78, 0.74-0.82), Medicaid (0.73, 0.69-0.77) or Exchange insurance (0.90, 0.82-0.98) or lived in a U.S. Census Block group with larger number of households without vehicles (0.66, 0.52-0.85) were less likely to receive antibiotics. Those living in an area with more owner-occupied housing were more likely to receive antibiotics (1.39, 1.25-1.53). The distance between a patient's residence and the encounter location did not impact the likelihood of antibiotic prescribing. Conclusions: This study identified antibiotic prescribing disparities for adults with acute bronchitis at the level of the patient, prescriber and the patient residential area. Interventions targeting antibiotic prescribing in this population should consider the role these factors have in prescribing decisions.

Association of Fluoroquinolone Prescribing Rates With Black Box Warnings from the US Food and Drug Administration.

Importance: In 2013 and 2016, the US Food and Drug Administration (FDA) issued warnings and recommended limited use of fluoroquinolones for patients with certain acute conditions. It is not clear how prescribers have responded to these warnings. Objective: To analyze changes in prescribing of fluoroquinolones after the 2013 and 2016 FDA warnings and to examine the physician characteristics associated with these changes. Design, Setting, and Participants: This cross-sectional study used Medicare administrative claims data on Medicare fee-for-service beneficiaries and OneKey data on physicians and their organizations from January 1, 2011, to December 31, 2017. The sample was restricted to outpatient visits for sinusitis, bronchitis, and uncomplicated urinary tract infections. An interrupted time series approach was used to analyze the changes in the prescription rate after each FDA warning. Data analysis was performed between January 1, 2011, and December 31, 2017. Interventions: Two FDA black box warnings released in August 2013 and July 2016. Main Outcomes and Measures: The main outcome was an indicator for fluoroquinolone prescriptions in 3 periods: before the 2013 warning (baseline period), after the 2013 warning but before the 2016 warning (postwarning period 1), and after the 2016 warning (postwarning period 2). Results: The sample comprised 1 238 397 unique patients with a total of 2 720 071 outpatient acute care visits. Of this sample, 848 360 were women (68.5%), and the mean (SD) age was 69.7 (12.6) years. The immediate prescribing levels of fluoroquinolones in postwarning period 1 increased by 3.42 percentage points (95% CI, 3.23-3.62; P < .001) and declined by -0.77 percentage points (95% CI, -1.00 to -0.54; P < .001) in postwarning period 2. The prescribing trend increased by 0.08 percentage points per month (95% CI, 0.08-0.10; P < .001) in postwarning period 1 and 0.06 percentage points per month (95% CI, 0.04-0.08; P < .001) in postwarning period 2. In postwarning period 1, the prescribing levels for physicians who were affiliated with hospitals with a top 10th percentile case mix index vs those without such affiliation decreased by -1.13 percentage points (95% CI, -1.92 to -0.34; P = .005), whereas the levels for primary care physicians declined by -1.34 percentage points (95% CI, -1.78 to -0.88; P < .001) compared with non-primary care physicians in postwarning period 2. Physicians at teaching hospitals were the only ones who showed a decline in prescribing trend in postwarning period 1. Conclusions and Relevance: This cross-sectional study found an overall decline in prescribing of fluoroquinolones after the release of FDA warnings. Understanding the association of physician and organizational characteristics with fluoroquinolone prescribing behavior may ultimately help to identify mechanisms to improve de-adoption.

Reducing Antibiotic Prescribing in Primary Care for Respiratory Illness.

BACKGROUND: One-third of outpatient antibiotic prescriptions for pediatric acute respiratory tract infections (ARTIs) are inappropriate. We evaluated a distance learning program's effectiveness for reducing outpatient antibiotic prescribing for ARTI visits. METHODS: In this stepped-wedge clinical trial run from November 2015 to June 2018, we randomly assigned 19 pediatric practices belonging to the Pediatric Research in Office Settings Network or the NorthShore University HealthSystem to 4 wedges. Visits for acute otitis media, bronchitis, pharyngitis, sinusitis, and upper respiratory infection for children 6 months to <11 years old without recent antibiotic use were included. Clinicians received the intervention as 3 program modules containing online tutorials and webinars on evidence-based communication strategies and antibioti c prescribing, booster video vignettes, and individualized antibiotic prescribing feedback reports over 11 months. The primary outcome was overall antibiotic prescribing rates for all ARTI visits. Mixed-effects logistic regression compared prescribing rates during each program module and a postintervention period to a baseline control period. Odds ratios were converted to adjusted rate ratios (aRRs) for interpretability. RESULTS: Among 72 723 ARTI visits by 29 762 patients, intention-to-treat analyses revealed a 7% decrease in the probability of antibiotic prescribing for ARTI overall between the baseline and postintervention periods (aRR 0.93; 95% confidence interval [CI], 0.90-0.96). Second-line antibiotic prescribing decreased for streptococcal pharyngitis (aRR 0.66; 95% CI, 0.50-0.87) and sinusitis (aRR 0.59; 95% CI, 0.44-0.77) but not for acute otitis media (aRR 0.93; 95% CI, 0.83-1.03). Any antibiotic prescribing decreased for viral ARTIs (aRR 0.60; 95% CI, 0.51-0.70). CONCLUSIONS: This program reduced antibiotic prescribing during outpatient ARTI visits; broader dissemination may be beneficial.

Assessment of the 4-week repeated-dose oral toxicity and genotoxicity of GHX02.

Herbal medicines are widely utilized for disease prevention and health promotion. GHX02 consists of mixtures including Gwaruin (Trichosanthes kirilowii), Haengin (Prunus armeniaca), Hwangryeon (Coptis japonica) and Hwangkeum (Scutellaria baicalensis). It has been purported to have therapeutic effectiveness in cases of severe bronchitis. Non-clinical safety testing comprised a single-dose oral toxicity study and a 28-day repeated-dose oral toxicity study with a 14-day recovery period, and genotoxicity was assessed by a bacterial reverse mutation test, in vitro chromosomal aberration test, in vivo mouse bone marrow micronucleus test and single cell gel electrophoresis assay (comet assay). In the single-dose oral toxicity study, the approximate lethal dosage is estimated to be higher than 5000 mg/kg in rats. Thus, the dosage levels were set at 0, 1250, 2500 and 5000 mg/kg/day in the 28-day repeated-dose oral toxicity study, and 10 male rats and 10 female rats/dose were administered GHX02. No clinical signs of toxicological significance were recorded in any animal during the dosing and the observation period in the single-dose study. The no-observed-adverse-effect level of GHX02 was 5000 mg/kg/day when administered orally for 28 days to male and female Sprague-Dawley rats. Despite increases in the frequencies of cells with numerical chromosomal aberration in the in vitro test, the increases were not considered relevant to the in vivo genetic risk. Except for the increase of in vitro numerical chromosomal aberration, clear negative results were obtained from other genetic toxicity studies.

Appropriate Antibiotic Use for Acute Respiratory Tract Infection in Adults: Advice for High-Value Care From the American College of Physicians and the Centers for Disease Control and Prevention.

BACKGROUND: Acute respiratory tract infection (ARTI) is the most common reason for antibiotic prescription in adults. Antibiotics are often inappropriately prescribed for patients with ARTI. This article presents best practices for antibiotic use in healthy adults (those without chronic lung disease or immunocompromising conditions) presenting with ARTI. METHODS: A narrative literature review of evidence about appropriate antibiotic use for ARTI in adults was conducted. The most recent clinical guidelines from professional societies were complemented by meta-analyses, systematic reviews, and randomized clinical trials. To identify evidence-based articles, the Cochrane Library, PubMed, MEDLINE, and EMBASE were searched through September 2015 using the following Medical Subject Headings terms: "acute bronchitis," "respiratory tract infection," "pharyngitis," "rhinosinusitis," and "the common cold." HIGH-VALUE CARE ADVICE 1: Clinicians should not perform testing or initiate antibiotic therapy in patients with bronchitis unless pneumonia is suspected. HIGH-VALUE CARE ADVICE 2: Clinicians should test patients with symptoms suggestive of group A streptococcal pharyngitis (for example, persistent fevers, anterior cervical adenitis, and tonsillopharyngeal exudates or other appropriate combination of symptoms) by rapid antigen detection test and/or culture for group A Streptococcus. Clinicians should treat patients with antibiotics only if they have confirmed streptococcal pharyngitis. HIGH-VALUE CARE ADVICE 3: Clinicians should reserve antibiotic treatment for acute rhinosinusitis for patients with persistent symptoms for more than 10 days, onset of severe symptoms or signs of high fever (>39 °C) and purulent nasal discharge or facial pain lasting for at least 3 consecutive days, or onset of worsening symptoms following a typical viral illness that lasted 5 days that was initially improving (double sickening). HIGH-VALUE CARE ADVICE 4: Clinicians should not prescribe antibiotics for patients with the common cold.

Cost-Effectiveness of Decision Support Strategies in Acute Bronchitis.

BACKGROUND: A recent clinical trial suggests that printed (PDS) and computer decision support (CDS) interventions are safe and effective in reducing antibiotic use in acute bronchitis relative to usual care (UC). OBJECTIVE: Our aim was to evaluate the cost-effectiveness of decision support interventions in reducing antibiotic use in acute bronchitis. DESIGN: We conducted a clinical trial-based cost-effectiveness analysis comparing UC, PDS and CDS for management of acute bronchitis. We assumed a societal perspective, 5-year program duration and 30-day time horizon. PATIENTS: The U.S. population aged 13-64 years presenting with acute bronchitis in the ambulatory setting. INTERVENTIONS: Printed and computer decision support interventions relative to usual care. MAIN MEASURES: Cost per antibiotic prescription safely avoided. KEY RESULTS: In the base case, PDS dominated UC and CDS, with lesser total costs (PDS: $2,574, UC: $2,768, CDS: $2,805) and fewer antibiotic prescriptions (PDS: 3.79, UC: 4.60, CDS: 3.95) per patient over 5 years. In one-way sensitivity analyses, PDS dominated UC across all parameter values, except when antibiotics reduced work loss by ≥ 1.9 days or the probability of hospitalization within 30 days was ≥ 0.9 % in PDS (base case: 0.2 %) or ≤ 0.4 % in UC (base case: 1.0 %). The dominance of PDS over CDS was sensitive both to probability of hospitalization and plausible variation in the adjusted odds of antibiotic use in both strategies. CONCLUSIONS: A PDS strategy to reduce antibiotic use in acute bronchitis is less costly and more effective than both UC and CDS strategies, although results were sensitive to variation in probability of hospitalization and the adjusted odds of antibiotic use. This simple, low-cost, safe, and effective intervention would be an economically reasonable component of a multi-component approach to address antibiotic overuse in acute bronchitis.

Antibiotic therapy for ventilator-associated tracheobronchitis: a standard of care to reduce pneumonia, morbidity and costs?

PURPOSE OF REVIEW: The present review draws our attention to ventilator-associated tracheobronchitis (VAT) as a distinct clinical entity that has been associated with progression to ventilator-associated pneumonia (VAP) and worse patient outcomes. In contrast to VAP, which has been extensively investigated for over the past 30 years, most VAT studies have been conducted in the past decade. There are ample data which demonstrate that VAT may progress to VAP, have more ventilator days, and have longer ICU stay that may translate into higher healthcare costs. RECENT FINDINGS: The article focuses on the diagnostic criteria for VAT, causative agents, and studies analyzing associations between VAT and patient outcomes in relation to early, appropriate intravenous, and/or aerosolized antibiotic therapy. Aerosolized antibiotic treatment delivered by improved device technology is a novel approach that has proved to be effective for the treatment and eradication of multidrug-resistant bacterial pathogens. Aerosolized antibiotics are effective in decreasing the use of systemic antibiotics, reducing bacterial resistance, and may also facilitate clinical resolution of infection. SUMMARY: Evidence presented in this review supports treatment of VAT with early and appropriate antibiotic therapy as a standard of care to reduce VAP, ventilator days, and duration of ICU stay in high-risk patient population.

The cost-effectiveness of OM-85 in managing respiratory tract infections in China.

OBJECTIVES: To demonstrate the health economic impact of OM-85, a bacterial lysates based immunostimulant, for its approved indications in China. METHODS: A cost-effectiveness decision tree model was constructed comparing OM-85 with the best supportive care/placebo therapy for managing the acute exacerbation of chronic bronchitis and rhinosinusitis in the Chinese population. Clinical efficacy and adverse events (AE) data were included in the model based on a thorough literature review. All localized direct treatment costs, including drug cost, AE costs, and medical treatment costs for underlining diseases were included from a Chinese third party payer perspective. A Key Opinion Leaders (KOL) survey was conducted with 20 senior physicians specialized in respiratory, ENT, allergy, and immunology fields from tertiary hospitals in Beijing, Shanghai, Guangzhou, Hangzhou, Shenyang, and Wuhan to validate the local treatment costs. Incremental cost-effectiveness ratio (ICER) was calculated based on the above efficacy and cost information. RESULTS: OM-85 is a cost-effective therapy when compared with placebo (standard care). OM-85 can treat/prevent one additional full episode exacerbation of chronic bronchitis and one additional full episode exacerbation of rhinosinusitis with only additional costs of RMB 653 and RMB 1182.84, respectively. In comparison, each acute exacerbation of chronic bronchitis will cost RMB 4510.10, and each acute exacerbation of rhinosinuisitis will cost RMB 1807.21 in a Chinese clinical management setting. One-way sensitivity analyses were performed and the ICER result was demonstrated to be consistent. CONCLUSIONS: OM 85 reduces acute exacerbations among patients with chronic bronchitis and chronic rhinosinusitis when compared with Placebo (standard care). From a Chinese payer perspective, OM 85 is a cost-effective therapy in the clinical management of both chronic bronchitis and rhinosinusitis in the adult population.

Assessment of the effect of pharmacotherapy in common cold/acute bronchitis - the Bronchitis Severity Scale (BSS).

BACKGROUND: Acute bronchitis (AB) is a highly contagious infection of the airways, presenting mostly in connection with common cold (CC). There is a high variance in duration and course of symptoms which, sooner or later, also may disappear spontaneously and change during the course of the disease. Therefore, assessment of treatment outcome is difficult. METHODS: Composite outcome measures are commonly used to examine the effects of pharmacotherapy in complex diseases. We discuss the features of the Bronchitis Severity Scale (BSS) on the basis of the available literature. RESULTS: For the BSS the five most important symptoms of AB are rated by the patient and the physician. Since its introduction in 1996, the BSS has been used in many clinical trials evaluating treatment effects of AB. Its score correlates well with clinical findings. As thorough validation analyses revealed, this applies even more to the BSS subscales "cough domain" and "sputum domain". CONCLUSION: The validated BSS appears to be a reliable tool to assess therapeutic effects in CC/AB. The BSS and its subscales are recommended as outcome measures for future drug trials in CC/AB, but also help physicians to focus their consultation in patients with CC/AB.

HealthPartners' online clinic for simple conditions delivers savings of $88 per episode and high patient approval.

The delivery of health care online is relatively new. However, early indications suggest that it can improve the experience of care for patients and the health of populations, along with reducing per capita health care costs. HealthPartners in Minnesota launched an online clinic called virtuwell in late 2010. After more than 40,000 cases, we report an average $88 lower cost per episode compared with care received in traditional settings, strong indicators of clinical effectiveness, and a 98 percent "would recommend" rating from customers. The possibility of extrapolating such savings to larger volumes of cases is compelling. We suggest a need for regulatory reform, particularly around state-level statutes that create barriers to the expansion of online care delivery, such as those that require clinicians to be located in the same state as the patient and those requiring clinicians to have had a previous face-to-face visit with a patient. Such reforms would encourage further innovation and lead to cost reduction and improvements in access and convenience for consumers throughout the health care system.

Assessment of antibiotic prescribing in Latvian general practitioners.

BACKGROUND: Though general antibiotic consumption data is available, information on the actual patterns of prescribing antibiotics locally is difficult to obtain. An easy to use methodology was designed to assess ambulatory management of infections by Latvian general practitioners (GPs). METHODS: GPs were asked to record data in a patient data collection form for every patient that received antibiotics. Study period - (7 days) one week in November, 2008. Data recorded included the following details: an antibiotic, the prescribed dose, dosing interval, route of administration combined with the demographic factors of the patient and clinical diagnosis based on a pre-defined list. RESULTS: Two hundred forty eight forms out of the 600 (41%) were returned by post. Antibiotics were prescribed in 6.4% (1711/26803) of outpatient consultations. In total, 1763 antibiotics were prescribed during the study period. Ninety seven percent of the patients received monotherapy and only 47 (2.7%) patients were prescribed two antibiotics. The most commonly prescribed antibiotics were amoxicillin (33.9% of prescribed), amoxicillin/clavulanate (18,7%) and clarithromycin (7.6%). The most commonly treated indications were pharyngitis (29.8%), acute bronchitis (25.3%) and rhinosinusitis (10.2%). Pneumonia was mostly treated with amoxicillin/clavulanate (25,7%), amoxicillin (15.7%) and clarithromycin (19.3%). CONCLUSIONS: Methodology employed provided useful additional information on ambulatory practice of prescribing antibiotics and could be used in further assessment studies. Educational interventions should be focused on treatment of acute pharyngitis and bronchitis in children and unnecessary use of quinolones in adults for uncomplicated urinary tract infection.

Cost and clinical consequence of antibiotic non-adherence in acute exacerbations of chronic bronchitis.

OBJECTIVE: To quantify the impact of non-adherence on the clinical effectiveness of antibiotics for acute exacerbations of chronic bronchitis (AECB) and to estimate the economic consequences for Spain, Italy and the United States. METHODS: Standard systematic reviewing procedures were followed to identify randomised controlled clinical trials of antibiotic treatment for acute respiratory tract infection for which adherence was reported. A decision-analytic model was then constructed to evaluate the impact of non-adherence to antibiotic treatment on clinical effectiveness and costs per AECB episode. The model compared the total treatment costs, cure rates and incremental costs per cure for a poor compliance group (PCG) against a good compliance group (GCG). Clinical and resource use estimates were from the published literature and physician surveys. RESULTS: Twenty-five articles met the criteria of the systematic review, although only one reported treatment success by adherence status. The relative risk of clinical effectiveness if non-adherent was 0.75 (95%CI 0.73-0.78). Based on this single study, the model predicted that 16-29% more patients would be cured in the GCG vs. the PCG, and payers would save up to euro122, euro179 and US$141 per AECB episode in Spain, Italy and the United States, respectively. CONCLUSIONS: Non-adherence to antibiotics for AECB may have an impact on clinical effectiveness, which is associated with increased costs.

Inflammatory mechanisms and treatment of obstructive airway diseases with neutrophilic bronchitis.

Obstructive airway diseases such as asthma and chronic obstructive pulmonary disease (COPD) are major global health issues. Although considered as distinct diseases, airway inflammation is a key underlying pathophysiological process in asthma, COPD and bronchiectasis. Persistent neutrophilic airway inflammation (neutrophilic bronchitis) occurs with innate immune activation and is a feature of each of these airway diseases. Little is known about the mechanisms leading to neutrophilic bronchitis and few treatments are effective in reducing neutrophil accumulation in the airways. There is a similar pattern of inflammatory mediator release and toll like receptor 2 expression in asthma, COPD and bronchiectasis. We propose the existence of an active amplification mechanism, an effector arm of the innate immune system, involving toll like receptor 2, operating in persistent neutrophilic bronchitis. Neutrophil persistence in the airways can occur through a number of mechanisms such as impaired apoptosis, efferocytosis and mucus hypersecretion, all of which are impaired in airways disease. Impairment of neutrophil clearance results in a reduced ability to respond to bacterial infection. Persistent activation of airway neutrophils may result in the persistent activation of the innate immune system resulting in further airway insult. Current therapies are limited for the treatment of neutrophilic bronchitis; possible treatments being investigated include theophylline, statins, antagonists of pro-inflammatory cytokines and macrolide antibiotics. Macrolides have shown great promise in their ability to reduce airway inflammation, and can reduce airway neutrophils, levels of CXCL8 and neutrophil proteases in the airways. Studies also show improvements in quality of life and exacerbation rates in airways diseases.

Antimicrobial prescribing for upper respiratory infections and its effect on return visits.

BACKGROUND AND OBJECTIVES: Antibiotic resistance is a growing problem that complicates the treatment of various illnesses. This study analyzes Medicaid encounter data to (1) determine antibiotic prescribing rates for common respiratory tract infections in Oregon and (2) assess the effect of receiving an antibiotic at an index visit on whether there was a return visit within 30 days. METHODS: Subjects included in this study were Medicaid patients in Oregon between 2001--2003 who were enrolled in Medicaid for a full year and were diagnosed with an upper respiratory tract infection, including bronchitis, sinusitis, acute otitis media (AOM), pharyngitis, and upper respiratory infections (URIs). Claims data were analyzed to determine receipt of an antibiotic within 3 days of the initial visit and if there was a return visit within 30 days. RESULTS: During 2001--2003, the proportion of patients receiving antibiotics for bronchitis and sinusitis decreased, from 70% to 61%, and from 78% to 74%, respectively, while antibiotic prescribing for AOM, URI, and pharyngitis changed little. After controlling for age, gender, race/ethnicity, Medicaid plan type, and location, we determined that patients who had received antibiotics during the index visit for AOM, URI, and pharyngitis were more likely to return with a respiratory tract infection during the subsequent 30 days than patients who did not receive antibiotics. CONCLUSIONS: Antibiotic prescribing among Medicaid patients in Oregon has decreased. Receiving an antibiotic does not decrease the rate of subsequent return visits.

Healthcare use and costs in patients with chronic bronchitis initiating maintenance therapy with fluticasone/salmeterol vs other inhaled maintenance therapies.

OBJECTIVE: To compare risk of hospitalization or emergency department (ED) visit and healthcare costs in patients with chronic bronchitis initiating inhaled maintenance therapy with fluticasone propionate/salmeterol 250/50 mcg combination (FSC) versus other inhaled maintenance therapies. DESIGN AND METHODS: This retrospective cohort study assessed 9,217 patients from the PharMetrics administrative claims database enrolled from July 1997 to January 2005. Study subjects were persons with medical claims with diagnoses of chronic bronchitis (ICD-9-CM 491.xx) who also had pharmacy claims for FSC, salmeterol (SAL), inhaled corticosteroid (ICS), ipratropium (IPR), or ipratropium/albuterol combination (IAC). Persons with <12 months of continuous eligibility after the first prescription for initial maintenance therapy ("index date") were excluded as were those receiving fluticasone propionate/salmeterol 100/50 mcg or 500/50 mcg (not indicated for patients with chronic bronchitis). For remaining persons, time to first hospitalization or ED visit during follow-up was compared for those receiving FSC versus other therapies using Cox proportional hazards regression. Healthcare costs during the first 12 months of follow-up were analyzed using generalized linear model regression. RESULTS: Receipt of FSC as initial inhaled maintenance therapy for chronic bronchitis (n = 1361) was associated with 41% lower risk of COPD-related hospitalization or ED visit compared with IPR (n < 1316) (p < 0.001). Adjusted costs of COPD-related hospitalization/ED visit were $507 (95% CI $218-$1083) less with FSC than IPR. However, patients receiving FSC had $261 (95% CI $205-$322) higher COPD-related pharmacy costs than those receiving IPR. Total COPD-related costs were $90 lower with FSC than IPR although this difference was not significant (95% CI $330-$443). Compliance, as measured by medication possession ratio, was 12% greater with FSC compared with IPR (p < 0.05). Comparisons of FSC with IAC yielded generally similar results. The limitations of the study are similar to those of other observational studies of secondary data regarding potential misclassification and omitted variable bias and residual confounding. CONCLUSIONS: In persons with chronic bronchitis, initial maintenance therapy with FSC 250/50 mcg was associated with improved outcomes versus ipratropium-based therapy and although FSC was associated with greater pharmacy costs, it did not significantly increase total costs of COPD-related care.

EPs 7630 improves acute bronchitic symptoms and shortens time to remission. Results of a randomised, double-blind, placebo-controlled, multicentre trial.

Acute bronchitis commonly associated with cough is predominantly caused by viral infections. The burden on health-care systems and society is enormous. A randomised, placebo-controlled, multicentre clinical trial to investigate the efficacy and safety of a liquid herbal drug preparation from the roots of Pelargonium sidoides (EPs 7630) was conducted in 217 adult outpatients with acute bronchitis. The primary efficacy variable was the bronchitis symptom score (BSS) ranging from 0 to 20. Primary data of this study were already published in 2007. Now, we present further analyses of these already published data combined with new results in order to focus on both the most important features of acute bronchitis and pharmaco-economic aspects of the disease. The BSS decreased by 7.6 +/- 2.2 (mean +/- SD) points for the active treatment group and 5.3 +/- 3.2 points for placebo (p < 0.0001). As compared with placebo, a marked improvement has been shown for EPs 7630 for all disease symptoms (cough, sputum, rales, dyspnoe, pain on coughing, hoarseness, headache, fatigue, fever, limb pain) categorised in severity classes by the patient. Especially strong antitussive and "anti-fatigue" effects with an early onset during treatment were observed. Patients in the EPs 7630 group were sooner able to work and to a lesser extent confined to bed. In both treatment groups, 3 x 30 drops of the trial medication administered for 7 days were well tolerated. No serious adverse events have been observed. In conclusion, EPs 7630 is superior to placebo in the treatment of acute bronchitis and leads to faster remission of bronchitis related symptoms.

Is co-morbidity taken into account in the antibiotic management of elderly patients with acute bronchitis and COPD exacerbations?

BACKGROUND: Guidelines on acute lower respiratory tract infections recommend restrictive use of antibiotics, however, in patients with relevant co-morbid conditions treatment with antibiotics should be considered. Presently, it is unknown whether GPs adhere to these guidelines and target antibiotic treatment more often at patients with risk-elevating conditions. OBJECTIVES: We assessed whether in elderly primary care patients with acute bronchitis or exacerbations of chronic pulmonary disease (COPD), antibiotics are more often prescribed to patients with risk-elevating co-morbid conditions. METHODS: Using the Utrecht GP research database, we analysed 2643 episodes in patients of 65 years of age or older with a GP-diagnosed acute bronchitis or exacerbation of COPD. Multivariable logistic regression analysis was applied to determine independent determinants of antibiotic use. RESULTS: Antibiotic prescribing rates were high in both acute bronchitis (84%) and in exacerbations of COPD (53%). In acute bronchitis, only age was an independent determinant of antibiotic use [odds ratio (OR) 1.03, 95% confidence interval (CI) 1.003-1.048], whereas in exacerbations of COPD antibiotics were more often prescribed to male patients (OR 1.3, 95% CI 1.0-1.5), patients with diabetes (OR 1.7, 95% CI 1.1-2.4) and heart failure (OR 1.3, 95% CI 1.0-1.7). CONCLUSION: Dutch GPs prescribe antibiotics in the majority of elderly patients with acute bronchitis and in half of the episodes of exacerbations of COPD. Tailoring their antibiotic treatment according to the presence or absence of high-risk co-morbid conditions could help GPs in improving antibiotic use in patients with respiratory tract infections in primary care.

[Risk factors for increased cost of exacerbations of chronic bronchitis and chronic obstructive pulmonary disease]. / Factores de riesgo de elevado coste de las agudizaciones de la bronquitis crónica y la EPOC.

OBJECTIVE: To identify what variables characterizing the patients, exacerbations, and treatment of chronic bronchitis and chronic obstructive pulmonary disease (COPD) are associated with a higher direct health cost. METHOD: Observational pharmacoeconomic study of exacerbations of chronic bronchitis and COPD (of probable bacterial etiology, defined as Anthonisen types I or II). Direct health costs were assessed during 30 days of follow-up. Logistic regression was employed for statistical analysis, with calculation of the adjusted odds ratios (OR). An exacerbation cost greater than 150 euros was defined as the dependent variable. RESULTS: Data on 1164 patients were collected by 252 physicians. Pharmacoeconomic data were complete in 947 patients (82.6%). In the first 30 days, 206 sought medical attention because of unsatisfactory response to treatment (21.8%), 69 (7.3%) attended the emergency room, and 22 (2.3%) were admitted to hospital. Overall, 101 exacerbations (10.7%) were classified as high cost (> 150 euros). Continuous oxygen therapy (OR = 7.58) and previous hospitalization (OR = 2.6) were associated with high-cost exacerbations, whereas diagnosis of chronic bronchitis (OR = 0.41) and treatment of the exacerbation with moxifloxacin or amoxicillin-clavulanic acid as opposed to clarithromycin (OR = 0.38) were associated with low-cost exacerbations. CONCLUSION: Treatment failure was reported for 21.8% of the patients with exacerbations of chronic bronchitis and COPD. Repeated medical visits and requests for complementary tests were the main factors responsible for increased cost. Variables associated with high-cost exacerbations were continuous oxygen therapy, previous hospitalization, and treatment with clarithromycin as opposed to moxifloxacin or amoxicillin-clavulanic acid.