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Biomedical subjects

Patrick Villani

Publications and source records attributed to Patrick Villani.

11 recordsLinked to original sources

Determinants of early identification of suicidal ideation in patients treated with antidepressants or anxiolytics in general practice: a multilevel analysis.

BACKGROUND: General practitioners (GPs) play a key role in identifying and managing patients with suicidal tendencies. Few studies, however, examine both GP and patient characteristics and GP practices associated with suicide assessment. This article aims to evaluate 1) GPs' success in early identification of suicidal ideation (SI) in patients starting antidepressant or anxiolytic treatment, and 2) patient- and GP-related factors associated with this success. METHODS: Survey of 144 GPs practising in southeastern France and of consecutive adults consulting them during June-October 2004 and prescribed antidepressant or anxiolytic treatment. Data were collected from GPs (consultation-questionnaires focusing on their prescription, diagnosis and detection of SI) and patients (self-administered questionnaires including the Hospital Anxiety and Depression scale and social and demographic characteristics). We used multilevel logistic regression to analyse factors associated with SI detection. RESULTS: GPs completed consultation-questionnaires for 713 patients, 405 of whom completed self-administered questionnaires. Eighty-nine patients (22%) reported SI; in 43 cases (48%) SI had not been detected by the GP. GPs detected SI more frequently when they had completed continuing medical education about depression, when patients had higher depressive symptom scores, and when consultations were relatively long. LIMITATIONS: Study limited to patients receiving initial prescriptions for antidepressants or anxiolytics. CONCLUSIONS: The percentage of undetected SI in this study population was high. Additional training of GPs increases the chances of detecting SI. Medical training and continuing medical education should include better instruction about SI risk factors and diagnosis, including non-major depressions, and stress that screening requires sufficient consultation time.

Adolescent↗

Overweight and obesity: knowledge, attitudes, and practices of general practitioners in france.

OBJECTIVE: To describe the current knowledge, attitudes, and practices of French general practitioners (GPs) in the field of adult overweight and obesity management. RESEARCH METHODS AND PROCEDURES: A cross-sectional telephone survey interviewed a sample of 600 GPs, representative of the private GPs in southeastern France. A four-part questionnaire assessed personal and professional characteristics, attitudes and opinions about overweight and obesity, relevant knowledge and training, and practices (diagnostic methods, clinical assessments, weight loss objectives, types of counseling). RESULTS: Most GPs knew that weight problems are health-threatening, and 79% agreed that managing these problems is part of their role. Nevertheless, 58% did not feel they perform this role effectively, and one-third did not find it professionally gratifying. Approximately 30% had negative attitudes toward overweight and obese patients; 57% were pessimistic about patients' ability to lose weight; 64% often set weight loss objectives more demanding than guidelines call for; and neither food diaries nor nutritional education were used systematically. GPs' feelings of effectiveness and attitudes toward obese patients were associated with some professional (training) and personal (BMI, personal diet experience) characteristics. DISCUSSION: GPs' feelings of ineffectiveness may stem from an underlying conflict between practitioners' and patients' representations of weight problems and the relationship problems this causes. Inadequate practices and health care system organization may also play a role.

Attitude of Health Personnel↗

Gefitinib (ZD1839, Iressa) in non-small-cell lung cancer: a review of clinical trials from a daily practice perspective.

Gefitinib (ZD1839) is the most widely studied targeting agent in the area of non-small-cell lung cancer (NSCLC). Gefitinib is an orally active epidermal growth factor receptor (EGFR) tyrosine kinase (TK) inhibitor. In order to assess the role of gefitinib in the management of NSCLC patients, we systematically reviewed published clinical trials from a daily practice perspective. A systematic research was made in the international medical literature. Gefitinib demonstrated a good tolerance and an encouraging efficacy in pretreated NSCLC patients in preclinical studies. These results were then confirmed in two phase II trials (IDEAL 1 and 2) involving more than 400 patients mostly pretreated with a platinum-containing regimen and docetaxel. All these results were reinforced by those of retrospective studies on patients enrolled in a compassionate use programme. Thus, two phase III trials in chemo-naive patients were initiated (INTACT 1 and 2). Unfortunately, the use of gefitinib with standard combination chemotherapy provided no survival benefit nor response rate or progression-free survival improvement over placebo. Furthermore, we also reviewed the results of studies interested in the characterization of predictive clinical or biological markers for response to gefitinib and discussed the results obtained with other EGFR inhibitors. The efficacy of gefitinib in the first-line setting of each stage of NSCLC has to be further studied through clinical trials. Furthermore, translational studies characterizing the molecular features involved in the response to anti-EGFR-targeted therapies are needed.

Adult↗

Gemcitabine-induced severe pulmonary toxicity.

Gemcitabine is a relatively new deoxycytidine analog (2',2'-difluorodeoxycytidine) with structural similarities to cytosine arabinoside (Ara-C). Activity of gemcitabine is demonstrated in the treatment of many solid tumors, like pancreas, ovarian and nonsmall cell lung cancer (NSCLC). Although gemcitabine is considered as a drug with a good safety profile, cases of gemcitabine-induced severe pulmonary toxicity (GISPT) were reported as for Ara-C. We performed a systematic review of reported cases on the GISPT. Twenty-nine clinical trials especially interesting NSCLC patients (21) and 21 reported cases recording 40 patients were analyzed. The incidence of the GISPT varies from 0 to 5%. The clinical presentation is a subacute clinical syndrome and is frequently nonspecific. The predominant radiographic pattern on chest X-ray are reticulo-nodular interstitial infiltrates. It was postulated that the physio-pathological mechanism of the GISPT was an inflammatory reaction of the alveolar capillary wall cytokine-mediated, which created an abnormal permeability of its membrane. After the differential diagnosis were ruled out, the discontinuation of the drug and the early initiation of steroids and diuretics are the most frequently performed treatments. Under these conditions, the outcome was favorable in a delay of few days generally for a majority of patients but 20% of patients died. Some risk factors, as a previous pulmonary disease or a previous thoracic irradiation, for the occurrence of the GISPT were proposed. GISPT is rare but sometimes fatal. Its a necessity to increase awareness about it to enhanced an early and suitable management of patients developing such a toxicity after gemcitabine administration.

Antimetabolites, Antineoplastic↗

Hypnotic and tranquillizer use among general practitioners in south-eastern France and its relation to occupational characteristics and prescribing habits.

Previous research suggests that practising physicians are more likely than the general population to use psychotropic drugs. Hypnotic and tranquillizer use in France is among the highest in Europe; most hypnotic and tranquillizer prescriptions are written by general practitioners (GPs). The objective was to compare the hypnotic and tranquillizer use of GPs in private practice in Provence (south-eastern France) with that of the general population and to study factors associated with physicians' hypnotic and tranquillizer use. A cross-sectional telephone survey was carried out with a panel of 600 GPs in Provence. The data were collected with a 53-item questionnaire about their social and demographic status, family, occupation, training, information-seeking behaviour, job satisfaction, hypnotic and tranquillizer drug use, tranquillizer and antidepressant prescriptions. The data were analysed using univariate and backward multiple logistic regressions. We found that GPs in Provence use hypnotics and tranquillizers at a significantly higher rate than the general population. We found significant associations with hypnotic and tranquillizer use only among the older group of GPs (older than 48 years). In this group, this drug use was related to the volume of services provided (billing sector), job dissatisfaction, lack of training, the 'family burden' and tranquillizer prescriptions. The strains associated with both medical practice and family burden have some influence on hypnotic and tranquillizer use among GPs; individual factors may influence prescribing attitudes and patient care as well.

Adult↗

[Generic drugs in the medical-economic context of drug prescriptions].

REIMBURSABLE DRUGS: The reimbursement, or coverage of pharmaceutical costs by the sickness benefits is governed in the French system by two conditions: the drugs must have been prescribed, and must be listed in the reimbursable drug list. Inscription in the reimbursable drugs list requires approval by the transparency commission, sole commission capable of assessing the medical service rendered (MSR) by the drugs and to propose a reimbursement rate of 65 or 35%. Exceptional drugs and those prescribed in the context of long-term treatments have a specific reimbursement status. ESTABLISHING THE PRICE: The coverage of drugs by the health insurance does not permit free pricing. The costs of drugs are established by the economic committee of health products (Comité Economique des Produits de Santé--CEPS), following approval by the transparency commission, who assesses the improvement in medical services rendered (IMSR) by new products, compared with existing products. THE ECONOMIC ADVANTAGES OF GENERICS: Physicians must be as economical as possible in terms of quality, safety and efficacy of the care they provide. Moreover, to be reimbursed by the social services, a generic must provide improved medical services or lead to savings in the cost of treatment. In such conditions one can conceive that the price of a generic (which does not provide any improvement in medical services compared with the original drug) is legitimately cheaper than the original product, and source of economy for better allocation of available funds. TWO MOTIVATING MEASURES: However, the French generic market is one of the least developed among industrialized countries. Presently, the volume of generics only represents 5% of the French drug market. Its further development is foreseen within the framework of all the plans for medicalized control of health costs. Other than the classical motives that encourage prescription of generics, i.e., citizens' awareness, labelling and the control by the French medicines agency, new determinating measures in our right for health are: the pharmacists' right to substitute and the physicians' authorization and incitement then to prescribe a product under its international non-proprietary name.

Costs and Cost Analysis↗

[Critical review of the publication of a clinical trial].

THE MAIN OBJECTIVES OF THE CRITICAL REVIEW OF THE PUBLICATION OF A CLINICAL TRIAL: Are to underline the biases that may influence the validity and credibility of the results and to assess the quantity of the effect observed and the potential clinical impact. FOUR PRELIMINARY ELEMENTS: Should be taken into account: publication in a journal with a reading committee, notoriousness of the author, the interest declared by the authors and the approval of an ethics committee. EXAMINATION OF THE REPORT ITSELF: Concerns the study objectives, clearly defined and integrated within the logics of a scientific context and suggesting concrete applications. A good quality demonstrative trial is prospective, controlled, randomized, and carried out double blind. The patients included are clearly characterized in order to know to what type of patient the research results can subsequently be applied. The principle end-point, whenever possible, is of clinical significance. The choice of the comparative arm is pertinent. The required number of patients has been calculated. The author has agreed to respect Good Clinical Practice and the statistical analyses are appropriate. THE RESULTS: Presented clearly, must indicate the patients in whom the values observed have been calculated. The confidence intervals are provided. The principle analysis, in intent to treat, includes the principle end-point. The significance threshold is 5%. The extent of the difference between the results of the groups is detailed and of clinical significance. Any causal imputation is documented. The results of eventual sub-group analyses are only provided for information. THE DISCUSSION: Concerns the scope of the results, their internal and external coherence with already validated data. The conclusion, factual, evokes the eventual therapeutic benefits of the research conducted. With regard to the latter, readers will be interested in the application of the results obtained to their own patients.

Advisory Committees↗

[The statins: new properties]].

The comparison of major statin trials with trials using either cholestyramine or ileal bypass has suggested that the reduction in coronary heart disease events for those patients receiving statin therapy largely result from their low density lipoprotein (LDL)-cholesterol lowering action. LDL-cholesterol lowering has several physiological consequences, including plaque stabilisation with a decrease in the inflammatory process, slowing of plaque progression, and improvement of endothelial function, as evidenced by the measurement of endothelial-dependent vasorelaxation in response to hyperhaemia or acetylcholine infusion. Statins lower C-reactive protein without any consistent effect on the other inflammation acute phase proteins. The cause and consequences of this effect are still debated. In order to explain why some statins can prevent coronary events within a few months, a direct effect of this therapy on thrombosis has also been advocated; however, the evaluation of statin antithrombotic effects in humans has produced conflicting results. By inhibiting L-mevalonic acid synthesis, statins also prevent the farnelysation of small-GTP binding proteins such as Rho and Ras. In vitro, and in animal models, the inhibition of Rho with statins results in a decrease in endothelial nitric oxide production, an inhibition of leucocyte adhesion on endothelium, decrease in PPAR alpha activation and high density lipoprotein (HDL) production by the hepatocyte, decrease in Ca2+ stores in vascular smooth cells, and a stimulation of vascular smooth muscle cell apoptosis. However, most of these effects were obtained with high statin concentrations. Further evidence is needed before a full assessment of the clinical importance of isoprenylation blockage with therapeutic concentrations of statins in humans can be made.

Animals↗

[Do premarketing trials help to predict drug-related iatrogenic effects in elderly patients?].

Premarketing trials contribute poorly to predicting drug-related iatrogenic effects in elderly patients. Since their main goal is the demonstration of drug efficacy, these trials are characterised by a simplistic design, they include a limited number of young participants (volunteers only), are of a short duration, and follow a strict protocol. Results of studies in young people cannot be extrapolated to elderly people. Although licensing authorities recommend the recruitment of a meaningful number of elderly people in clinical trials (with an age distribution comparable to that expected when the drug is in routine use), even in trials that are not devoted to geriatric illnesses, elderly people remain substantially under-represented in most instances for methodological reasons (to avoid increased variance introduced by a heterogenous population), safety reasons (at this stage of drug development, it could be deleterious to include patients with comorbid conditions and unfair with regard to the brand image of the products), and ethical reasons (the decision to participate could not be taken by the elderly people alone). Exclusion of elderly participants, who are particularly exposed to drug-related iatrogenic effects, influences the generalisability of study findings. The recruitment of elderly participants, a vulnerable population, is necessary to allow valid conclusions regarding elderly people, recommendations on the appropriate dosage adjustment for elderly individuals, the avoidance of prescribing decisions based on inadequate information (with respect to a more informative summary of the characteristics of the products), and the maximum benefit for elderly people from research.

Aged↗