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Biomedical subjects

G Bouvenot

Publications and source records attributed to G Bouvenot.

At least 19 recordsLinked to original sources
PubMed2005

Total joint replacement of hip or knee as an outcome measure for structure modifying trials in osteoarthritis.

OBJECTIVE: The Group for the Respect of Ethics and Excellence in Science (GREES) organized a working group to assess the value of time to joint surgery as a potential therapeutic failure outcome criterion for osteoarthritis (OA) of the hip or knee in the assessment of potential structure modifying agents. METHODS: PubMed was searched for manuscripts from 1976 to 2004. Relevant studies were discussed at a 1-day meeting. RESULTS: There are no accepted guidelines for 'time to' and 'indications for' joint replacement surgery. A limited number of trials have examined joint replacement surgery within the study population. Several parameters, particularly joint space narrowing (interbone distance), correlate with surgical intervention. However, at the level of the knee, none of the parameters have positive predictive value for joint replacement surgery better than 30%. In contrast, lack of significant joint space narrowing has a strong negative predictive value for joint replacement surgery (>90%), that remains after controlling for OA pain severity. CONCLUSION: At this time, GREES cannot recommend time to joint surgery as a primary endpoint of failure for structure modifying trials of hip or knee OA-as the parameter has sensitivity but lacks specificity. In contrast, in existing trials, a lack of progression of joint space narrowing has predictive value of >90% for not having surgery. GREES suggests utilizing joint space narrowing (e.g., >0.3-0.7 mm) combined with a lack of clinically relevant improvement in symptoms (e.g., >/=20-25%) for 'failure' of a secondary outcome in structure modifying trials of the hip and knee.

Antirheumatic Agents↗
PubMed2004

Delivering generics without regulatory incentives? Empirical evidence from French general practitioners about willingness to prescribe international non-proprietary names.

France presents a unique situation in which the take-off of a generic drug market depends, out of regulatory incentives, on whether physicians choose a prescription method (international non-proprietary names, INN) that can lead to the delivery of these drugs and on whether patients accept them. This paper is aimed at pointing out factors explaining general practitioners' (GPs') willingness to prescribe in INN through data collected from a South-Eastern France representative sample of 600 GPs in March 2002. The main results shed light on the key-role played by GPs' information about drugs and the source which they take it from, by GPs' volume of services and caseloads, and slightly by socio-economic characteristics of patients.

Adult↗
PubMed2004

Time dependent risk of gastrointestinal complications induced by non-steroidal anti-inflammatory drug use: a consensus statement using a meta-analytic approach.

OBJECTIVES: To provide an updated document assessing the global, NSAID-specific, and time dependent risk of gastrointestinal (GI) complications through meta-analyses of high quality studies. METHODS: An exhaustive systematic search was performed. Inclusion criteria were: RCT or controlled study, duration of 5 days at least, inactive control, assessment of minor or major NSAID adverse effects, publication range January 1985 to January 2003. The publications retrieved were assessed during a specifically dedicated WHO meeting including leading experts in all related fields. Statistics were performed conservatively. Meta-regression was performed by regressing NSAID adjusted estimates against study duration categories. RESULTS: Among RCT data, indolic derivates provided a significantly higher risk of GI complications related to NSAID use than for non-users: RR = 2.25 (1.00; 5.08) than did other compounds: naproxen: RR = 1.83 (1.25; 2.68); diclofenac: RR = 1.73 (1.21; 2.46); piroxicam: RR = 1.66 (1.14; 2.44); tenoxicam: RR = 1.43 (0.40; 5.14); meloxicam: RR = 1.24 (0.98; 1.56), and ibuprofen: RR = 1.19 (0.93; 1.54). Indometacin users had a maximum relative risk for complication at 14 days. The other compounds presented a better profile, with a maximum risk at 50 days. Significant additional risk factors included age, dose, and underlying disease. The controlled cohort studies provided higher estimates: RR = 2.22 (1.7; 2.9). Publication bias testing was significant, towards a selective publication of deleterious effects of NSAIDs from small sized studies. CONCLUSION: This meta-analysis characterised the "compound" and "time" aspects of the GI toxicity of non-selective NSAIDs. The risk/benefit ratio of such compounds should thus be carefully and individually evaluated at the start of long term treatment.

Aged↗
PubMed2003

[Survey on the treatment of hospitalised community-acquired lower respiratory tract infections].

OBJECTIVES: The assessment of treatment habits regarding community-acquired lower respiratory tract infections and comparison with current national recommendations. METHOD: Prospective survey of treatment habits. Patients hospitalised for community-acquired pneumonia in the department of internal medicine, the department of neurology and the department of respiratory diseases (127 beds) at the Sainte-Marguerite Hospital in Marseilles were included. We studied the socio-economical context, the presence of severity factors, the analysis of risk factors, the antibiotic treatments prescribed (type, route of administration, duration) and the outcome of the patients. RESULTS: From November 2001 to February 2002, 98 patients with community-acquired pulmonary infections were included (61 men with a mean age of 72.5 years). The treatment of these patients conformed to guidelines in 79 cases. In 19 cases, the prescription did not conform (unjustified bi-therapy in 8 patients; absence of bi-therapy in suspected cases of intra-cellular bacteria in 4 patients; insufficient dose in 2 patients; and non-adapted antibiotherapy in 5 patients). CONCLUSION: In the study conditions, the management of community-acquired pneumonia in the hospital most often conformed to current guidelines. Nevertheless, efforts made for initial and continued medical training together with the wide circulation of the guidelines must be continued.

Adult↗
PubMed2003

[Willingness to prescribe by international non proprietary names: general practitioners attitudes in South East France in 2002].

OBJECTIVES: To evaluate the willingness, reasons and perceived obstacles to prescription by international non-proprietary name (INN) among general practitioners (GPs) in private practice. Method A panel of private GPs practicing in South-eastern France was surveyed twice, 2 months before and 5 months after a new contract between the National Health Insurance system and GP associations (5 June 2002). The panel was constructed with a random sampling approach stratified according to age, sex, and size of the urban unit. RESULTS: Between March-April and November-December 2002, the percentage of GPs willing to prescribe according to INN rose from 76.2% to 89.7%. These physicians reported that their principal reasons for such prescription were the June agreement and concern about the finances of the Health Insurance system. The principal obstacles they mentioned were the complexity of prescription by INN (66%), lack of appropriate information and tools (47%), and patient reticence (41%). CONCLUSION: More effort must be devoted to providing adequate information to patients and GPs. GPs need better training, information, and tools to help transform their willingness into action.

Adult↗
PubMed2001

[Diagnostic and therapeutic management of urinary infections. Survey in the medical services of the hospitals south of the Marseille Hospital Center].

OBJECTIVE: The aim of this prospective study was to observe diagnostic and antibiotic prescribing practices in urinary tract infection disease (UTID) in comparison with available guidelines. PATIENTS AND METHODS: We included all patients hospitalized in four medical wards of the Sainte-Marguerite Hospital in Marseille France who suffered from UTID. RESULTS: During the study period, 60 cases of UTID were observed, 29 were community-acquired and 31 were nosocomially-acquired. Management of uncomplicated UTID, the most frequent type (47/60 cases), showed considerable divergence between practices and guidelines. Not in keeping with the guidelines, urinalysis reagent strips were only used for 3 of the 47 cases. Furthermore, broad-spectrum antibiotics were prescribed as the first line treatment in more than 70% of the patients whereas only half of these prescriptions were warranted according to the guidelines. For complicated UTID however (13 cases) diagnostic and antibiotic prescribing practices were globally in accordance with the guidelines. CONCLUSION: This survey points out the divergence between guidelines and real management of UTID in hospitals. Clinical practices should be revisited to be in agreement with guidelines. Drafting antibiotic prescription guides explaining UTID management would be helpful for training future physicians.

Adolescent↗
PubMed2001

[How to prevent drug therapy risk].

PURPOSE: Therapeutic risk is largely foreseeable and can also largely be avoided. The art of prescription consists of favoring the beneficial effect of the medicament while taking all useful precautions to minimize undesirable effects. CURRENT KNOWLEDGE AND KEY POINTS: The appropriate method is correct use of the medicament at the collective and individual level. This is based on respect of reference systems and firstly on the particulars of the marketing license and the summary of the characteristics of the product, which provide validated knowledge concerning the medication. However, these may also be gray areas, insufficient updating, and insufficiently clear and concrete information on the expected therapeutic benefit as opposed to the pernicious effects feared. It is also based on opposing medical references, which attract attention to dangerous prescription practices. Moreover, for an individualized prescription it is necessary to take into account the actual patient, here and now, and not only the standard patient of clinical trials. Prescription priority must also be organized to favor indispensable medications only. In some cases drug monitoring based on personalized pharmacokinetics should be performed. Monitoring and informing of the patient must be strict for maximum safety; however, this is never complete. In this connection, lack of hindsight, premature enthusiasm, and falsely reassuring surveillance should be taken into account, particularly where undesirable effects not dependent on dosage are concerned. FUTURE PROSPECTS AND PROJECTS: Health education for the public, improved training of health staff as concerns iatrogenic effects and, shortly, computerized risk prevention with suitable software and data banks, systematic reviews and meta-analyses of therapeutic safety will help provide the patient with improved protection. This constitutes a major scientific, economic and ethical challenge for our societies.

Drug Monitoring↗
PubMed2001

[Reflections on some methodological errors in the evaluation of drugs. Ten years experience at the National Marketing Authorization Commission].

A ten year experience at the national french marketing authorization committee has permitted to notice the most commonly methodological errors in the field of clinical research and, particularly, in the dossiers for drug approval: a frequent insufficient sample size resulting in lack of statistical power, an unsatisfactory optimal dosing research, a misuse of the so-called surrogate markers, an erroneous opinion about the meaning of the p value, an abusive claim for equivalence in non significant superiority trials, a misuse of unadjusted multiple comparisons and too much confidence in subgroup analysis results.

Bias↗
PubMed2000

[Questionnaire on venous thromboembolism prevention by low molecular weight heparin in medical environment].

OBJECTIVE: The aim of this prospective study was to observe the prescription of low-molecular weight heparin (LMWH) for the prophylaxis of venous thromboembolic disease in medical patients. METHODS: We included all the patients on LMWH prophylaxis in 5 medical departments of Sainte-Marguerite Hospital in Marseille. The study described the reasons for this prophylaxis, the thrombotic risk, the follow-up quality and the side-effects. RESULTS: During four months, 189 (14.3%) of 1317 medical patients have received a prophylaxis with LMWH; sixty one per cent of them were older than 70 years. Thrombotic risk as measured with Thilly's score was low in 50 patients (26%), moderate in 81 patients (43%), high in 58 patients (31%). Platelet count follow-up was optimal in 88 patients (47%). A decrease of platelet count over 30%, reaching less than 100 G/l, was recorded in 4 patients. A venous thrombosis was diagnosed clinically in one patient. Two patients had an overt severe bleeding. A serious hidden bleeding was suspected in 11 patients. CONCLUSION: LMWH were frequently prescribed for the prophylaxis of venous thromboembolic disease in medical patients. Most of these patients were over 70 years of age. Platelet count follow-up was in accordance with guidelines in less than half of the patients. Bleedings were not rare on this treatment. The present work suggests that a precise thrombotic risk assessment is needed before the onset of this therapy and that the association with aspirin should be careful.

Adolescent↗
PubMed2000

[Anti-TNF-alpha monoclonal antibodies in the treatment of rheumatoid arthritis].

INTRODUCTION: Current slow-acting anti-rheumatic drugs available for rheumatoid arthritis can fail for certain severe cases; some are used empirically. Improvements in our knowledge of its pathogenesis and advances in molecular biology have made it possible to develop partially selective immunotherapy approaches. CURRENT KNOWLEDGE AND KEY POINTS: Tumor necrosis factor-alpha (TNF-alpha) is a critical inflammatory mediator in rheumatoid arthritis and may therefore be a useful target for specific immunotherapy. This article summarizes clinical studies using anti-TNF-alpha antibodies. It appears that there is good evidence for both safety and beneficial effects of anti-TNF-alpha antibodies in short-term treatment of rheumatoid arthritis. FUTURE PROSPECTS AND PROJECTS: It remains to be determined whether specific blockade of a single inflammatory mediator may be useful in long-term management. Therapeutic strategies aimed at concomitantly interfering with multiple pathogenic pathways are currently under investigation.

Antibodies, Monoclonal↗
PubMed2000

Fluvastatin decreases soluble thrombomodulin in cardiac transplant recipients.

We conducted a randomized, placebo controlled, double-blind, cross-over study, to assess the effects of a 4-week fluvastatin therapy on plasma markers of endothelial activation or injury in 20 transplanted heart recipients. The levels of thrombomodulin and von Willebrand factor antigen were higher at baseline in cardiac transplant recipients than in age and sex-matched healthy controls. Plasma total cholesterol showed a 21% reduction on fluvastatin therapy (p = 0.0001). Fluvastatin treatment had no significant effect on creatininemia, plasma cyclosporine, PAI-1 antigen, PAI-1 activity, tPA antigen, and Von Willebrand factor. However, fluvastatin produced a significant decrease of plasma thrombomodulin (66.7 ng/ml on placebo versus 58.8 ng/ml on fluvastatin, p <0.001), suggesting a rapid improvement of endothelial injury in these patients.

Aged↗
PubMed1999

[Development of pharmaco-epidemiology in France].

A new scientific discipline: Progress in scientific knowledge, advances in therapeutic innovation, the development of new drugs and the continuing need for optimal drug use impose a new approach to the rational assessment of public health needs and the risks and benefits of therapeutic intervention. In the near future, a new scientific discipline, pharmaceutical epidemiology, will play a leading role. France seems to be a bit behind other western countries in this area. Goal setting: The objectives of industrial firms do not necessarily cover all aspects of the overall goals of society. If the scientific community leaves the development and implementation of pharmaceutical epidemiology in the hands of industrial firms alone, they risk seeing its field of action limited to industrial objectives. The goals of this new discipline must be defined within an unbiased framework aimed at meeting the needs of society in general. Organization: The development of pharmaceutical epidemiology as an integral part of medical research requires a clear definition of its objectives, methods, working hypotheses and time and human allocations. In this context, pharmaceutical epidemiology should be organized within the University and scientific settings currently contributing to scientific research in France (INSERM, CNRS, ORSTOM, etc.). Creating favorable conditions: A pharmaceutical epidemiology network with adequate human and material resources is needed. The wide range of needs expressed by existing institutions (Drug Agency, Prescription and Drug Use Observatory, industrial firms, the national health insurance system, physician and pharmacist associations) pleads for a nationally organized project working in the public domain.

Drug Prescriptions↗