Characterisation of exacerbations of chronic bronchitis and COPD in Europe: the GIANT study

Article (PDF Available)inTherapeutic Advances in Respiratory Disease 3(6):267-77 · October 2009with69 Reads
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.
    • The first study enrolled outpatients aged ≥12 years under daily treatment with oral moxifloxacin for AECB. It aimed to determine the impact of AECB on the patient and the community and to evaluate the safety and efficacy of moxifloxacin in daily practice [92,93]. The second study evaluated patients aged ≥10 years with cSSTIs: moxifloxacin under daily-life treatment conditions appeared effective and the incidence of AEs was low [94].
    [Show abstract] [Hide abstract] ABSTRACT: New initiatives have been introduced in Europe and the USA to encourage more rapid development of antibiotics. The need to ensure these new antibiotics can be safely used in children, and especially neonates, is important owing to high antimicrobial resistance in these patient groups. This review aims to determine what lessons can be learnt from the recent regulatory processes to speed up access to new medicines for children, focusing on antibiotics licensed for adults by the EMA since 2000. For the 11 newly approved antibiotics, 31 clinical trials enrolling children in Europe were identified. However, many of these trials included both adults and children but did not provide a subset analysis for paediatrics, limiting the relevance of their findings. Some studies have been prematurely terminated and others are apparently active but are still not yet recruiting patients. Among paediatric-specific studies, 18 evaluate safety and efficacy of new compounds, 4 are pharmacokinetic studies, but only 2 focus on neonates. Nearly all studies with an agreed Paediatric Investigation Plan have just started or are not yet recruiting. For most antibiotics, despite adult phase 3 studies being completed, with specific concerns for particular drugs already noted, it will take another 3-5 years before adequate prescribing information becomes available for paediatricians. Evidence from this review suggests that we could do better. Lessons should be learnt from paediatric antiretroviral development, with neonatal and paediatric pharmacokinetic, clinical trial and pharmacovigilance drug development programmes being run directly in parallel with adult studies-not a decade behind.
    Full-text · Article · Jun 2013
    • As approximately 16% of patients who received moxifloxacin were classified with Anthonisen type III AECB, antibiotic therapy was not prescribed in accordance with current guidelines in all circumstances. A similar experience was reported in the GIANT study [29]. A strength of observational studies is that they provide an important accompaniment to randomized controlled trials and reflect real-world practice in terms of prescribing behavior [41] .
    [Show abstract] [Hide abstract] 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
    • 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
    [Show abstract] [Hide abstract] 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.
    Article · Aug 2010
  • [Show abstract] [Hide abstract] 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.
    Article · Aug 2010
  • [Show abstract] [Hide abstract] ABSTRACT: While it is known that asthma symptoms have a very variable pattern, the general belief is that the respiratory symptoms in COPD patients usually present little or no variability. Nevertheless, COPD patients report having "bad days". The objective of this present study was to evaluate the variability of the respiratory symptoms and their impact on the daily activities of a cohort of Spanish COPD patients. We present the results of the Spanish patients who participated in a cross-sectional epidemiological study carried out in 17 European countries. Pulmonologists and Family Care physicians recruited patients with stable severe COPD (FEV1<50%). The perception of the patients on the variation in their symptoms was recorded by telephone interviews. A total of 472 patients provided data that was valid for analysis. Mean age was 68.6; 93% were men; mean FEV1(%) was 41%. 84.1% of the patients experimented at least one respiratory symptom in the previous week and 60.9% affirmed that their symptoms varied over the course of the day or week. The moment of the day when the symptoms were perceived to be more intense was during the morning. An important proportion of severe COPD patients perceive variability in their respiratory symptoms, with a greater intensity in the morning. The observation can have implications in treating patients with severe COPD as variability can be an initial sign of decompensation of the disease.
    Full-text · Article · Sep 2011
  • [Show abstract] [Hide abstract] ABSTRACT: We examined the correlation between sputum colour and the presence of potentially pathogenic bacteria in acute exacerbations of chronic bronchitis (AECBs). Data were pooled from six multicentre studies comparing moxifloxacin with other antimicrobials in patients with an AECB. Sputum was collected before antimicrobial therapy, and bacteria were identified by culture and Gram staining. Association between sputum colour and bacteria was determined using logistic regression. Of 4,089 sputum samples, a colour was reported in 4,003; 1,898 (46.4%) were culture-positive. Green or yellow sputum samples were most likely to yield bacteria (58.9% and 45.5% of samples, respectively), compared with 18% of clear and 39% of rust-coloured samples positive for potentially pathogenic microorganisms. Factors predicting a positive culture were sputum colour (the strongest predictor), sputum purulence, increased dyspnoea, male sex and absence of fever. Green or yellow versus white sputum colour was associated with a sensitivity of 94.7% and a specificity of 15% for the presence of bacteria. Sputum colour, particularly green and yellow, was a stronger predictor of potentially pathogenic bacteria than sputum purulence and increased dyspnoea in AECB patients. However, it does not necessarily predict the need for antibiotic treatment in all patients with AECB.
    Article · Oct 2011
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