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F Fagnani

Publications and source records attributed to F Fagnani.

At least 37 records · Page 2Linked to original sources

Oral theophylline supplementation and high-intensity intermittent exercise.

AIM: The present study was carried out to investigate whether oral theophylline supplementation exerts an ergogenic effect during intermittent high-intensity exercise. METHODS: Ten healthy subjects undertook intermittent exercise (1 min cycling at 120% of VO(2max) with 3 min of recovery until exhaustion). The exercise test was repeated twice, 1 week apart. On each occasion, the subject ingested, in a double blind setting, either theophylline (4.5 mg/kg) or placebo 90 min before commencing the exercise test. RESULTS: Three subjects could not complete both trials due to nausea and dizziness after theophylline had been administered. Time to exhaustion in the remaining subjects was slightly increased after theophylline administration (55.9+/-6 min vs 59.3+/-5.9 min; p<0.05). CONCLUSION: Present data indicate that oral theophylline supplementation delays fatigue onset during intermittent high-intensity exercise. The effect, although statistically significant, does not appear to be marked. The possibility of occurrence of negative side effects and the evidence for its ergogenic potential suggests the necessity to include theophylline in the International Olympic Committee (IOC) World Antidoping Agency (WADA) list as a banned or restricted substance.

Administration, Oral↗

Cost of care for inpatients with community-acquired intra-abdominal infections.

Few studies have assessed the actual costs associated with failure of initial empiric antibiotic therapy administered to patients with community-acquired intra-abdominal infections. The goals of this study were (i) to determine the frequency of unsuccessful initial empiric therapy in a real-world setting and (ii) to determine the associated impact on medical costs. Thus, a retrospective chart review was performed at four acute-care university hospitals in France. A total of 292 patients hospitalized for community-acquired intra-abdominal infection were included. The mean age of the cohort was 51 years, and 42% of the patients were female. The most commonly administered empiric regimens were intravenous amoxicillin/clavulanate alone (69 patients) or in combination with other antibiotics ( n=87) and piperacillin/tazobactam alone ( n=24) or in combination ( n=48). Other regimens included broad-spectrum penicillin, cephalosporins, and fluoroquinolones administered alone or in combination ( n=64). Empiric therapy was successful in 189 (65%) patients and unsuccessful in 103 (35%). Among the 292 patients with community-acquired infection, 15 died of the infection, 8 required reoperation and 80 required second-line antibiotic therapy. Patients with unsuccessful initial empiric therapy had significantly more parenteral antibiotic days (10.3 vs. 7.6 days) and a longer length of stay (16.2 vs. 12.8 days) compared to those with successful initial empiric therapy. A better selection of initial empiric antibiotic therapy may significantly influence the medical costs associated with patients who are hospitalized with community-acquired intra-abdominal infections.

Adult↗

Antithrombotic therapy is associated with better survival in patients with severe heart failure and left ventricular systolic dysfunction (EPICAL study).

BACKGROUND: In patients with congestive heart failure (CHF), clinical trials have demonstrated the benefit of a number of drugs on morbidity and mortality. Nevertheless so far, there is no published controlled study of long-term antithrombotic therapy in patients with CHF. The aim of this work was to identify the relationship between cardiovascular drug use, especially antithrombotic therapy, and survival of CHF patients in current clinical practice, using an observational, population-based database. METHODS: The EPICAL study (Epidémiologie de l'Insuffisance Cardiaque Avancée en Lorraine) has identified prospectively all patients with severe CHF in the community of Lorraine. Inclusion criteria were age 20-80 years in 1994, at least one hospitalisation for cardiac decompensation, NYHA III/IV HF, ventricular ejection fraction < or =30% or cardiothoracic index > or =60% and arterial hypotension or peripheral and/or pulmonary oedema. A total of 417 consecutive patients surviving at hospital discharge were included in the database. The average follow-up period was 5 years. Univariate Cox models were used to test the relationship of baseline biological and clinical factors to survival. Cardiovascular drug prescriptions were tested in a multivariate Cox model adjusted by other known predictive factors. RESULTS: Duration of disease >1 year, renal failure, serum sodium > or =138 mmol/l, old age, serious comorbidity, previous decompensation, high doses of furosemide and vasodilators use were independently associated with poor prognosis at 1 and 5 years. Oral anticoagulants, aspirin, lipid lowering drugs and beta-blockers use were associated with better survival. There was no interaction between aspirin and angiotensin converting enzyme inhibitor use on survival. CONCLUSION: Antithrombotic therapy was associated with a better long-term survival in our study population of severe CHF. These results together with other previously published circumstantial evidence urge for a prospective, controlled and randomised trial specifically designed to evaluate optimal oral anticoagulants and aspirin in patients with congestive heart failure.

Adrenergic beta-Antagonists↗

[Evolution of medical practice in the care of anemia amd the use of erythropoietin in chronic renal insufficiency hemodialysis in the past six years].

In order to analyze changes in anemia management in the hemodialysis patients, a retrospective survey was performed in 1999 on a representative French sample of patients in hemodialysis treated by EPO since 1992, 1994, 1996, and 1998 respectively. 368 patients were enrolled in 97 centres. At treatment initiation, some patients characteristics have significantly changed: the percentage of type 2 diabetic patients has increased marquedly from 4.5% in 1992 to 22.1% in 1998. The mean time lag between dialysis and EPO treatment initiation has decreased from 3.3 years to 0.9 on the 6-year period. Lastly, the mean hemoglobin level has increased from 73.7 to 78.5 g/l. No significant evolution in the EPO protocol was observed at the initiation as well as in the maintenance phase. An average percentage of 33.7% of patients were treated in i.v. route at initiation with a mean posology of 105.2 IU/kg (respectively 91.4 in s.c.). In the first year of follow-up, the overall mean posology was 84 IU/kg. In conclusion, this survey suggests that anemia management has been optimized over the last 6 years follow-up, including an earlier initiation of EPO treatment and a higher target of hemoglobin while EPO needs were reduced in the same time.

Anemia↗

Blood levels of total homocysteine in patients with type 1 diabetes (with no complications, diabetic nephropathy and/or retinopathy) and in their non-diabetic relatives.

BACKGROUND AND AIM: It has been reported that plasma homocysteine (Hcy) levels in type 1 diabetes (T1DM) patients without renal involvement are higher, similar to or lower than those in healthy controls. METHODS AND RESULTS: We measured plasma Hcy in 60 controls, 79 type 1 diabetics (23 with retinopathy, 22 with nephropathy) and 73 non-diabetic relatives of 30 probands. The female controls had lower levels than their male counterparts: geometric mean 10.5 vs 13.6 mumol/L, p < 0.001. Among the controls, smokers (n = 20) and ex-smokers (n = 12) had higher Hcy levels than non-smokers (n = 28): 13.2 and 13.2 vs 10.9 mumol/L, p < 0.01. Among the diabetics, high plasma Hcy levels were associated with male gender: 11.9 vs 9.1 mumol/L in women, p < 0.01. The patients without complications had higher plasma glucose and hemoglobin A1c (HbA1c) levels (p < 0.001), and lower plasma Hcy (9.2 mumol/L vs 12.2, p < 0.01) and uric acid levels (p < 0.05) than the controls. The patients with nephropathy and higher levels of Hcy (13.0 mumol/L vs 9.0, p < 0.05), and different levels of creatinine (p < 0.01), uric acid (p < 0.01), fibrinogen (p < 0.05), and urinary albumin (p < 0.001) than those with retinopathy. There was no difference in Hcy levels between the patients' relatives and the controls: 11.9 mumol/L in siblings vs 11.6 mumol/L, 13.5 mumol/L in parents vs 12.1 mumol/L. In the control group, plasma Hcy levels were associated with age, gender and smoking; among the diabetics, they correlated with age, gender, smoking, and plasma creatinine and lipoprotein (a) levels. CONCLUSIONS: 1) male gender and smoking are associated with high Hcy levels in healthy people; 2) plasma Hcy levels are lower in T1DM patients than in healthy people (glomerular hyperfiltration and accelerated hepatic transsulfuration?); 3) high Hcy levels are associated with diabetic nephropathy and plasma creatinine levels; and 4) non-diabetic first-degree relatives of type 1 diabetics have normal plasma Hcy concentrations.

Adult↗

Economic analysis of adjuvant therapy with interferon alpha-2a in stage II malignant melanoma.

Using the trial demonstrating that interferonalpha-2a (IFNalpha-2a) is efficacious as adjuvant therapy in stage II melanoma, we evaluate its outcomes and economic consequences. Using rates observed in the 5-year trial and published figures, survival and Q-TWIST (Time Without Symptoms and Toxicity) were extrapolated to a 10-year and lifetime horizon. Cost analysis was performed using the trial's data, published literature and experts' opinions from the perspective of the French Sickness Funds. Patients in the IFNalpha-2a-group have an additional 0.26 years in life-expectancy over a 5-year time period (P=0.046), 0.67 years over a 10-year period and 2.59 years over a lifetime. Cost per life-year-gained was estimated at approximately 14400 after 5 years, 6635 after 10 years and 1716 over a lifetime. Assuming that there is an improvement in disease-free survival only, cost is 26147 per Q-TWIST. Cost-effectiveness of IFNalpha-2a in stage II melanoma compares favourably with estimates for widely used therapies in the oncological field.

Adult↗

[Can donor insemination be optimised?].

OBJECTIVE: To compare the different donor insemination technics. MATERIAL AND METHOD: Analysis of the published studies about donor insemination which value the effectiveness of Intra Cervical Insemination (ICID) and Intra Uterine Insemination (IUID), the interest of ovulation induction, the possible complications, and the cost-effectiveness ratio. RESULTS: The meta-analysis of the Cochrane data base (10 comparative studies IUID versus ICID, 2568 donor insemination cycles) lead to a pregnancy rate per cycle (PRC) 17.77% with IUID versus 7.68% with ICID. The odds ratio is 2.63 (CI from 1.85 to 3.73). With these PRC, the direct cost per evolutive pregnancy is 54,780 F with ICID and 25,675 F with IUID. CONCLUSION: If it is possible to propose ICID to patient with an excellent regularity of ovulation. IUID with ovulation induction by gonadotropins is today the gold standard, and more especially as the law restrict the number of donor inseminations. Indeed, the IUID is two or three times more effective than ICID, consume the half of sperm straws, use a semen of moderate quality, there is no complication provided that the cycle is cancelled if there is more than two mature follicles and the cost-effectiveness ratio is greatly in favour with IUID.

Cervix Uteri↗

Cost effectiveness of emedastine versus levocabastine in the treatment of allergic conjunctivitis in 7 European countries.

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.

Benzimidazoles↗

[Hepavir, the first observational study of one cohort of patients treated with alpha-2a interferon, monotherapy. Evaluation of asthenia and its social consequences].

OBJECTIVES: The aim of this observational study in patients with chronic hepatitis C and treated with interferon alpha-2a was to assess 1) monitoring in everyday practice, 2) the acceptability of treatment and 3) the intensity of fatigue. METHODS: Three hundred and fifty four patients were enrolled by physicians in both teaching and general hospitals, or private practice. Before treatment, clinical, epidemiological, and virological data were collected as well as a self-evaluation of fatigue using a visual analogic scale. Clinical follow-up was assessed every 3 months during treatment and 6 months after the end of treatment and included an evaluation of fatigue and the number of workdays missed due to sickness. RESULTS: Two hundred and nineteen men and 135 women, mean age 45 +/- 13, were included. The epidemiological, histological and virological features of this group were similar to those patients usually treated for chronic hepatitis C. Before treatment, the mean measurement of fatigue was 41 on a scale from 0 (perfect form) to 100 (exhausted). Fatigue was unrelated to age, source of infection, biological activity, or histological score. It worsened in patients who stopped interferon after 3 or 6 months, but was stable in patients who continued treatment for 12 months. Fatigue decreased after the end of treatment and was unrelated to treatment response. The need to stop work was strongly related to the intensity of fatigue and the number of workdays missed due to sickness represented nearly two months out of three in 25% of active patients during the first quarter and in 15% of patients thereafter. 61% of patients self-injected interferon (mainly previous drug users) whereas 30% of patients used nurse care throughout treatment. CONCLUSION: This study not only provides a realistic evaluation of fatigue in patients with chronic hepatitis C, before, during and after treatment, but also highlights its social and economic consequences. It shows the need for further cost-effectiveness studies on new therapeutic strategies using combined treatments.

Absenteeism↗

Obesity morbidity and health care costs in France: an analysis of the 1991-1992 Medical Care Household Survey.

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. International Journal of Obesity (2000) 24, 151-155

Adolescent↗

The contributing factors to medical cost of epilepsy: an estimation based on a French prospective cohort study of patients with newly diagnosed epileptic seizures (the CAROLE study). Active Coordination of the Longitudinal Observational Network in Epilepsy.

Epilepsy is a common neurological condition with significant resource implications. An estimation was performed in France of the direct medical cost of patients presented with newly diagnosed seizures and followed during the first two years after diagnosis. This estimation was based on the service utilization data collected from French prospective cohort study (CAROLE: 1942 patients enrolled). Costs were estimated in a societal perspective in 1998 value. The impact on the costs of different factors like age, aetiologic categorization and severity of seizures (type and number of seizures), and treatment by anti-epileptic drugs (AEDs) was analysed. The mean annual direct epilepsy-related costs per patient were estimated to be 14 305 F and 3766 F for the first and the second year of follow-up respectively, 68% and 40% of the costs were devoted to inpatient care. Costs during the first year were highly sensitive to aetiologic categorization of seizures at inclusion and to other clinical parameters. Second-year costs had a much lower variance and were sensitive to frequency of seizures and the fact of being treated or not by AEDs. Our data emphasize the importance of seizure control as means of reducing the costs of epilepsy especially during the first year of follow-up.

Adolescent↗

Economic evaluation of enoxaparin sodium versus heparin in unstable angina. A French sub-study of the ESSENCE trial.

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.

Angina, Unstable↗

[Medical resources consumption of type 2 diabetics in France in 1998].

The research objective of CODE-2 study was to estimate the total direct medical resources use of type 2 diabetes in France and in Europe. Only French data are provided in this paper. Total medical resources consumption of type 2 diabetics on a 6 months retrospective period were collected through a national practitioner survey (including both general practitioners and diabetology/endocrinology specialists). This survey was completed for 751 patients. Data collected were then extrapolated to be representative of all type 2 diabetics in France. Average medical resources consumption of a type 2 diabetic per year is 3 350 US$ (1 US$ =6FF). This figure is a minimum because some costs were underestimated in the study. Extrapolated to all diagnosed and treated type 2 diabetics in France, this expenditure is 4.3 billion US$ and accounts for 3.8 % of the total medical resources consumption in France (prevalence of type 2 diabetes reaches 2.5 % in the general population). Among this consumption, 24.1 % is directly related to diabetes, 26.7 % to potential related diabetes complications and 49.2 % to other diseases. Time since diagnosis, current treatment type and complications are the main factors which increase such consumption. CODE-2 study reveals the high level of medical resources consumption associated with type 2 diabetes complication. It confirms that more efficient therapeutical strategies are needed to avoid these complications.

Costs and Cost Analysis↗

Managing type 2 diabetes in France: the ECODIA survey.

In order to describe the profile and medical management of type 2 diabetes patients in France, a descriptive cross-sectional survey was conducted in 1999 among a national random sample of 311 general practitioners and 51 specialists. A practitioner questionnaire was designed to collect information on a representative sample of 4,119 patients presenting with type 2 diabetes. Data collected included demographic and clinical information and a full description of diabetes management over a 6-month retrospective period. Over 50% of the patients were more than 67 years old; 54% were male. Diabetes had been diagnosed 8.9 years earlier on average, most frequently (73%) during a visit not related to diabetes' symptoms or complications. 42% of patients had a BMI > or =30 kg/m(2), 46% were hypertensive (BP > 140-80 mmHg), 53% had a LDL-Cholesterol over 1.3 g/l. Overall, 33% of patients had at least one diabetic complication. 60% of patients had had at least one HbA1c dosage in the last 6 months. Among them, 31% had a HbA1c level over 8% and 35% between 6. 5% and 8%. 85% of patients were treated with oral anti-diabetic drugs, 9.5% with diet and exercise only and 5% with insulin. Sulfonylureas were the most commonly prescribed anti-diabetic agent, either alone or in combination. This survey confirms that the management of patients with type 2 diabetes is still often inappropriate in France despite recent progress. Improved disease management and monitoring is required in France as in other developed countries.

Aged↗

Comparison of the cost-effectiveness of milnacipran (a SNRI) with TCAs and SSRIs: a modeling approach.

A simulation model based on the theory of clinical decision analysis was used to compare outcomes and costs when treating patients with major depressive episodes using either a selective serotonin re-uptake inhibitor (SSRI) or a tricyclic antidepressant (TCA), in comparison with milnacipran (a serotonin), and a norepinephrine re-uptake inhibitor (SNRI). The clinical data used were taken from published meta-analyses. This analysis supports: (1) a comparable efficacy of milnacipran and TCA with a better tolerance; and, (2) an advantage of milnacipran over SSRI for efficacy with a comparable tolerance. Based on these findings, a decision tree was constructed with the assistance of a panel of psychiatrists in order to provide a model of usual clinical practice. Estimates not available from clinical studies were obtained either from literature analysis or from the panel. Economic appraisal was performed according to the viewpoint of the French national sickness fund (sécurité sociale), and expenditure assessment was limited to direct costs (hospitalizations, antidepressant medications, visits, and laboratory tests). The results suggest that milnacipran is a cost-effective alternative: the expected cost of treatment per depressive episode is lower than either a French representative panel of TCAs (a saving of 288 FF), or SSRIs (a savings of 961 FF). The expected length of clinical remission is slightly higher than comparators. The robustness of these findings was supported by sensitivity analyses.

Adrenergic Antagonists↗

[Epidemiology, management and costs of type 2 diabetes in France in 1998].

Almost 10 years after the Saint Vincent declaration, a large effort was undertaken in France to improve medical care of type 2 diabetes and to limit the dreadful complications of this pathology. As expert recommendations grow in number, it appears necessary to update knowledge on the epidemiological, medical care, and cost aspects of this illness in France. In this aim, a systematic review of the medical and economic literature on type 2 diabetes was performed. Prevalence of type 2 diabetes probably reaches 2.2% in the general population, which represents 1.3 million people in France. Among these people, almost 60% are overweighted, 50% suffer high blood pressure and 30% have a treated dyslipaemia. Coronary pathologies concern 20% to 30% of type 2 diabetes patients, neuropathies 10% to 30% and ocular problems 10% to 35%. Medical care consumption of type 2 diabetes patients probably represents almost 20,000 FF per patient and per year, i.e., twice the average medical care consumption in the French population. Yet, these estimates should be considered with caution since a lot of uncertainty remains on the epidemiological, medical care, and cost aspects of type 2 diabetes in France. As diabetes has become a national public health priority, it is important to initiate new studies to have precise indicators in these different fields.

Aged↗