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For relapsed or refractory multiple myeloma (RRMM), a series of novel agents (thalidomide, bortezomib and lenalidomide) has emerged during the latest decade, but their use in routine clinical practice is not well documented as well as the cost of RRMM. Our aim is to review the therapeutic management of such patients in France and to estimate the associated costs. A retrospective cohort study, based on chart reviews, was conducted in French Haematology Departments over the period 2004-2007 and the associated direct costs estimated. One hundred and two patients with a relapse after first-line therapy were selected from five centres. The average follow-up from diagnosis or the date of first relapse to death or to the latest news was respectively 56·25 and 23·53 months. Novel agents were used in 73% of all cases, and in all cases of first relapse. Thalidomide and bortezomib were respectively the most frequently used second-line (57%) and third-line treatments (44%). The average number of lines of treatment received per patient as from first relapse was 2·75 (min 1; max 8) and the mean direct cost per month was estimated at 3130 € after the first relapse. This cost was represented in greater part by the cost of chemotherapy drugs (66%). The use of novel agents such as thalidomide, bortezomib and lenalidomide for RRMM is highly prevalent in France from the first relapse. The associated medical cost is substantial mainly due to the cost of the new agents. [ABSTRACT FROM AUTHOR]

Summary: The methodological approach of the economic evaluation of drugs in pediatrics is illustrated by the case study of the prophylaxis for RSV infections using palivizumab in the French setting. The indications for the reimbursement of this treatment have been restricted to premature children with bronchopulmonary dysplasia (BPD) or hemodynamically significant congenital-heart disease. A model was developed primarily using the results of the pivotal clinical studies on palivizumab. Unit costs were estimated (2006 values) in both societal and payer''s perspectives. An assumption was made and discussed on the benefits of the prophylaxis on mortality. Based on the different data available and the estimated costs and benefits, different cost-effectiveness ratios (CERs) were estimated from both the society''s and payer''s points of view. A discount rate of 3% was applied to benefit. The CER obtained in the most unfavorable case is considered acceptable for the innovative-medical technologies in the French-healthcare system. Some of the parameters used by the model will be illustrated from the EPIPAGE study data from 2 of the 9 regions involved in this study: this evaluation suggests that the children not having an RSV infection during their 1st year of life will continue to require significantly fewer hospitalizations in the following years. These additional evaluations also suggest that the model overestimates the costs of the treatment with regard to the true medical situation. This could be explained by the model not using the children''s exact weight or the real number of injections because the children had been discharged from the maternity ward based on their date of birth and the epidemic period. In spite of these factors, RSV prophylaxis using palivizumab in premature children with BPD or hemodynamically significant congenital-heart disease can be considered cost-effective in France. [Copyright &y& Elsevier]

In this paper we propose an iterative algorithm for the solution of Volterra equations of the first kind whose kernel is a square matrix. The algorithm, essential the Lavrientev method coupled with discretization, is "direct in the sense that preliminary numerical computation of the derivative of the observed variable is not required. We assume boundedness of the input μ and mild regularity conditions of the kernel. We prove convergence of the algorithm in L[supP] (0,T), 1 ≤ p < +∞ and uniform convergence on the intervals where the input is continuous. Under additional information on μ we give both integral and pointwise convergence estimates. The observed variable is read with errors, at discrete time instants. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To estimate the direct medical costs associated with obesity in France. DESIGN: Analysis of the French 1991-1992 National Household Survey database comprising a representative sample of 14,670 individuals aged 18 y and over. A subgroup of subjects with a body mass index (BMI) ≥30 kg/m² was compared with a control group of normal-weight individuals (BMI 18.5-25 kg/m²) matched on age, gender and education level. MEASUREMENTS: Self-reported weight and height used to calculate individual body mass index and health expenditures in a 3 month period, and morbidity as declared by respondents to the national household survey and verified on medical records. RESULTS: The direct cost attributable to obesity (BMI ≥ 30 kg/m²) was estimated to be in the range 4.2-8.7 billion French Francs (FF) in 1992 value, that is between 0.7 and 1.5% of total health expenditures. CONCLUSION: These results were of the same order of magnitude as similar estimates obtained by a top-down approach for the same year and setting. [ABSTRACT FROM AUTHOR]

We study the dynamics of expansive cellular automata. We prove that a cellular automaton is expansive if and only if it is topologically conjugate to an appropriate one-sided subshift. We define a large class of expansive cellular automata in terms of the permutivity of the local rule on which they are based. We prove that each cellular automaton of this class is topologically conjugate to a onesided full shift. Since one-sided full shifts are widely recognized as the paradigm of chaotic systems, we conclude that the above mentioned cellular automata are chaotic according to any reasonable definition of chaos. We provide a technique to construct expansive cellular automata which are topologically conjugate to onesided full shifts but do not belong to the above defined class. Finally, we investigate connections between expansivity, topological transitivity, and surjectivity. [ABSTRACT FROM AUTHOR]

This 9-month pragmatic study compared 2 therapeutic regimens in the management of osteoarthritis of the hip and knee. Patients received either diacerein 100 mg/day plus standard osteoarthritic therapy for 6 months, followed by a 3-month monitoring period without diacerein, or standard therapy alone for the entire 9-month period. A total of 207 patients with osteoarthritis of the knee and hip were enrolled. Improvements in Lequesne's functional index and quality-of-life scores (revised Arthritis Impact Measurement Scales Health Status Questionnaire and Nottingham Health Profile), and decreases in nonsteroidal anti-inflammatory drug and analgesic consumption were significantly greater with diacerein plus standard therapy than with standard therapy alone. The overall assessment of therapy by patients was good or excellent for 60% of those who received diacerein plus standard therapy, compared with 26% who received standard therapy alone. Medical and paramedical procedures carried out in addition to those stipulated in the protocol (medical consultations, physiotherapy, nursing, etc.), osteoarthritisrelated, were fewer and less costly in the diacerein plus standard therapy group than in the standard therapy group. The average outpatient cost (in 1995 French francs) of osteoarthritis treatment in the standard therapy group was FF2272 compared with FF2360 in the diacerein plus standard therapy group. The cost-effectiveness ratios per point scored on Lequesne's index were FF1893 for the standard therapy group and FF1072 for the diacerein plus standard therapy group, leading to a saving of 43% with diacerein plus standard therapy. The marginal cost (additional cost corresponding to the clinical benefit obtained by adding diacerein to standard treatment) was FF88 per point scored on Lequesne's index. [ABSTRACT FROM AUTHOR]

This 9-month pragmatic study compared 2 therapeutic regimens in the management of osteoarthritis of the hip and knee. Patients received either diacerein 100 mg/day plus standard osteoarthritic therapy for 6 months, followed by a 3-month monitoring period without diacerein, or standard therapy alone for the entire 9-month period. A total of 207 patients with osteoarthritis of the knee and hip were enrolled. Improvements in Lequesne's functional index and quality-of-life scores (revised Arthritis Impact Measurement Scales Health Status Questionnaire and Nottingham Health Profile), and decreases in nonsteroidal anti-inflammatory drug and analgesic consumption were significantly greater with diacerein plus standard therapy than with standard therapy alone. The overall assessment of therapy by patients was good or excellent for 60% of those who received diacerein plus standard therapy, compared with 26% who received standard therapy alone. Medical and paramedical procedures carried out in addition to those stipulated in the protocol (medical consultations, physiotherapy, nursing, etc.), osteoarthritisrelated, were fewer and less costly in the diacerein plus standard therapy group than in the standard therapy group. The average outpatient cost (in 1995 French francs) of osteoarthritis treatment in the standard therapy group was FF2272 compared with FF2360 in the diacerein plus standard therapy group. The cost-effectiveness ratios per point scored on Lequesne's index were FF1893 for the standard therapy group and FF1072 for the diacerein plus standard therapy group, leading to a saving of 43% with diacerein plus standard therapy. The marginal cost (additional cost corresponding to the clinical benefit obtained by adding diacerein to standard treatment) was FF88 per point scored on Lequesne's index. [ABSTRACT FROM AUTHOR]

The purpose of this paper is to describe the impact of exposure to influenza on hospitalizations and deaths in the elderly residents of long-term care facilities (LTCFs). An observational, longitudinal, prospective, multicenter, cohort study collected influenza and influenza-like cases, diseases, hospitalizations, and deaths of dependant elderly residents of French LTCFs during the 2004–2005 seasonal influenza epidemic. A total of 8,041 residents of 98 participating LTCFs were included. The mean age was 85 ± 9 years; 93% were vaccinated against influenza and 64% of the residents were exposed to influenza during the epidemic. Exposure to influenza increased both the all-cause risk of hospitalization (9.2% of the residents exposed vs. 7.4% of the residents not exposed) (relative risk, RR [95% confidence interval, CI] = 1.24 [1.05; 1.47]) and the all-cause risk of death (5.8% vs. 4.3%) (RR [95% CI] = 1.36 [1.10; 1.70]). Exposure to influenza increased the risks of death and hospitalization. Additional measures should be taken to avoid influenza exposure and apply recommendations more thoroughly in the particularly susceptible population of elderly LTCF residents. [ABSTRACT FROM AUTHOR]

In many sport disciplines the delivery of oxygen to muscles plays a critical role. Indeed, muscle performance declines during prolonged and intense activity as a consequence of the shift from the aerobic to the anaerobic metabolism with an increase of lactate. To enhance the aerobic capacity two alternatives may be used: increasing either the transport or the delivery of oxygen. In this setting, erythropoietin use is the practice of illicitly using a drug to improve athletic performances. In the present overview, old and newer erythropoietic stimulating molecules are described with a special emphasis on their potential side effects. Direct and indirect detection methods are briefly described with the aim of mentioning their roles and limits with regard to anti-doping strategies. [ABSTRACT FROM AUTHOR]

Purpose: To estimate the association between self-reported visual impairment and mortality. Methods: Two national surveys in community and institutionalized populations were combined. First, 2,075 institutions for children with impairments, adults with impairments aged persons, and psychiatric patients were selected randomly. The sample comprised 15,403 subjects of whom 14,603 (94.9%) were interviewed. Second, a random, stratified sample of 21,760 persons living in the community was selected, and 16,945 (77.9%) were interviewed. Types of impairment were identified by face-to-face interviews. Two years later, 14,497 subjects in institutions and 15,648 in the community were revisited. Data on death were obtained from either the National Register or households. Death rates were related to age, gender, and impairment. A logistic regression was performed including impairments, activities of daily living, age, gender, type of residence, and geographical area. Results: Strong, independent associations were found between particular impairments, institutional residence, activities of daily living, age, gender, and risk of death. Associations between mortality and type of impairment could be ranked as follows: motor (OR = 1.235), brain (OR = 1.552), low vision (OR = 1.681), speech (OR = 2.090), visceral (OR = 2.233) and blindness (OR = 2.262). Conclusions: Self-reported visual impairment is an independent factor associated with mortality. [ABSTRACT FROM AUTHOR]

The objective of this study was to estimate the unit costs of non-vertebral osteoporotic fractures in five European countries based on the results of the SOTI and TROPOS clinical trials in postmenopausal osteoporotic women. The information recorded in the Case Report Forms was used. The perspective of third party payers was adopted. Hip fracture unit cost was the highest. The ranges of costs among countries was narrow for hip from 8,346€ (Italy) to 9,907€ (France), but wider for other fractures: 890€ (Spain) to 2,022€ (Italy) for wrist, 1,167€ (Spain) to 3,268€ (Italy) for pelvis, 837€ (Spain) to 2,116€ (Italy) for sternum/clavicle, 565€ (Spain) to 908€ (France) for rib, 1,518€ (Spain) to 3,651€ (Belgium) for humerus, 1,805€ (Spain) to 3,521€ (Italy) for leg. The costs of those fractures should be considered when estimating the cost of osteoporosis. [ABSTRACT FROM AUTHOR]

Abstract: Objective: Analyse the performance of human papillomavirus testing with hybrid capture II® on liquid-based CYTO-screen® system for women diagnosed with atypical squamous cells of undetermined significance according to the age. Patients and methods: Were included all women diagnosed with atypical squamous cells of undetermined significance for whom human papillomavirus testing was performed and cytological and histological procedures were available over a follow-up period of 6 to 18 months. Results: Human papillomavirus testing was performed in 3,047 patients, and results were compared to cytological and histological follow-up diagnosis in 1,880 cases (61.7%). The sensitivity for diagnosing cervical intraepithelial neoplasia was 93.3% in women less than 30 of age and 89.7% in women more than 30 of age. Specificity was 44.9% in women less than 30 of age and 64.4% in women more than 30 of age. Likelihood ratios confirmed these results as they show a low discriminatory power in case of positive result specifically in women less than 30 of age but an excellent performance in case of negative result. Discussion and conclusion: The use of human papillomavirus testing after a diagnosis of atypical squamous cells of undetermined significance with the residual material of Cyto-screen®sant le mil system is a possible triage procedure to identify patients needing a colposcopy. Its specificity is better for women over 30. [Copyright &y& Elsevier]

Abstract: Objective. – The authors had for aim to describe the management of varicella and its complications in French ambulatory care. Methods. – A descriptive prospective national survey was carried out in France on patients visiting a random sample of French GPs and pediatricians (investigators) having diagnosed varicella. During an inclusion period of 4 months, the investigators enrolled all patients (adults–children) who presented with varicella or varicella related complications, and who had not previously visited the investigator for this episode. Three questionnaires were used to record the data. Results. – One thousand two hundred patients were enrolled by 393 physicians 75% of whom were GPs. Ninety-four percent of patients were children under 13 years of age (group I). The sex ratio (M/F) was 1.1. The mean age was 3.5 years in group I and 23.8 years in patients over 13 years of age (group II). The mean length of the varicella episode was about 10.7 days. Most patients were given a pharmaceutical prescription on inclusion, 1% were also prescribed medical procedures, 0.3% were given local treatment, and 0.09% underwent physical therapy sessions. A proportion of 12.6% of patients visited their physician twice or more for the same episode. Six group I children were hospitalized. Eighty-seven patients presented with at least one complication i.e. 7.8% (95%CI=6.3–9.3) of all episodes, mainly bacterial superinfections. Conclusions. – The rate of complications associated with varicella infection was higher than usually reported in France but in the same order of magnitude as in other developed countries. Bacterial superinfections were found to be the most frequent complications of varicella. [Copyright &y& Elsevier]

Aims: To estimate the risk of living in an institution and being visually impaired. Methods: Two national surveys were pooled: (1) 2075 institutions (for children or adults with handicaps, old people, and psychiatric centres) were selected randomly, in 18 predefined strata, from the French health ministry files. From these institutions, 15 403 subjects were selected randomly and handicap was documented by interview in 14 603 (94.9%) of them; (2) level of handicap was documented in a randomised, stratified sample of 356 208 citizens living in the community; from this sample, 21 760 subjects were further selected at random and 16 945 people were interviewed. Data on handicaps (visual, auditory, speech, brain, visceral, motor, and other) and activities of daily living (ADL) were extracted. The odds ratio (OR) of living in an institution was estimated, using stepwise logistic regressions with age, geographical area, handicaps, and ADL as co-variables. Results: Subjects in institutions, compared to those living at home, were, respectively, more often female (64.3% v 52.4%) and older (68.7 v 38.0 years); they more often had handicaps (ORs: speech, 6.59; brain, 10.17; motor, 8.86; visceral, 3.49; auditory, 2.66; other, 1.53); and were less often able to perform their ADL (46.2% v 97.1 %) without assistance. Below 80 years, blind people were more often in institutions (ORs 0.239 to 0.306); whereas in older people the association was reversed (OR: 3.277). Low vision was always significantly associated with institutional residence (ORs from 0.262 to 0.752). Conclusion: Visual handicap was associated with institutional residence. The link persisted after adjustment for known confounding factors. [ABSTRACT FROM AUTHOR]

Because abnormalities in redox balance cluster in type I diabetes families and the intracellular thiol redox status seems to modulate immune function, we aimed to investigate the relationship between oxidative stress and immunological features. We measured oxidative markers, serum proinflammatory cytokines, soluble cytokine receptors and subsets of peripheral blood lymphocytes (by varying combinations of CD4, CD8, CD23 or low-affinity IgE receptor, and CD25 or IL-2 receptor) from 38 type I patients, 76 low-risk (i.e. without underlying islet autoimmunity) non-diabetic first-degree relatives of diabetic patients, and 95 healthy subjects. In type I diabetes families, protein and lipid oxidation was confirmed by the presence of reduced sulphhydryl groups, increased advanced oxidation protein products, and increased plasma and erythrocyte malondialdehyde. Relatives had decreased counts of monocytes, of cells co-expressing CD23 and CD25 and of CD25+ cells in peripheral blood. Patients with TIDM had similar defects and, in addition, showed decreased counts of peripheral CD4+CD8+ lymphocytes and increased serum levels of soluble receptors for interleukin (IL)-6 and IL-2. Abnormal indicators of oxidative stress were related in part to immune abnormalities. In the whole study group, we found a correlation (multiple R 0·5, P < 0·001) of CD23+CD25+ cells with blood counts of monocytes, CD4+CD8+ cells, CD25+ cells, basal haemolysis and plasma levels of thiols. In type I diabetics, anti-GAD65 antibody levels were associated (multiple R 0·6, P = 0·01) positively with sIL-6R, negatively with duration of diabetes and CD23+CD25+ counts; plasma creatinine correlated positively (multiple R 0·6, P < 0·001) with both sIL-2R and tumour necrosis factor (TNF)- α concentration. Our study reports the first evidence that the oxidative stress observed in type I families is related to immunological hallmarks (decreased peripheral numbers of monocytes as well as cells bearing a CD4+CD8+, CD23+CD25+ and CD25+ phenotype) from which the involvement of some immunoregulatory mechanisms could be suspected. It remains to be elucidated the course of events culminating in the loss of physiological immune homeostasis and disease pathology. [ABSTRACT FROM AUTHOR]

Objective: To assess the cost effectiveness of emedastine, a new antihistamine, versus levocabastine in the treatment of acute allergic conjunctivitis (AAC) in Belgium, France, Germany, The Netherlands, Norway, Portugal and Sweden.Design and Setting: Randomised double-blind multicountry clinical trial followed by economic modelling from the treatment provider perspective.Patients: A total of 221 patients (109 emedastine, 112 levocabastine) with AAC were included.Methods: The clinical trial compared the efficacy and safety of emedastine 0.05% and levocabastine 0.05%, both twice daily, for 42 days, using ocular redness, itching, days without symptoms and clinical failure as outcome measures. The cost of first-line treatment failure, including visits, drugs and laboratory examinations, was established in each country from a panel of ophthalmologists and general practitioners. Full sensitivity analyses were conducted.Results: From day 7 to 42, patients treated with emedastine had less itching (p < 0.001) and less redness (p < 0.001). The failure rate was 10% less (p < 0.02) with emedastine and patients treated with emedastine had an incremental 8.5 days (p < 0.01) without symptoms. Emedastine and levocabastine were equally well tolerated. In all European countries, the cost of failure was lower with emedastine. Emedastine was found to be economically dominant relative to levocabastine, i.e. more effective and less expensive, in Belgium, Germany, Portugal and Sweden; in France, The Netherlands and Norway the incremental cost was low (less than 1 euro per additional symptom-free day).Conclusion: Through a model based on a randomised clinical trial and cost estimates of treatment failure derived from practitioner interviews, emedastine is a cost-effective treatment of AAC. [ABSTRACT FROM AUTHOR]

Objectives: To perform an evaluation from the societal perspective of the cost of treatment with enoxaparin sodium versus unfractionated heparin (UFH) in patients with unstable angina and non-Q wave myocardial infarction in France.Design: Four complementary cost-minimisation analyses based on the results of the Efficacy and Safety of Subcutaneous Enoxaparin in Non-Q wave Coronary Events (ESSENCE) international trial were conducted. We assessed differences in medical resource consumption and in duration of hospital stay in the whole study population (n = 3171) and for the French patients (n = 133).Results: Results were consistent for the study group as a whole and for the French subgroup. Among patients treated with enoxaparin sodium, there was a statistically significant reduction in the use of angiography and percutaneous transluminal coronary angioplasty (whole group study: p = 0.024 and 0.006, respectively) and a trend towards shorter lengths of hospital stay. The differences in angiography and angioplasty rates led to estimated average net cost savings with enoxaparin sodium of French Francs (FF)1555 per treated patient (whole study population) and FF9993 (French subgroup) [1996 values]. The analyses based on the duration of hospital stay resulted in estimated net cost savings with enoxaparin sodium of between FF1014 per treated patient (whole study population) and FF2804 (French subgroup).Conclusion: Our study confirmed earlier results which show that enoxaparin sodium is cost saving in the treatment of unstable angina. [ABSTRACT FROM AUTHOR]

Objective: To compare the 12-month cost-effectiveness of milnacipran in maintenance treatment of depression to that of medical follow-up without antidepressant. Method: A Markov model with transition probabilities from a double blind clinical trial demonstrating the prophylactic efficacy of milnacipran was used. Other parameters were obtained from published sources. Results: Base-case incremental cost for preventive treatment was 1,191 FF. It was reduced to 685 FF when using a 25% hospitalization rate in case of recurrence. Patients with a high initial response had extra cost of 191 FF and cost-utility was estimated to be 23,875 FF per QALY gained. For those patients, using a 25% hospitalization rate in case of recurrence, costs were lower at 1,174 FF and preventive strategy was dominating. Conclusion: Cost of maintenance therapy is partially balanced by the gain from recurrence prevention. It should be focused on patients with few residual symptoms or a high probability of hospitalization in case of recurrence. [ABSTRACT FROM AUTHOR]

Focuses on preparticipation screening (PPS) for the detection of cardiovascular abnormalities that may cause sudden death in competitive athletes. Recommendation of a PPS protocol by the American Heart Association; Factors that influence the efficacy of the screening program; Usefulness of 12 lead electrocardiograms for identifying cardiovascular disease in athletes.

There is growing evidence to show the effectiveness of physical exercise for multiple sclerosis (MS) patients. Aim of this study was to evaluate aerobic capacity, strength, balance, and the rate of perceived exertion (RPE) after exercise, in ambulatory patients with mild MS and matched control healthy participants. Seventeen MS patients aged 48.09 ± 10.0 years, with mild MS disability (Expanded Disability Status Scale: EDSS 1.5 to 4.5) and 10 healthy sedentary age matched (41.9 ± 11.2 years) subjects volunteered for the study. MS patients underwent medical examination with resting electrocardiogram, arterial blood pressure, EDSS, and Modified Fatigue Impact Scale-MFIS. Both groups also underwent physical assessment with the Berg Balance Scale, test (Berg), Six Minutes Walking Test (6MWT), maximal isometric voluntary contraction (MIVC) of forearm, lower limb, shoulder strength test, and the Borg 10-point scale test. The one-way ANOVA showed significant differences for MFIS (F1.19=9.420; p<0.01), Berg (F1.19=13.125; p<0.01), handgrip MIVC (F1.19=4.567; p<0.05), lower limbs MIVC (F1.19=7.429; p<0.01), and 6MWT (F1.19=28.061; p<0.01) between groups. EDSS, Berg test and Borg scores explained 80% of 6MWT variation. Mild grade EDSS patients exhibited impaired balance, muscle strength, and low self pace-6MWT scores, whereas RPE response after the exercise was similar to that of sedentary individuals. Both groups showed similar global physiological adjustments to exercise. [ABSTRACT FROM AUTHOR]

Patients andmethod: An observational study was carried out in an oncology department that had initiated an active anaemia management strategy using ESA (darbepoetin-alpha) in order to observe the resulting changes seen in the use of transfusions and to assess the effectiveness of this strategy in controlling anaemia in clinical practice. Data were gathered from medical files of all patients treated with ESA for anaemia during two successive periods of a year. The first period corresponded to the implementation of this strategy within the unit (from September 2006), and the second period (from April 2008) could be regarded as a phase of stable practice. Results: The percentage of patients treated with ESA increased slightly, from 23.3 to 26.8%, for the active group, which remained almost identical during the two periods (897-899 patients). The average number of ESA injections per patient decreased (3.21 compared to 2.88, NS). The number of transfusions reduced by about 19% across the two periods. Analysis of the effectiveness of treatment was carried out on a cumulative number of 339 patients, who received a continuous sequence of ESA injections during the same course of chemotherapy, with at least three injections of ESA. This corresponded to 205 patients in period one and 134 patients in period two. Effectiveness was defined as a function of the changes in Hb level (ΔHb) in three categories: 39.8% of patients were judged to have responded well (ΔHb ≥ 1 g/dl), 36.9% as having had an intermediate response (0 ≤ δHb < 1 g/dl) and if ΔHb < 0, they were classified as not responded (33.3%). Improvements in Hb levels during successive ESA injections were more significant for patients presenting with initially low Hb levels. Conclusions: The results obtained show that the effectiveness of darbepoetin-alpha observed in clinical practice is in agreement with that demonstrated in clinical trials, and confirms that treatment with darbepoetin-alpha substantially decreases the need for transfusions. [ABSTRACT FROM AUTHOR]

Abstract: Background: Bipolar disorder (BPD) is a disabling disease with high morbidity rates. An international (Spain, France) comparative study about hospitalizations and in-patient care costs associated with BPD I was performed. Centers were included if they had access to a database of computerized patient charts exhaustively covering a defined catchment area. Methods: Economic evaluation was performed by multiplying the average cumulated annual length of stay (LOS) of hospitalized bipolar patients by a full cost per day of hospitalization in each center to obtain the corresponding annual costs. Results: Hospitalization rates per annum and per 100,000 individuals (general population aged 15+) were similar between France (43.6) and Spain (43.1). There were only slight differences in relation to length of stay (LOS) per patient hospitalized with 18.1 days in Spain and 20.4 days in France. The overall estimated annual hospitalization costs were in the same order of magnitude after adjustment to an adult population of 100,000: €232,000 (Spain) and €226,500 (France). Mixed episodes had the longest LOS followed by depressive episodes, while manic episodes had the shortest ones. Mania was the most costly disorder representing 53.7% of annual BPD in-patient care costs. Conclusions: BPD I care requires large resources and frequent hospitalizations, especially during manic episodes. Depressive and mixed episodes require longer hospital stays than manic episodes. Out-patient costs should now be evaluated. [Copyright &y& Elsevier]

Objective: Regular physical activity is associated with a reduction of cardiovascular morbidity and mortality; however, evidence of unfortunate cardiovascular events accompanying elite sport involvement continues to accumulate. To date, no information is available on possible peculiarities of the cardiovascular risk profile in athletes. Design: The aim of this study was to evaluate plasma homocysteine levels in a group of athletes and to search for relationship with vitamin status and other metabolic variables in order to confirm the existence of a "sport-related hyperhomocysteinaemia" and to explain its clinical significance. The study population was composed of 82 athletes (59 male and 23 female) practising different sports and 70 healthy age-matched subjects (40 male and 30 female) as a control group. Besides the general clinical and analytical determinations, the assessed variables included homocysteine, folate, vitamin B12, total and high-density lipoprotein )HDL) cholesterol, lactate dehydrogenase (LDH), creatine kinase (CPK) and interleukin-6 (IL-6). Results: The prevalence of hyperhomocysteinaemia (>15 μmol/l) in athletes and controls was 47% and 15%, respectively. No correlation was found between homo- cysteine and any of the other investigated variables, in particular plasma folate, blood pressure, LDH, CPK, total and HDL cholesterol and IL-B. Conclusion: The results of this study confirm the existence of a sport-related hyperhomocysteinaemia which appears linked neither to the same variables found in the general population, nor to specific training-related variables. We suggest that it would represent an adaptation to training but the possibility of a secondary vascular damage cannot be excluded. [ABSTRACT FROM AUTHOR]

Background: The effectiveness of cardiovascular screening in minimising the risk of athletic Reid deaths in master athletes is not known. Objective: To evaluate the prevalence and clinical significance of ST segment depression during a stress test in asymptomatic apparently healthy elderly athletes. Methods: A total of 113 male subjects aged over 60 were studied (79 trained and 34 sedentary); 88 of them (62 trained and 26 sedentary) were followed up for four years (mean 2.16 years for athletes, 1.26 years for sedentary subjects), with a resting 12 lead electrocardiogram (ECG), symptom limited exercise ECG on a cycle ergometer, echocardiography, and 24 hour ECG Holter monitoring. Results: A significant ST segment depression at peak exercise was detected in one athlete at the first evaluation. A further case was seen during the follow up period in a previously "negative" athlete. Both were asymptomatic, and single photon emission tomography and/or stress echocardiography were negative for myocardial ischaemia. The athletes remained symptom-free during the period of the study. One athlete died during the follow up for coronary artery disease: he showed polymorphous ventricular tachycardia during both the exercise test and Holter monitoring, but no significant ST segment depression. Conclusions: The finding of false positive ST segment depression in elderly athletes, although still not fully understood, may be related to the physiological cardiac remodelling induced by regular training. Thus athletes with exercise induced ST segment depression, with no associated symptoms and/or complex ventricular arrhythmias, and no adverse findings at second level cardiological testing, should be considered free from coronary disease and safe to continue athletic training. [ABSTRACT FROM AUTHOR]

OBJECTIVE:: Nutritional status and lifestyle can have profound effects on health. To analyse behaviour patterns in population subgroups of public health importance, we compared lifestyle, dietary intake of energy and selected nutrients, and nutritional biomarkers of type 1 diabetes (T1DM) patients and nondiabetic first-degree relatives against control subjects with no family history of T1DM. DESIGN:: A cross-sectional study. SETTING:: Department of Internal Medicine, University of Pisa, Italy. SUBJECTS:: A total of 209 individuals including 38 type 1 patients, 76 relatives, and 95 healthy subjects. INTERVENTIONS:: We used the European Prospective Investigation of Cancer and Nutrition questionnaires to assess dietary intake and lifestyle. Anthropometric indices and nutritional biomarkers (such as plasma levels of albumin, iron, lipids, homocysteine, vitamin B9 and vitamin B12 as well as urinary outputs of nitrogen, sodium and potassium) were evaluated. RESULTS:: Emerging health issues:(1) In total, 45%of controls were overweight. Increasing age was associated with increasing body mass and decreasing activity in sport in front of an unchanged energy intake.(2) The distribution of energy sources was incorrect. The proportion of caloric intake derived from total fat and cholesterol did not match general guidelines. Total dietary fibre consumption was assessed to be adequate (25?g/day) in only 27%of all the participants.(3) Estimated daily intakes of water-soluble vitamin B9 and fat-soluble vitamin D and vitamin E were deficient in comparison with dietary reference intakes.(4) The prevalence of adoption and maintenance of healthful eating and physical activity habits was higher in women and T1DM patients (probably as a consequence of the medical educational intervention). On the contrary, supportiveness of the family in term of changing the undesirable behaviours at home seemed to fail. CONCLUSIONS:: This study provides first evidence indicating unhealthy dietary behaviours, which could even predispose to the development of diabetes and cardiovascular complications, in subjects living in Pisa. The combination of vitamin B9 and vitamin E deprivation could be deleterious for endothelial function, since these antioxidants have been implicated in the modulation of nitric oxide and eicosanoid signalling. SPONSORSHIP:: This study was supported by a grant from the Ministry of Education, University and Research, Italy.European Journal of Clinical Nutrition (2005) 59, 114-122. doi:10.1038/sj.ejcn.1602047 Published online 1 September 2004 [ABSTRACT FROM AUTHOR]

Objective: Recurrent infectious rhinitis (RIR) is a frequent disease among adults and constitutes an economic burden for National Sickness Funds (NSF) that might be prevented by immunostimulant therapy. Cost effectiveness of preventive methods should be documented. The aim of this study was to determine whether the cost of treating patients with ribosomal vaccine (Ribomunyl), an immunostimulant therapy, could be offset by the savings associated with avoided RIR episodes.Design and Setting: Using a 'piggy-back' approach, an economic analysis was conducted based on a placebo-controlled clinical trial of 327 patients with at least 3 episodes of RIR in the past year. Patients were recruited during September and October 1994 through 50 French and 2 Belgian specialists (ear, nose and throat; ENT) and were randomised to receive ribosomal vaccine or placebo for a 6-month period covering the entire winter season. Two economic perspectives were analysed: (i) the French NSF; and (ii) the patient (i.e., considering copayments which are not reimbursed by the NSF).Main Outcome Measures and Results: The placebo-controlled clinical trial demonstrated a significant decrease (p < 0.001) of more than 30% in the cumulative number of RIR episodes with ribosomal vaccine during the 6-month study period. In general, patients receiving the active treatment tolerated it well. Data were collected on the use of medical services (e.g. number of physician visits), antibacterial and other drug courses, as well as the number of sick-leave days for the study participant. Patients treated with ribosomal vaccine visited their general practitioner (GP) less frequently (mean reduction of 33%), had fewer days of antibacterial use (mean reduction of 3.5 days) and took fewer sick-leave days (mean reduction of 6.3%).Conclusions: Overall, the cost of prevention with ribosomal vaccine was offset by the savings to both the French NSF and to patients (in terms of out-of-pocket expense). Indeed, ribosomal vaccine was deemed to be a cost-saving agent in the prevention of RIR in the French healthcare setting, provided that it is prescribed only for patients who are expected to develop at least 2 episodes of RIR in the coming year. [ABSTRACT FROM AUTHOR]

The risk of late-occurring deep vein thrombosis and pulmonary embolism after total hip replacement persists for at least 3 weeks after hospital discharge. Recent clinical trials have demonstrated that prolonged prophylaxis with enoxaparin, a low-molecular-weight heparin (LMWH), significantly reduces this risk. We used a decision-analysis model to determine the incremental outcomes associated with the routine use of such prophylaxis, administered during hospitalisation for total hip replacement and for 3 weeks after discharge, instead of short term prophylaxis administered only during hospitalisation. For a hypothetical cohort of 100 000 patients undergoing hip surgery, prolonged LMWH prophylaxis saved between 601 and 783 additional lives compared with prophylaxis stopped at discharge. This was obtained at a net direct marginal cost ranging from 1118 to 1300 French francs (F) per patient. The cost-effectiveness ratio ranged from F11 158 to F34 591 per life-year saved and from F23 532 to F35 268 per venous thromboembolic event (routinely diagnosed and treated) avoided. Prolonged LMWH anticoagulant prophylaxis with enoxaparin is more effective in routine practice after elective hip surgery than conventional short term perioperative prophylaxis in terms of the number of deaths or thromboembolic events avoided. Such prophylaxis also appears to be clearly cost effective, using French cost data. [ABSTRACT FROM AUTHOR]

The risk of late-occurring deep vein thrombosis and pulmonary embolism after total hip replacement persists for at least 3 weeks after hospital discharge. Recent clinical trials have demonstrated that prolonged prophylaxis with enoxaparin, a low-molecular-weight heparin (LMWH), significantly reduces this risk. We used a decision-analysis model to determine the incremental outcomes associated with the routine use of such prophylaxis, administered during hospitalisation for total hip replacement and for 3 weeks after discharge, instead of short term prophylaxis administered only during hospitalisation. For a hypothetical cohort of 100 000 patients undergoing hip surgery, prolonged LMWH prophylaxis saved between 601 and 783 additional lives compared with prophylaxis stopped at discharge. This was obtained at a net direct marginal cost ranging from 1118 to 1300 French francs (F) per patient. The cost-effectiveness ratio ranged from F11 158 to F34 591 per life-year saved and from F23 532 to F35 268 per venous thromboembolic event (routinely diagnosed and treated) avoided. Prolonged LMWH anticoagulant prophylaxis with enoxaparin is more effective in routine practice after elective hip surgery than conventional short term perioperative prophylaxis in terms of the number of deaths or thromboembolic events avoided. Such prophylaxis also appears to be clearly cost effective, using French cost data. [ABSTRACT FROM AUTHOR]