Hypoglycaemic episodes in patients with type 2 diabetes--risk factors and associations with patient-reported outcomes: The PANORAMA Study.

AIM: To explore the frequency of hypoglycaemic episodes, their risk factors, and associations with patient-reported outcomes in patients with type 2 diabetes enrolled in the PANORAMA cross-sectional study. METHODS: Five thousand seven hundred and eighty-three patients aged ≥ 40 years with type 2 diabetes duration ≥ 1 year were recruited in nine European countries. Patients reported severe and non-severe hypoglycaemic episodes during the past year at a single study visit. Patient-reported outcomes were measured by the Audit of Diabetes-Dependent Quality of Life, Diabetes Treatment Satisfaction Questionnaires, Hypoglycaemia Fear Survey-II, and EQ-5D Visual Analog Scale. RESULTS: During the previous year, 4.4% of the patients experienced ≥ 1 severe hypoglycaemic episode; among those without severe hypoglycaemia, 15.7% experienced ≥ 1 non-severe episode. Patients experiencing any hypoglycaemic episode reported a greater negative impact of diabetes on quality of life, greater fear of hypoglycaemia, less treatment satisfaction and worse health status than those with no episodes. In multivariate analyses hypoglycaemia was significantly associated with longer diabetes duration; presence of microvascular and, to a lesser extent, macrovascular complications; treatment with insulin, glinides or sulfonylureas; and use of self-monitoring blood glucose. CONCLUSION: In patients with type 2 diabetes, severe hypoglycaemic episodes were not uncommon and one in five experienced some form of hypoglycaemia during the previous year. Hypoglycaemia was associated with more negative patient-reported outcomes. The risk of hypoglycaemia increased with diabetes duration, presence of diabetes-related complications, use of self-monitoring blood glucose, insulin secretagogues, and insulin treatment.

Antibiotic treatment and factors influencing short and long term outcomes of acute exacerbations of chronic bronchitis.

BACKGROUND: The MOSAIC study compared moxifloxacin with three standard antibiotic regimens in patients with Anthonisen type 1 acute exacerbations of chronic bronchitis (AECB). Further exploratory analyses were performed to identify prognostic factors of short and long term clinical outcomes and their value for clinical research. METHODS: Outpatients aged > or =45 years were screened between AECB episodes, randomised to treatment upon presenting with an AECB, assessed 7-10 days after study treatment, and followed monthly until a new AECB or for up to 9 months. Logistic regression assessed the predictive factors for clinical cure (return to pre-AECB status) and clinical success (cure or improvement), and a stepwise Cox regression model time to a composite event (failure of study treatment, new AECB, or further antibiotic treatment for AECB). RESULTS: In multivariate analyses, clinical cure was positively influenced by treatment with moxifloxacin (odds ratio (OR) 1.49; 95% CI 1.08 to 2.04) while cardiopulmonary disease (OR 0.59; 95% CI 0.38 to 0.90), forced expiratory volume in 1 second (FEV1) <50% predicted (OR 0.48; 95% CI 0.35 to 0.67), and > or =4 AECBs in the previous year (OR 0.68; 95% CI 0.48 to 0.97) predicted a poorer outcome. For clinical success, treatment with moxifloxacin had a positive influence (OR 1.57; 95% CI 1.03 to 2.41) while cardiopulmonary disease (OR 0.41; 95% CI 0.25 to 0.68) and use of acute bronchodilators (OR 0.50; 95% CI 0.30 to 0.84) predicted a poorer outcome. The occurrence of the composite event was influenced by antibiotic treatment (hazard ratio (HR) 0.82; 95% CI 0.68 to 0.98), age > or =65 years (HR 1.22; 95% CI 1.01 to 1.47), FEV1<50% predicted (HR 1.27; 95% CI 1.05 to 1.53), > or =4 AECBs in previous year (HR 1.63; 95% CI 1.34 to 1.99), and acute bronchodilator use (HR 1.48; 95% CI 1.17 to 1.87). For the composite event the beneficial effect of moxifloxacin was primarily seen in patients aged > or =65 years. CONCLUSION: Despite selection of a homogeneous population of patients with chronic bronchitis, between group differences relating to antibiotic treatment could still be confounded by factors related to medical history, severity of disease, and use of concomitant medications. The design of future clinical trials should take these factors into account.

[Acute exacerbation of chronic bronchitis: patients, antibiotherapy, and guidelines]. / Exacerbation de bronchite chronique: enquête de pratique chez 101 médecins généralistes représentatifs.

OBJECTIVE: The aim of this study was to compare antibiotic prescriptions made by general practitioners to French recommendations for the management of Acute Exacerbation of Chronic Bronchitis (AECB) referring to the patient's socio-demographic data, history of Chronic Bronchitis (CB), current episode management, and quality of life. METHODS: This cross-sectional study was made on 101 general practitioners. RESULTS: Four hundred eighteen patients were included: mean age: 66 +/- 12 years; male patients 71%; mean history of CB: 13 years; cardiac comorbidity: 45%; depression: 34%; obstructive ventilatory syndrome: 64%; respiratory functional test performed: 44%; FEV1 <35%: 10%. An antibiotic was prescribed in 95% of cases. 94% of treated patients were classified as type 1 or 2, according to Anthonisen's criteria: 85% of these presented with purulent expectoration. The classification used in French recommendations was applied in 364/418 patients, 79 had simple CB, 231 had moderate obstructive CB, 43 had severe obstructive CB. The antibiotic (AB) prescriptions concerned mostly group 2. Group 2 AB were over-prescribed in 70% of patients suffering from obstructive CB or simple CB. But group 2 AB were under-prescribed in 25% of patients suffering from severe obstructive CB. CONCLUSION: Group 1 AB prescriptions were compliant with Anthonisen's criteria in most cases but the choice of AB did not follow French recommendations, with an over-prescription of group 2 AB and a bad assessment of simple CB.

Effectiveness of oral moxifloxacin in standard first-line therapy in community-acquired pneumonia.

Based on recent guidelines for the management of community-acquired pneumonia, this study was designed to evaluate the effectiveness of a new fluoroquinolone compared with standard antimicrobial regimens, in conditions relating as closely as possible to the real world setting. In this study, 564 patients were randomised to either oral moxifloxacin (400 mg o.d.) or to standard oral therapy (amoxicillin 1 g t.i.d. or clarithromycin 500 mg b.i.d. alone or in combination) for up to 14 days using a double-blind procedure. The choice between the three standard regimens was made by the clinician prior to randomisation. Clinical response, quality of life, symptoms, healthcare resources and safety were assessed. In the per-protocol population, clinical success was reported for 201 of 215 (93.5%) and 217 of 231 (93.9%) in the moxifloxacin and standard groups, respectively, at 7-10 days post-therapy. At 28-35 days follow-up, continued clinical cure was observed in 183 of 192 (95.3%) moxifloxacin and 207 of 221 (93.7%) standard groups. Drug-related adverse events were reported in 55 of 274 (20%) moxifloxacin and 86 of 279 (31%) standard patients with diarrhoea >5%. Oral moxifloxacin monotherapy was as effective as, and better tolerated than, optimal antibiotic strategy represented either by mono- or combination therapy (amoxicillin and/or clarithromycin) in community-acquired pneumonia management.

Quality of life in acute exacerbation of chronic bronchitis: results from a German population study.

This study reports on data from a study conducted in the Federal Republic of Germany examining the quality of life (QoL) of patients with chronic bronchitis (CB) and its acute exacerbations (AECB). Data from 320 patients were collected at AECB and subsequently during a stable phase (non-AECB) utilizing the St George's Respiratory Questionnaire (SGRQ) and the Nottingham Health Profile (NHP). As expected, the QoL of CB patients was poor, even at non-AECB, with patients reporting lower scores than patients with other chronic conditions. Patients reported significantly poorer QoL at AECB than at non-AECB. After adjusting for the severity of the underlying condition, poorer QoL at AECB was significantly and independently associated with older age, unemployment, increasing BMI, increasing number of prior AECBs, and Anthonisen AECB grade. While younger subjects reported significantly greater deterioration in QoL at AECB, the factors most consistently and independently associated with relative QoL deterioration at AECB were the number of prior AECBs and exposure to air pollution at home. In conclusion, this study highlights the detrimental effect of CB, and in particular AECB, on QoL. The association between QoL and patient reports of previous AECB number and air pollution are consistent with reports from other studies.

[Management of dyslipidemias diagnosed in general practice in France--The PRAGMA Study]. / Prise en charge des dyslipidémies diagnostiquées en médecine générale en France--etude PRAGMA.

Several studies have reported the penetration and impact of national and international recommendations on the management of dyslipidaemia, a major cardiovascular risk factor. Most of them were carried out on patients participating in clinical trials or on in-hospital cases. The PRAGMA study was developed in order to evaluate management of this condition in general practice, at the heart of the health care system. From September to December 1998, 1,717 general practitioners were chosen randomly and included 6,623 patients considered to have a lipid disorder. In this sample, the prevalence of the main risk factors was as follows: hypertension: 39.6%, diabetes: 11.6%, obesity: 19.6%, past or present smokers: 33.8%. The main lines of management consisted in prescribing lipid lowering drugs (96.6%) with dietary recommendations (95.8%) and a fall lipid profile (59.9%). The main factors spontaneously cited by the general practitioners as being decisional were: the total cholesterol level (47.8%), diet (40.8%), body weight (29.4%) and drug therapy (19.2%). The cardiovascular risk factors were rarely taken into account in their totality. These results suggest that the management of dyslipidaemia patients by general practitioners is far from being optimal. Efforts should be made to change attitudes to take into consideration the global cardiovascular risk factors of patients with lipid disorders.

[Characteristics and predictive value of quality of life in a French cohort of angina patients]. / Caractéristiques et valeur prédictive de la qualité de vie d'une cohorte française de patients angineux.

The study of quality of life (QoL) in a French cohort of patients suffering from angina pectoris was one of the objectives of the ELAN longitudinal study. It concerned 3,954 subjects (76% males) mean age: 67 +/- 11 years, followed up by 613 cardiologists which were invited to complete a series of baseline sociodemographic and clinical data and to answer a series of questions upon one year outcome (3,261 medical records available). QoL was assessed at baseline via a self-administered 12-item general questionnaire, the Short-Form 12 (SF-12), enabling to compute a mental component summary (CS-12) and a physical component summary (PCS-12) score. Mean MCS-12 in the ELAN cohort (49 +/- 7.5) was very close to the standards derived from general American population (50 +/- 10) or to the data available in a general French population (51.2 +/- 7.4). Whereas mean PCS-12 was hardly lower (about one standard deviation) in comparison with general American population (50 +/- 10) or with a general French population (48.4 +/- 9.4). QoL was higher in males and linked to age in a contrasted way (higher MCS-12 and lower PCS-12 in elderly; p < 0.0001). It depended on the clinical condition (lower MCS-12 associated with mixed-type angina pectoris or with more severe angina and with persistent smoking; lower PCS-12 associated with mixed type or more severe angina, with cardiac failure episodes, arteritis obliterans, stroke antecedents or left ventricular hypertrophy). Both scores were negatively correlated, in multivariate regression analysis, with the severity of persisting angina at one year, after controlling for the severity of baseline angina and the other confounding variables. Above all, MCS-12 and especially PCS-12, predicted major coronary events at one year (death, myocardial infarction, angioplasty, coronary by-pass surgery). In a multivariate logistic regression analysis, low baseline PCS-12 was associated with higher risk for cardiovascular death at one year (OR = 2.44; 95% CI = 1.25-4.74; p < 0.01). These results confirm the clinical validity of SF-12 (cross sectional stage of the study) and stress its prognostic value independent from the other risk factors (longitudinal stage of the study).

[Characteristics of a cohort of 4,000 French patients with angina. The ELAN study]. / Caractéristiques d'une cohorte française de 4,000 patients angineux. L'étude ELAN.

The ELAN (Etude Longitudinale dans l'ANgor) study was carried out to evaluate factors influencing the occurrence of death, myocardial infarction and revascularization procedures in patients with known angina pectoris. Analysis of baseline data collected in January 1997 involves 4,035 patients throughout France, which were recruited by 613 cardiologists practising on a private, hospital or mixed basis. The study population comprised 75% of men with a mean age of 65 years and 25% of women with a mean age of 70 years. Eighty eight percent of the patients had at least one cardiovascular risk factor, and nearly half of them had two or more factors; hypercholesterolemia and hypertension were the two most frequent ones. Reported cardiovascular past events included myocardial infarction in 47% of patients, PTCA in 33% and aorto-coronary bypass in 24%. Angina pectoris had been diagnosed within the previous year in 39% of patients. Exertional angina was the most common type (66%), with grade I/II angina being most frequently found (more than 70% of all cases). Management strategies are especially described for angina patients diagnosed within the previous year. More than half of the patients had undergone exercise testing within the previous 12 months, while scanning and coronary arteriography had been performed in 15% and 72%, respectively. Ninety five percent of patients were under antianginal drug therapy, with combined therapies being used in 58% of them. The most frequently prescribed drugs were betablockers (63%) and nitrates (53%). In 74% of patients, aspirin was given in addition to conventional antianginal agents. These data will be reviewed in a one-year cohort analysis as potential predictive factors for the occurrence of cardiovascular events.

[One-year follow-up of a population of patients with angina. Factors influencing mortality and occurrence of cardiovascular events. Results of the ELAN study]. / Le devenir à un an d'une population de patients angineux. Facteurs influençant la mortalité et la survenue des événements cardiovasculaires. Les résultats de l'étude ELAN.

The ELAN (Etude longitudinale dans l'angor) study was carried out both to acquire better knowledge of the occurrence of major cardiovascular events (myocardial infarction, revascularization surgery, death) in patients followed up for angina pectoris, and to determine the factors influencing such events. A cohort of angina patients was formed in January 1997, and 3,284 patients were followed up by 488 French cardiologists during a one-year period. Of these 3,284 patients, 96 (29/1000) died; causes of death included underlying coronary heart disease in 31, sudden death in 8, other cardiac aetiologies in 35, and noncardiac causes in 22. Sixty-nine (21/1000) patients developed myocardial infarction, 240 (73/1000) underwent PTCA, and 119 (36/1000) underwent coronary bypass surgery. Factors associated with an increased risk of death were age, diabetes mellitus, heart failure and angina type, mixed and rest angina being associated with poorer prognosis compared to exertional angina. Infarction risk increased with age and a history of previous infarction. Analysis of therapeutic factors after adjustment for the above risk factors showed a beneficial effect of betablockers on both cardiovascular and all-cause mortality and of aspirin on all-cause mortality.