Characterization of exacerbations of chronic bronchitis and COPD in Europe. The GIANT study

Servei de Pneumologia Institut Clínic del Tòrax Hospital Clínic, Barcelona, Spain.
Therapeutic Advances in Respiratory Disease (Impact Factor: 1.95). 10/2009; 3(6):267-77. DOI: 10.1177/1753465809352791
Source: PubMed


The GIANT study collected information on patients with acute exacerbations of chronic bronchitis (AECB) and chronic obstructive pulmonary disease (COPD) and the effect of treatment with moxifloxacin.
AECB history, concomitant diseases, moxifloxacin treatment, concomitant medication, clinical symptoms and adverse events were recorded. A questionnaire at the end of treatment recorded the impact on patients' daily lives.
Among 9225 patients from eight European countries, marked variation was seen in characteristics including age, smoking history and type of exacerbation. Spirometry use was more common among chest physicians (66.7%) than GPs (15.5%). Patients with Anthonisen type 1 and 2 exacerbations had more frequent exacerbations and these patients experienced a greater impact on daily activities compared with patients with type 3 episodes. Patient symptoms improved with moxifloxacin treatment after a mean (SD) of 3.4 (1.8) days, allowing return to normal daily activities after 5.4 (4.4) days and with full recovery taking 6.5 (3.1) days.
Characteristics of patients with AECB and acute exacerbations of COPD differ among European countries. Spirometry is under-used, particularly in primary care and antibiotic treatment does not always follow current guidelines. Results confirm the efficacy of moxifloxacin in the treatment of AECB in real-life conditions.

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Available from: Marc Miravitlles, Jul 26, 2014
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    • "Physicians rated the tolerability of moxifloxacin as ‘very good or good’ in approximately 98% of patients, similar to the rate (97%) reported in the observational study by Miravitlles et al. [29]. Incidences of TEAEs and drug-related adverse events were low. "
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    ABSTRACT: BACKGROUND: Acute exacerbations of chronic bronchitis (AECB), including chronic obstructive pulmonary disease (AECOPD), represent a substantial patient burden. Few data exist on outpatient antibiotic management for AECB/AECOPD in Eastern/South Eastern Europe, in particular on the use of moxifloxacin (Avelox(R)), although moxifloxacin is widely approved in this region based on evidence from international clinical studies. METHODS: AVANTI (AVelox(R) in Acute Exacerbations of chroNic bronchiTIs) was a prospective, observational study conducted in eight Eastern European countries in patients > 35 years with AECB/AECOPD to whom moxifloxacin was prescribed. In addition to safety and efficacy outcomes, data on risk factors and the impact of exacerbation on daily life were collected. RESULTS: In the efficacy population (N = 2536), chronic bronchitis had been prevalent for > 10 years in 31.4% of patients and 66.0% of patients had concomitant COPD. Almost half the patients had never smoked, in contrast to data from Western Europe and the USA, where only one-quarter of COPD patients are non-smokers. The mean number of exacerbations in the last 12 months was 2.7 and 26.3% of patients had been hospitalized at least once for exacerbation. Physician compliance with the recommended moxifloxacin dose (400 mg once daily) was 99.6%. The mean duration of moxifloxacin therapy for the current exacerbation (Anthonisen type I or II in 83.1%; predominantly type I) was 6.4 +/- 1.9 days. Symptom improvement was reported after a mean of 3.4 +/- 1.4 days. After 5 days, 93.2% of patients reported improvement and, in total, 93.5% of patients were symptom-free after 10 days. In the safety population (N = 2672), 57 (2.3%) patients had treatment-emergent adverse events (TEAEs) and 4 (0.15%) had serious TEAEs; no deaths occurred. These results are in line with the known safety profile of moxifloxacin. CONCLUSIONS: A significant number of patients in this observational study had risk factors for poor outcome, justifying use of moxifloxacin. The safety profile of moxifloxacin and its value as an antibiotic treatment were confirmed. Physicians complied with the recommended 400 mg once-daily dose in a large proportion of patients, confirming the advantages of this simple dosing regimen.Trial registration: identifier: NCT00846911.
    Full-text · Article · Jan 2013 · BMC Pulmonary Medicine
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    • "In the 12-month period prior to study start, 46.9% (n = 5336/11,377) of patients had one or two episodes of AECB, whereas three or more episodes were reported in 38.1% (n = 4335/11,377) of patients. Comparing these data to a similar analysis of European data of the GIANT study, more European patients suffered from chronic bronchitis for more than 10 years, the proportion of female patients and patients ≥65 years was higher, and fewer patients were nonsmokers.10 "
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    ABSTRACT: A single infective acute exacerbation of chronic bronchitis (AECB) has a sustained effect on health status. Although a number of clinical investigations have demonstrated the efficacy of antibiotics in AECB, increased bacterial resistance has caused concern about the efficacy of currently available antibiotic therapies. This subanalysis of a global noninterventional study aimed to evaluate the impact of AECB on the patient and the community and the effectiveness and safety of a treatment with moxifloxacin (MXF) tablets in daily life clinical practice in China. This prospective, noninterventional, noncontrolled, multicenter observational study, which started in China in April 2004 and ended in February 2007, was part of the global GIANT study. Patients with a diagnosis of mild to severe AECB were treated with MXF tablets 400 mg for a period at the physician's discretion. The observation period for each patient covered a complete treatment period with MXF. For each patient, the physician documented data at an initial visit (baseline) and at least one follow-up visit. Data were collected on demography, diagnosis of infection, pretreatment, concomitant diseases and medications, MXF therapy, course of symptoms during investigations, and final assessment of therapy with respect to MXF. In the Chinese subset of the GIANT study, a total of 11,377 patients were included in the intention-to-treat/safety population. At the end of the initial treatment period, improvement and recovery from infection was observed for 98.6% (n = 11,217/11,377) and 92.6% (n = 10,540/11,377) of all patients. After 1 week of treatment, 76.3% (n = 8681/11,377) of patients had recovered. Median time until improvement and recovery was 3.0 and 6.0 days, respectively. Correspondingly, in 95.8% (n = 10,903/11,377) of all patients, overall effectiveness during the initial treatment period with MXF was assessed as "very good" or "good". Compared with the last AECB, the number of days with impact on daily-life activities and the number of nights with sleep disturbances decreased from 3.0 to 2.0 (median) and from 2.0 to 1.0 (median), respectively. In general, MXF treatment was very well tolerated, with physician's overall assessment of tolerability as "good" or "very good" in 95.2% (n = 10,834/11,377) of patients. The incidence rate of adverse events and adverse drug reactions was 0.82% (n = 93) and 0.67% (n = 76), respectively. The most frequent adverse events were gastrointestinal disorders such as nausea (0.31%, n = 35) and vomiting (0.19%, n = 22), which were mostly drug-related. One individual serious adverse event (dyspnea) occurred during the observation period, which was assessed as drug-related. MXF was effective and well tolerated in patients suffering from AECB. The fast speed of the drug's onset of action was associated with rapid improvement of clinical parameters.
    Preview · Article · Aug 2010 · Clinical Epidemiology
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    ABSTRACT: The present study was designed to describe the clinical profile of acute exacerbations of chronic obstructive pulmonary disease (COPD) and the treatment prescribed by primary care physicians (PCPs) in Spain. An observational, multicenter and cross-sectional study was performed in patients diagnosed with acute exacerbation of COPD and treated by PCPs. Patients diagnosed with asthma, cystic fibrosis, significant bronchiectasis or pneumonia were not included in the study. A total of 329 general physicians recruited 1088 evaluable patients across the country. Mean age was 66.5+/-10.2 years; male : female ratio was 3 : 1. Spirometry was performed in 28.3% of the patients. The number of acute exacerbations in the last year was 3.3+/-2.5; 88.7% had increased expectoration, 87.5% increased dyspnea, 64.4% increased sputum purulence, and 43.5% fever. A total of 6.1% (n = 59) of patients were hospitalized due to exacerbation. The most frequently prescribed medications were antibiotics (84.5%, n = 919), mucolytic agents (72.5%, n = 789), inhaled corticosteroids (ICs) (71.3%, n = 776), and short-acting beta-adrenergic drugs (67.8%, n = 738). Oral corticosteroids were prescribed to 436 patients (40.1%). The clinical profile of acute exacerbations of COPD treated in a primary care setting in Spain was characterized by shortness of breath and increased sputum production. Patients were managed by PCP mainly in outpatient clinics with antibiotics, mucolytic agents, inhaled corticosteroids, oral corticosteroids and short-acting beta-adrenergic agents. The percentage of patients with confirmed diagnosis of COPD by pulmonary function tests was very low.
    No preview · Article · Aug 2010 · Therapeutic Advances in Respiratory Disease
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