[French data from the Continuing to Confront COPD (C2C) survey]. / Données françaises dans l'enquête internationale Continuing to confront COPD (C2C).

INTRODUCTION: This article describes the French data which contributed to the international "Continuing to Confront COPD" (C2C) survey conducted in 2013 across 12 countries. Its objective was to describe the characteristics, symptoms and impact of COPD on health status, daily activities and working life in adults identified with the study definition as COPD; i.e., reporting a diagnosis of COPD, emphysema, chronic bronchitis (CB) or symptoms of CB either currently present or for which they had been treated in the past. METHODS: Subjects 40 years or older were screened using random-digit-dialing and those fulfilling the study COPD definition were invited to complete the full survey. RESULTS: The proportion of respondents with COPD (according to study definition) in France was estimated at 7.5%. Among 300 respondents with COPD and complete questionnaire data, 48% were male, 44% aged over 70years, 45% were overweight and 72% had a smoking history. COPD had a severe or very severe impact (COPD assessment test score>20) on health for 43%. Dyspnea (mMRC ≥ 1) was reported by 70% and a limitation of at least 20% of daily activities by 65%. The mean number of exacerbations was 2/year and 16% had been admitted to hospital for respiratory problems during the past year. However, using direct questions, 80% subjects considered that they had mild to moderately severe disease and 78% reported an acceptable health status. CONCLUSION: The impact of COPD is markedly underestimated by respondents with COPD despite a high level of symptoms, poor health status and frequent exacerbations as assessed with validated measures.

Prevalence and burden of dyspnoea among COPD patients in Japan.

BACKGROUND AND AIMS: Dyspnoea is the most common symptom of chronic obstructive pulmonary disease (COPD) significantly affecting activity, impairing patients' well-being and contributing to the economic burden of COPD. The objective of this study was to estimate the prevalence of dyspnoea and its impact on COPD management costs in Japan. METHODS: A cross-sectional survey was conducted among 82 internal medicine physicians and 85 respiratory specialists representing 420 patients with COPD in Japan. Information was collected on demographic and clinical characteristics, dyspnoea (mMRC scale), and healthcare resource use. Dyspnoea prevalence was estimated among all patients and those on specific COPD treatments. The economic burden was derived from two cohorts based on their level of dyspnoea that were matched by propensity scores balancing their demographic and disease burden characteristics. RESULTS: Moderate-severe dyspnoea (mMRC score ≥ 2) was reported by 37.5% of COPD patients and ranging from 21.5% among patients treated with a mono bronchodilator to 59.8% among patients treated with triple therapy. Descriptive analysis showed that dyspnoeic patients have higher annual costs attributable to consultations (€2999 vs. €1906), medications (€1139 vs. €716), exacerbations (€674 vs. €36), other resources (€1789 vs. €140) and in total (€6348 vs. €2797) (p < 0.0001 for all comparisons) compared to patients with mild or no dyspnoea (mMRC score < 2). The total costs remained significantly higher in a propensity-matched cohort adjusted for severity and cardiovascular comorbidity [€6776.1 vs. €4461.3, p = 0.0236]. CONCLUSION: Moderate-severe dyspnoea is common among consulting COPD patients in Japan and is a significant cost driver for the healthcare system.

One-year change in health status and subsequent outcomes in COPD.

BACKGROUND: Poor health status has been associated with morbidity and mortality in patients with COPD. To date, the impact of changes in health status on these outcomes remains unknown. AIMS: To explore the relationship of clinically relevant changes in health status with exacerbation, hospitalisation or death in patients with COPD. METHODS: Characteristics and health status (St George's Respiratory Questionnaire, SGRQ) were assessed over a period of 3 years in 2138 patients with COPD enrolled in the Evaluation of COPD Longitudinally to Identify Predictive Surrogate Endpoints (ECLIPSE) study: a longitudinal, prospective, observational study. Associations between change in health status (=4 units in SGRQ score) during year 1 and time to first exacerbation, hospitalisation and death during 2-year follow-up were assessed using Kaplan-Meier plots and log-rank test. RESULTS: 1832 (85.7%) patients (age 63.4±7.0 years, 65.4% male, FEV1 48.7±15.6% predicted) underwent assessment at baseline and 1 year. Compared with those who deteriorated, patients with improved or stable health status in year 1 have a lower likelihood of exacerbation (HR 0.78 (95% CI 0.67 to 0.89), p<0.001 and 0.84 (0.73 to 0.97), p=0.016, respectively), hospitalisation (0.72 (0.58 to 0.90), p=0.004 and 0.77 (0.62 to 0.96), p=0.023, respectively) or dying (0.61 (0.39 to 0.95), p=0.027 and 0.58 (0.37 to 0.92), p=0.019, respectively) during 2-year follow-up. This effect persisted after stratification for age and the number of exacerbations and hospitalisations during the first year of the study. CONCLUSIONS: Patients with stable or improved health status during year 1 of ECLIPSE had a lower likelihood of exacerbation, hospitalisation or dying during 2-year follow-up. Interventions that stabilise and improve health status may also improve outcomes in patients with COPD. TRIAL REGISTRATION NUMBER: NCT00292552, registered at ClinicalTrials.gov.

[Changes in weight and diabetes compensation (HbA1c) in patients with diabetes mellitus type 2 after adding exenatide (Byetta) to the current treatment in 28 diabetology departments in the Czech Republic -  BIBYII study (observations lasting 24 months)]. / Zmeny hmotnosti a kompenzace diabetu (HbA1c) u nemocných s diabetes mellitus 2. typu po pridání exenatidu (Byetta) ke stávající lécbe ve 28 diabetologických ambulancích v CR -  studie BIBYII (sledování 24 mesícu).

UNLABELLED: BIBYII STUDY OBJECTIVE: To obtain experience with longterm (24 months) exenatide treatment (Byetta) in patients with diabetes mellitus type 2 from a common clinical practice of diabetology departments in the Czech Republic. TYPE OF OBSERVATION: Observational study conducted by a randomly selected group of outpatient medical practitioners from 28 diabetology departments in the Czech Republic. OBSERVED AND ASSESSED POPULATION: From the original population of 465 patients, who underwent a minimum of three months Byetta treatment, 169 patients (36.6%) remained during the second prolonged observation after 18 months, and 76 patients completed 24 months of uninterrupted Byetta treatment. The following basic information about the patients was collected: year of birth, sex, age when diabetes mellitus (DM) manifested, height, maximum weight before diabetes and when DM manifested. The study recorded the following values in three- month intervals: weight, waistline, glycated haemoglobin (HbA1c), and DM treatment. The population of the prolonged observation comprised 50.3% women and 49.7 % men, and the average age at the time of DM2 manifestation was 48.0 (20- 73 years). RESULTS: At the beginning of Byetta treatment, the average maximum BMI in the subpopulation observed for 24 months was 38.44; after 3, 6, 9, 12 and 24 months the following levels were measured, respectively: 36.79, 36.22, 35.91, 35.57 and 35.58. The original HbA1c level of 7.44% at the beginning of Byetta treatment decreased after 3, 6, 9, 12 and 24 months to 6.33, 5.98, 5.83, 5.86 and 5.93%. CONCLUSION: Adding Byetta to the currently applied treatment of obese patients with diabetes mellitus type 2 over a period of 24 months has led to an improvement in HbA1c level by 1.51%, and BMI level was reduced by 2.37 after two years of Byetta treatment.

[Changes in weight and diabetes compensation (HbA(1c)) in patients with diabetes mellitus type 2 after adding exenatide (Byetta) to the current treatment in 28 diabetology departments in the Czech Republic - BIBY-I study (observations lasting 3 to 12 months)]. / Zmeny hmotnosti a kompenzace diabetu (HbA(1c)) u nemocných s diabetes mellitus 2. tpu po pridání exenatidu (Byetta) ke stávající lécbe ve 28 diabetologických ambulancích v CR--studie BIBY-I (sledováni 3-12 mesícu).

UNLABELLED: BIBY STUDY OBJECTIVE: To obtain experience with exenatide treatment (Byetta) in patients with diabetes mellitus type 2 in a common clinical practice ofdiabetology departments. TYPE OF OBSERVATION: Observational study conducted by a randomly selected group of outpatient medical practitioners from 28 diabetology departments in the Czech Republic. OBSERVED AND ASSESSED POPULATION: 465 patients underwent at least three months of Byetta treatment; 347 persons (74.6% ofthe research population) stayed forthe extended observation of 6-12 months. Apart from the basic identification data (year of birth, sex, age when diabetes mellitus manifested, height, maximum patient weight before diabetes and when diabetes mellitus manifested), the following information was recorded in three-month intervals: weight, waistline, glycated haemoglobin (HbA(1c)), and diabetes mellitus treatment The population included 50.3% women and 49.7% men, and the average age at the time of diabetes manifestation was 48 (20-73 years). The period between the diabetes manifestation and the start of exenatide treatment was 8.3 years on average. RESULTS: The average maximum BMI value before the detection of diabetes was 39.05 (+/- 6.73); at the time of the diabetes manifestation 37.88 (+/- 6.40); and at the start of Byetta treatment 39.01 (+/- 6.22). The BMI after three, six, and 12 months of treatment was as follows: 37.86 (+/- 6.12), 37.18 (+/- 6.0), and 36.60 (+/- 6.21); it decreased by > or = 0.5 in 83.3% patients who were under observation for 12 months. HbA(1c) value decreased in the first three months from 7.39% (+/- 1.57) to 6.41% (+/- 1.34), p < 0.0001. In the period of three-six months, the value decreased to 6.22% (+/- 1.34), and after 12 months, HbA(1c) was at 6.04 (+/- 1.20). An improvement in HbA(1c) value of 0.5-2.0% occurred after the first year in 49% of our research population. The waistline was measured on a regular basis in only 267 patients (58.9%). The average initial value of 120.7 cm was reduced within three months of the treatment to 118.3 cm, and within six and 12 months to 117.3 and 112.6 cm respectively. CONCLUSION: Adding Byetta to the currently applied treatment of obese patients with diabetes mellitus type 2 led, in 66.8% of the population, to a statistically significant reduction in HbA(1c) levels in the first three-six months of the treatment; after 12 months of treatment, 25% of the population was still showing an improvement in HbA(1c) of > 2.0%. Of observed patients, 74.4% significantly reduced their BMI (by > 0.5) during the first three months; 39.6% of patients reduced their BMI in the period of three-six months.

Inflammatory changes, recovery and recurrence at COPD exacerbation.

Chronic obstructive pulmonary disease (COPD) exacerbations are associated with increased airway and systemic inflammation, though relationships between exacerbation recovery, recurrent exacerbation and inflammation have not been previously reported. In the present study, inflammatory changes at COPD exacerbations were related to clinical nonrecovery and recurrent exacerbations within 50 days. Serum interleukin (IL)-6, C-reactive protein (CRP), sputum IL-6 and IL-8 were measured in 73 COPD patients when stable, at exacerbation and at 7, 14 and 35 days post-exacerbation. In 23% of patients, symptoms did not recover to baseline by day 35. These patients had persistently higher levels of serum CRP during the recovery period. A total of 22% of the patients who had recurrent exacerbations within 50 days had significantly higher levels of serum CRP at day 14, compared with those without recurrences: 8.8 mg.L(-1) versus 3.4 mg.L(-1). Frequent exacerbators had a smaller reduction in systemic inflammation between exacerbation onset and day 35 compared with infrequent exacerbators. Nonrecovery of symptoms at chronic obstructive pulmonary disease exacerbation is associated with persistently heightened systemic inflammation. The time course of systemic inflammation following exacerbation is different between frequent and infrequent exacerbators. A high serum C-reactive protein concentration 14 days after an index exacerbation may be used as a predictor of recurrent exacerbations within 50 days.

C-reactive protein in patients with COPD, control smokers and non-smokers.

BACKGROUND: Patients with chronic obstructive pulmonary disease (COPD) have raised serum levels of C reactive protein (CRP). This may be related directly to COPD and its associated systemic inflammation or secondary to other factors such as concomitant ischaemic heart disease (IHD) or smoking status. The aim of this study was to evaluate IHD and smoking as potential causes of raised CRP levels in COPD and to test the association between inhaled corticosteroid (ICS) use and serum CRP levels. METHODS: Cross sectional analyses comparing cohorts of 88 patients with COPD, 33 smokers (S), and 38 non-smoker (NS) controls were performed. Clinical assessments included a complete medical history, pulmonary function, 6 minute walk test (6MWT), cardiopulmonary exercise test, and high sensitivity serum CRP measurements. RESULTS: Serum CRP levels were significantly higher in patients with COPD (5.03 (1.51) mg/l) than in controls (adjusted odds ratio 9.51; 95% confidence interval 2.97 to 30.45) but were similar in the two control groups (S: 2.02 (1.04) mg/l; NS: 2.24 (1.04) mg/l). There was no clinical or exercise evidence of unstable IHD in any of the subjects. CRP levels were lower in COPD patients treated with ICS than in those not treated (3.7 (3.0) mg/l v 6.3 (3.6) mg/l); this association was confirmed in an adjusted regression model (p<0.05). CONCLUSION: CRP levels are raised in COPD patients without clinically relevant IHD and independent of cigarette smoking, and reduced in patients with COPD using ICS. CRP may be a systemic marker of the inflammatory process that occurs in patients with COPD.

[Characteristics of patients with osteopenia treated with glucocorticoids at the Osteoporosis Clinic of the Medical Faculty Hospital in Hradec Kralove]. / Charakteristika nemocných s osteopenií lécených glukokortikoidy dispenzarizovaných v poradne pro osteoporózu FN Hradec Králové.

One-hundred-ninety-seven osteopenic or osteoporotic patients registered at the University hospital osteology outpatient clinic during 1995-1999 and exposed to glucocorticoids were included in the cohort. Prevalence of glucocorticoid treatment (of all patients) was 12.4%. The patients diagnosed with rheumatoid arthritis showed the greatest reduction in bone density (average T-score = -2.70), fractures were most frequently recorded in patients suffering from asthma or lupus erythematodes.

[Monitoring utilization of hypolipemic agents using an insurance company database]. / Sledování spotreby hypolipidemik pomocí databáze pojistovny.

Databases of health insurance companies can provide information on the motion of a drug in the society. The present paper examines several databases of health insurance companies and analyzes the development of the consumption of hypolipidemic agents in 1994 through 1998. So-called evaluation databases making it impossible to identify a particular patient and the prescribing physician were prepared for the evaluation. They were obtained from the VZP central health insurance office, VZP district health insurance offices in Hradec Králové and Kladno, and the Zamestnanecká pojistovna Skoda (Employees Health Insurance Company Skoda). It was not necessary to blind the data in the first cohort, in the second one it was carried out by shortening the identification numbers, and in others by introducing artificial identification codes. The consumption was expressed in DDD and in the relative representation in the group. The consumption of the principal groups of hypolipidemic agents (fibrates, statins, sequestrants of bile acids, and derivatives of nicotinic acid) and the individual medicinal substances was evaluated. Relative values of consumption were obtained by calculation to the magnitude of the denominator--the number of the insured, or the number of patients to whom a hypolipidemic agent was prescribed. The consumption was on the increase in all three databases, in four years increasing from approx. 0.4-4DDD/1000 of the insured/day to 16-24DDD/1000 of the insured/day. At the beginning, the main share in the consumption of hypolipidemic agents was represented by fibrates, approx. 90%, but in four years this share decreased to only 60%, whereas in the period under study the share of statins increased up to 30%. Databases of health insurance companies do not significantly differ in the consumption of hypolipidemic agents, which may give evidence of their validity. In the course of the study, an increase in the consumption of hypolipidemic agents, primarily statins, was found. The shift in the consumption of statins corresponds with the available information about the evidence of their therapeutic effectiveness. The average consumption per one patient does not reach 1DDD, which is a signal that probably very few patients receive long-term treatment and that new patients emerge during the year.

[Analysis of the activities of the Information Service of the National Institute for Drug Control]. / Analýza aktivit informacní sluzby Státního ústavu pro kontrolu léciv (SUKL).

An analysis was carried out concerning the questions regarding drug information solved by the information service section of the State Institute for Drug Control (SUKL) in 1992-1995. A rapid decrease in the number of questions was observed during the period under study. This trend was mainly caused by a decline in questions regarding the availability of drugs in the market. Questions were posed in a similar ratio by physicians and pharmacists predominantly from Prague and surrounding areas. Questions from other categories of health-care professionals and the lay public are in minority. Most questions focus on the characteristic of the drug and its availability. AISLP, Martindale and Rote Liste serve as the principal information sources.

European drug information centres--survey of activities.

A questionnaire survey of European drug information centres (DICs) was conducted. DICs mentioned in the ESCP directories and other sources were identified and contacted. Information on basic characteristics was obtained: affiliation, the scope of activities, employees, question-answer service characteristics, information sources and the economic aspects of the DICs' work. Information from 84 DICs was analysed (return rate = 71.3%). DICs are mainly affiliated to hospitals (68%), rather rarely with faculties of pharmacy (6%) or with faculties of medicine (8.3%). Activities of DICs mainly include: question-answer service (98%), issue of bulletins (68%), participation in P&T committees (63%), tuition (61%) and drug-use evaluation (52%). Pharmacists, 1-2 full- or part-time, are the most frequent employees working in the DICs. When the question-answer service was analysed, it was found that 56% of the DICs are open only to the health-care professionals and 43% provide a service to the lay public. Questions are mainly concerned with the side effects, indication/therapeutic use and the dosage of the drugs. The majority of DICs (91%) document their activities, very often on a computer database. Quality assurance is provided by almost 75% of DICs, usually by a review (58%) or a feed-back questionnaire (32%). Information sources listed as most frequently used include Martindale--The Extrapharmacopeia, journals such as Lancet, Medline and Micromedex databases. DICs are usually financially supported by the organizations to whom they are affiliated. Fees are charged, for special activities, by 9.5% of DICs.

Drug information centre--analysis of activities of a regional centre.

Description and evaluation of a drug information centre's (DIC) professional activities one year after establishment are summarized. The aims of the centre are: to evaluate which problem areas are frequently requested, how frequently and by whom; which information sources are the most appropriate for the service and the approximate cost of such a service. We received 80 questions during the first 8 months. The questions were mainly asked by hospital physicians (32.5%) and pharmacists (32.5%), other health-care professionals were a minority; the scopes of most frequently asked questions include general properties of active substances (12.2%), contents of particular preparations (21%), dosage (11%), side effects (21%) and indications/contraindications (15%). Cost of the service included variable (mainly phone and mail charges, copy and print of the documents) and fixed costs (cost of software and salary of the staff).

Typhoid fever survey in two localities in Vietnam.

As a part of multipurpose health survey of the population in Vietnam the antibodies against S. typhi were determined by the micromethod using haemagglutination test (O-antigen 9, 12) and agglutination test using standard H-diagnostic antigen (d). Totally 292 sera were examined, 139 from Duyen Thai village and 154 from Mai Chau. The data on vaccination against typhoid fever are recorded only in 102 persons. The positivity on Vi antibodies is very high--70% in Duyen Thai and 47% in Mai Chau. This finding is significant according to the high titres in the carriers of S. typhi. The titres of all antibodies are lower in Mai Chau area situated in mountains then in crowded lowlands of Duen Thai. The level of antibodies is decreasing with age. The frequency distribution of antibodies by age proves endemicity of the disease in area, where a large part of population is infected already before reaching 20 years of age. The effectivities of vaccination is discussed.