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Biomedical subjects

M Vray

Publications and source records attributed to M Vray.

18 recordsLinked to original sources
PubMed2004

Assessment of migraine severity using the MIGSEV scale: relationship to migraine features and quality of life.

We have recently developed an instrument to describe and categorize severity of migraine attacks from patient self-report, the MIGSEV questionnaire. We have now performed a large prospective survey using this tool to evaluate migraine severity in 2979 patients consulting for headache in France, included by 1164 general practitioners, 174 neurologists and 82 gynaecologists. The objective of the study was to determine the prevalence of severity grades in a large population who consults for migraine, to test the concordance between severity calculated from physician-derived and patient-derived data, and to test the relevance of the concept of severity as applied to diagnosis, other measures of the burden of migraine, and to health-related quality of life. Severe attacks were reported in around one-fifth of the sample. Physician- and patient-derived data provided concordant estimates of severity in 71% of cases, the discordant cases representing principally an underestimate by the physician of headache severity. Migraine severity was associated with frequent, long-lasting and treatment-resistant attacks, and with poor quality of life. The MIGSEV questionnaire is proposed as a simple measure of severity for the diagnosis and management of migraineurs, suitable for use both by physicians and patients.

Adolescent↗
PubMed2001

Heart rate-lowering and -regulating effects of once-daily sustained-release diltiazem.

BACKGROUND: Epidemiologic evidence suggests that an elevated heart rate (HR) is an adverse and independent prognostic factor in arterial hypertension and other cardiovascular diseases. Although diltiazem is characterized as an HR-lowering calcium antagonist, no studies have quantified the magnitude of HR changes in patients with angina or hypertension. HYPOTHESIS: The study was undertaken to explore the magnitude of proportional HR reduction at varying levels of resting HR with the sustained-release formulation of diltiazem (SR diltiazem) at the usual clinical doses of 200 or 300 mg once daily. METHODS: This meta-analysis was conducted on six comparative double-blind studies including 771 patients with angina or hypertension in which SR diltiazem 200-300 mg once daily was compared either with placebo or with other agents known not to influence HR (angiotensin-converting enzyme inhibitors, diuretics). Sustained-release diltiazem decreases elevated baseline HR, with an increasing effect at higher initial rates. RESULTS: Multiple comparisons by baseline HR category showed a significant difference between both groups for baseline HR of 74-84 beats/min and > or = 85 beats/min (p = 0.001). Sustained-release diltiazem had no significant HR-decreasing effect on baseline HR < or =74 beats/min but appears to have a genuine regulating effect on HR: it reduces tachycardia without inducing excessive bradycardia. These findings are in contrast to those with dihydropyridine calcium antagonists, which tend to increase HR and have been associated with an adverse outcome in acute cardiovascular conditions. At the same time, there is evidence to suggest that HR-lowering calcium-channel blockers decrease cardiovascular event rates following myocardial infarction. CONCLUSION: When calcium antagonists are indicated for use in patients with angina or hypertension, an HR-lowering agent, that is, diltiazem rather than dihydropyridine, should be recommended.

Angina Pectoris↗
PubMed2000

Macronutrient energy intake and adiposity in non obese prepubertal children aged 5-11 y (the Fleurbaix Laventie Ville Santé Study).

OBJECTIVE: To investigate associations between adiposity indices and food intake in nonobese prepubertal free-living children. SUBJECTS: Five-hundred and one children, 280 boys and 221 girls aged 5-11 y in two little towns in northern France. DESIGN: Cross-sectional survey. MAIN OUTCOME MEASURES: Height and weight, four skinfolds (biceps, triceps, subscapular, suprailiac), waist and hip girths, were measured. Sum of skinfolds (SSF), body mass index (BMI), and relative weight (RW) were calculated. Energy intake (EI), percentage of energy intake ascribed to carbohydrates (%EIC), complex carbohydrates (%EICC), fats (%EIF), saturated fats (%EISF) and proteins (%EIP) were assessed by a single 24 h record. Basal metabolic rate (BMRI was estimated according to Schofield's equations. Obese (RW > or = 120%), and underreporting children according to Goldberg's and Black's equations were excluded. RESULTS: In multiple linear regressions analyses performed with hierarchical mixed models, adiposity indices were significantly and inversely associated in girls with %EIC (all P-values < 0.02), and positively with %EIF (all P-values < 0.05, waist girth and BMI excepted). Similar but non-significant trends were observed in boys. The relationships were not linear, and thresholds close to current dietary recommendations were highlighted. When %EIF was low, a lower percentage of energy intake ascribed to %EISF was associated with thinness. These associations remained after the exclusion of children who had an EI/BMR > or = 1.50. CONCLUSIONS: In nonobese prepubertal children aged 5-11 y, a high %EIC, close to dietary recommendations (> or = 55%), was associated with thinness. A high %EIF, over the upper dietary recommendation (< or = 35%), was associated with a greater adiposity thickness. There was no further increase in adiposity beyond this threshold. Reasons for the absence of a linear relationship pattern between adiposity and macronutrient intake remain to be determined.

Adipose Tissue↗
PubMed1998

Food and nutritional data for a population from northern France: the Fleurbaix Laventie Ville Santé (FLVS) Study.

BACKGROUND: This paper describes nutritional characteristics and eating habits of the participants of the Fleurbaix Laventie Ville Santé study. METHODS: One-day dietary records for children (under 14 years of age) and three-day records for adolescents and adults provided nutritional data for 2,364 people between the ages of 2 and 70. RESULTS: Daily energy intake increased up to the age of 18 (9038 +/- 2620 kJ in women and 11,659 +/- 2146 kJ in men) and decreased thereafter. In parallel, the contribution of fat and protein to energy intake increased with age (respectively 42% and 18% in people older than 40) whereas the contribution of carbohydrates decreased (40% in people older than 40). The daily distribution of energy intake indicated increased contributions of lunch and dinner with age, and decreased contributions of breakfast and of afternoon snacks. Consumption of potatoes and processed meat far exceeded that of fruit, bread and fish. In comparison to recommended intakes and to other French nutritional studies, total energy intake in our study was similar, whatever the sex and age range. In contrast, the contribution of fat and protein to energy intake was always higher while that of carbohydrates was lower. This was especially true for the adults. CONCLUSIONS: These differences cannot be entirely explained by the differences in methodologies used and are undoubtedly due to the regional eating habits in the area studied.

Adolescent↗
PubMed1997

Determinants and nature of dietary underreporting in a free-living population: the Fleurbaix Laventie Ville Santé (FLVS) Study.

OBJECTIVE: To study the determinants and nature of dietary underreporting in a free-living population. DESIGN: Cross-sectional study of nutritional and behavioural characteristics. SUBJECTS: 1030 weight-stable subjects, 501 women and 529 men older than 15 y, included in the Fleurbaix Laventie Ville Santé study. MEASUREMENTS: Dietary intake was assessed using a 3 dy dietary record. Self assessed body weight and height were also recorded. Behavioural and socio-economic data were obtained from a questionnaire. Underreporters were defined as people with a reported ratio of energy intake to estimated basal metabolic rate lower than 1.05. RESULTS: Underreporting concerned 16% of the population and was significantly more frequent in obese than in non obese subjects (P < 0.001). Underreporting was significantly associated with a high socio-professional class (P < 0.05), having dieted at least once (P < 0.01) and to be in dietary restraint (P < 0.05). Furthermore, the contribution of protein to energy intake was significantly higher in underreporters than in non underreporters, independently of weight status. CONCLUSIONS: These data underline that underreporting may bias the assessment of energy and macronutrient intake, particularly in studies on obesity and dietary restraint. Questions about weight concern, dieting and dietary restraint may be useful to identify subjects who underestimate their food intake.

Adolescent↗
PubMed1995

National study of obliterative arterial disease of the lower limbs involving general practitioners in France: Artemio study.

A national survey was performed in France from May to June, 1993. The aim of this study was to evaluate general practitioners' attitudes and behaviors when diagnosing and managing patients with lower extremity arterial disease (LEAD). One thousand general practitioners, randomly drawn from an exhaustive list, were contacted to participate in a telephone interview concerning the last patient with intermittent claudication seen in their practice. Four hundred seventy-six general practitioners participated. Risk factors noted for these 476 patients with intermittent claudication were in agreement with the literature: 86% were men aged 64 +/- 10 years (mean +/- SD) and 14% were women aged 73 +/- 8 years. Sixty-two percent had a pain-free walking distance of between 100 and 500 meters at diagnosis. Forty-five percent were former smokers and 37% currently smoked; 55% had hypertension, 14% diabetes, and 56% disturbances of lipid metabolism. A majority of them were hypercholesterolemic. The diagnosis of the disease was based primarily on a clinical assessment, confirmed for 33% by Doppler or echo Doppler. The mean duration of diagnosis was 4.4 +/- 4.1 years. Management of the disease was mainly by prescription of vasodilators (91%), antiplatelet agents (59%), and anticoagulants (8%). Use of Doppler or echo Doppler was recommended once a year. Infection was observed in 27% of patients. Thirty-eight percent had had a cardiac incident (angina pectoris or myocardial infarction) and 10% a cerebrovascular accident. They differed significantly from those with LEAD alone for the following parameters: age (68.5 +/- 9.2 vs. 63.2 +/- 10.3 years; p < 0.001); duration of LEAD (5.6 +/- 4.6 vs. 3.6 +/- 3.5 years; p < 0.001); hypertension (65% vs. 50%; p < 0.01); and current smoking (29% vs. 43%; p < 0.01). This survey confirmed the feasibility of telephone interviewing, on a large sample of general practitioners in France. The high level of association with other cardiac incidents was, for these patients, a much higher risk of mortality and morbidity than LEAD alone. It would be interesting to validate the associations observed with a prospective study of comorbidity.

Adult↗
PubMed1995

Randomized study of glibenclamide versus traditional Chinese treatment in type 2 diabetic patients. Chinese-French Scientific Committee for the Study of Diabetes.

The purpose of this study was to evaluate the efficacy of a traditional Chinese treatment (TCT) based on three plants in association with a sulfonylurea, glibenclamide (2.5 mg X 3/d). A 2 X 2 factorial design was adopted for this multicentre randomized double-blind trial involving 4 groups [A = placebo (P) TCT + P glibenclamide; B = P TCT + verum glibenclamide; C = verum TCT + P glibenclamide; D = verum TCT + verum glibenclamide]. Patients included were type 2 diabetic outpatients, 40-70 years of age, treated by diet alone or oral anti-diabetic drugs. Endpoint criteria evaluated were HbA1, blood glucose and plasma insulin (at fasting, and 1 and 2 h after a test meal). At each visit, a clinical examination was performed, and a questionnaire on side effects and associated symptoms was completed. The dose was reduced by half in the case of hypoglycaemia. The 216 patients were recruited in 5 centres [Shanghai (1) = 48, Shanghai (2) = 40, Beijing = 40, Canton = 42, Chengdu = 46 and randomized into treatment groups A, B, C, D (56, 56, 50 and 54 respectively). Eleven patients were withdrawn for administrative reasons. In patients treated with glibenclamide, a significant increase in weight and insulinaemia was observed, together with a significant decrease in blood glucose values; in those receiving TCT, blood glucose values were significantly decreased only 2 h after the test meal. A synergistic effect on blood glucose was observed when both treatments were given. Hypoglycaemia occurred in 19 patients (all in the two verum glibenclamide groups). This first multicentre controlled trial showed that the 3 Chinese plants tested were well-tolerated and effective in Type 2 diabetes as indicated by a significant synergistic effect in association with a sulfonylurea.

Adult↗
PubMed1994

Epidemiology of peripheral arterial disease.

With the aging of the population of most developing nations, arteriosclerosis is becoming a major health problem. Although much research has concentrated on the coronary and cerebral forms of the disease, peripheral arterial disease has received little attention from epidemiologists. The "Rose questionnaire" has been used extensively to diagnose intermittent claudication; however, the current method of choice for the diagnosis of peripheral arterial disease in epidemiologic studies is the ankle brachial pressure index. The prevalence of intermittent claudication, diagnosed by the Rose questionnaire, differs according to age, sex, and geographical location varying between 0.4 and 14.4%; similar variability (from 4.2 to 35%) is seen for disease diagnosed by the ankle brachial pressure index. The major risk factor for peripheral arterial disease is cigarette smoking; hypertension and diabetes have been identified as risk factors in a number of studies; impaired glucose metabolism, dislipidemia, degree of physical activity, and coagulation factors have been identified in some populations. The coexistence of cardiocerebrovascular and peripheral vascular diseases enhances the risk of early death, which is more than double that in the general population: The most frequent cause of death is myocardial infarction. More work is required to document the natural history of the disease, the risk factors for its progression, its relationship with cardiovascular disease, and the effect of intervention strategies.

Age Factors↗
PubMed1989

Rioprostil and ranitidine in the prevention of duodenal ulcer relapse.

One hundred and ninety duodenal ulcer patients who had relief of pain and endoscopically proven ulcer healing after a short treatment period are allocated at random to double-blind maintenance treatment with a synthetic dehydroprostaglandin-E1, rioprostil, 300 micrograms, or ranitidine, 150 mg, at bedtime for 6 months. Patients are monitored every two months and examined by endoscopy after six months of treatment, or more often if warranted. The cumulative relapse rate in the rioprostil group at six months is 32% (25/78) vs. 28% (20/72) in the ranitidine group. This difference is not significant. The percentage of side effects observed is 17% in the rioprostil group vs. 5% in the ranitidine group, but discontinuation of treatment is observed with the same frequency in the two groups.

Anti-Ulcer Agents↗
PubMed1989

Rioprostil vs. ranitidine in duodenal ulcer healing: a double-blind multicentre trial.

A total of 156 patients with endoscopically proven duodenal ulcers are randomized in a double-blind, multicentre trial comparing rioprostil, 300 micrograms b.d., with ranitidine, 150 mg b.d. With rioprostil, the cumulative healing rate by endoscopy is 73% at 4 weeks, and 87% at 6 weeks. With ranitidine it is 79% and 92%, respectively. There is no difference in the occurrence of pain after the two types of treatment, and the side effects are comparable in the two groups. These results show that rioprostil is probably as effective and safe as ranitidine in the treatment of duodenal ulcer.

Adult↗
PubMedDate not supplied

Modelling in economic evaluation: an unavoidable fact of life.

The role of modelling in economic evaluation is explored by discussing, with examples, the uses of models. The expanded use of pragmatic clinical trials as an alternative to models is discussed. Some suggestions for good modelling practice are made.

Clinical Trials as Topic↗
PubMedDate not supplied

[Pharmaco-epidemiology: identification of needs, databases, and study quality criteria].

Reference data on pathologies, their management, risk factors and the use of drugs in real life is necessary. In France, there are no existing databases of a set of systematically recorded data which associate information on drugs and morbidity/mortality. In contrast, there are a great number of studies focused on pathologies, their management or on drugs. A directory that could identify these databases and a means of accessing them would be desirable. Pharmaco-epidemiology studies must answer epidemiologically specific quality criteria, which must be planned at study conception. The protocol must be developed with a scientific committee on which there are epidemiologically experienced people. It is a prerequisite that a committee of experts with epidemiological competence should give advice on the 'acceptability' of the protocol, that is on the aim and the methodology. Data collection must be the subject of specific quality control of both the study and its aims. Cross-checking with other sources of data is recommended when possible. The coordinator of each study must send a final report to investigators and publish the results.

Clinical Protocols↗
PubMedDate not supplied

[Clinical evaluation: from intermediate to surrogate criteria].

The development and evaluation of new drugs often rely on surrogacy. An intermediate outcome becomes a surrogate outcome if it fulfils certain criteria, it should be easier to measure compared with the clinical outcome, a statistical relationship should exist between the clinical outcome and the surrogate outcome, a relation should exist allowing prediction of the degree of clinical effect based on the measured effect on the surrogate outcome. Development and authorization of drugs today often rely on so-called surrogate outcomes. Is this use sound? The validity of such outcomes has been reviewed in different therapeutic areas: hypertension, venous thromboembolism, AIDS, osteoporosis, hepatitis C. Based on this review, a pragmatic strategy is proposed which allows for the validation and proper use of surrogate outcomes.

Acquired Immunodeficiency Syndrome↗