PubMed Health⌕ Search

Biomedical subjects

M Lièvre

Publications and source records attributed to M Lièvre.

At least 19 recordsLinked to original sources
PubMed2006

[Flecainide acetate utilisation review among general practitioners and hospital or office-based cardiologists in France. Obepine: observational study of flecainide].

A pharmacoepidemiological cross-sectional observational study was performed among a representative sample of French general practitioners and cardiologists. The aim of this study was to describe the prescription modalities of flecainide acetate, an Ic class antiarrhythmic, and how these modalities match the marketing authorization and the current summary of product characteristics. A total of 941 physicians participated in the study, 496 GPs and 445 cardiologists, and 1116 patients treated with flecainide for more than one month were included. On average, the patients were 68.7-years-old and 54% of them were women. Most of the initial flecainide prescriptions came from cardiologists (96%) and the check-up included an electrocardiogram (98%), a Holter monitoring (56%) and/or an echocardiography (71%). The preferred indication was supraventricular rhythm disorders (95%) and mostly atrial fibrillation (63%). A small proportion of coronary patients (7%) and of patient suffering from cardiac insufficiency (4%) was found. Flecainide was prescribed with a median posology of 150 mg per day, mostly as LP form (64%). Overall, the indications specified in the summary of product characteristics were respected in 90% of the cases, the contraindications in 91% of the cases and the patient follow-up was appropriate in 99% of the cases. In conclusion, the study showed that the prescription's conditions of flecainide in France complied with the summary of product characteristics data for most of the prescribing physicians with a respect of the indications, contraindications and management recommendations in 84% of the cases.

Aged↗
PubMed2005

Cross-sectional study of care, socio-economic status and complications in young French patients with type 1 diabetes mellitus.

OBJECTIVES: To describe the present status of type 1 diabetes care in France and study the relations between clinical and socio-economic variables on one hand and disease management and prevalence of complications on the other hand. METHODS: A random sample of 365 French specialists in diabetes care performed a cross-sectional study and included consecutively 562 children aged 10-16 and 1691 adults aged 16-45, with more than 2 years of type 1 diabetes. The main outcome measures were the prevalence of complications (retinal, renal, lower-limb, cardiovascular, ketoacidosis); disease management parameters (blood pressure, HbA1c, daily number of insulin injections, frequency of visits to a specialist in diabetes, membership of a patient association); socio-economic status as a score, and treatments received. RESULTS: Retinal complications were rare in children (0.7%) and common in adults (28.3%). 10.2% children and 15.2% adults had micro- or macro-albuminuria, 4.7% adults had plasma creatinine >or=150 micromol/L. Only 15% children and 26% adults had HbA1c<7%, 86.2% children and 62.7% adults had blood pressure<130/85 mmHg; 58% children and 80% adults had at least 3 daily insulin injections. In adults, the risk of experiencing at least one complication was linked significantly with diabetes duration, HbA1c, and socio-economic status. Age, sex, type of insulin therapy, tobacco consumption, and blood pressure control were not significant parameters. Ketoacidosis in the preceding year was only linked with HbA1C and socio-economic status. CONCLUSION: Although this sample of patients had overall a fair socio-economic status and were followed-up by specialists of diabetes care, metabolic and blood pressure control were not optimal. The care of French type 1 diabetics could probably be improved by a stricter control of glycaemia and blood pressure, and an earlier use of intensive insulin treatment, with a particular focus on adolescents and patients with the lowest socio-economic status.

Adolescent↗
PubMed2004

Preconditioning during coronary angioplasty: no influence of collateral perfusion or the size of the area at risk.

AIMS: It is unclear whether the protection observed in human heart following repetition of brief episodes of ischaemia is due to opening of coronary collaterals or to ischaemic preconditioning. We investigated whether the improvement in ST segment change following repeated episodes of brief ischaemia during coronary angioplasty is due to preconditioning when the size of the area at risk and the collateral flow are taken into account. METHODS AND RESULTS: Thirty-six patients underwent percutaneous transluminal coronary angioplasty. Intracoronary ST segment changes were measured throughout the procedure and used as an endpoint. The size of the area at risk and the collateral perfusion within the ischaemic bed were measured using single photon emission computerized tomography (SPECT). Mean ST segment shift observed in all patients significantly decreased from 11.0+/-2.6 mm during the first balloon inflation to 8.5+/-2.3 mm during the second inflation. This protective effect occurred in the absence of any change in the size of the area at risk (mean: 46+/-5% of LV) and of the collateral perfusion to the ischaemic zone (mean: 23+/-4% of flow in the non-ischaemic zone). CONCLUSION: These results suggest that ischaemic preconditioning does occur during repeated brief coronary artery occlusion in the human heart.

Adolescent↗
PubMed2001

[Type 2 diabetes and cardiovascular risk: lessons from therapeutic trials].

Cardiovascular risk reduction in diabetic patients is a multidimensional task. Long-term decrease of glycaemia by the use of insulin or sulfonylureas had disappointing effects on cardiovascular events, whereas metformin effects are ambiguous. On the contrary, controlling risk factors like hypertension or hypercholesterolaemia decrease the incidence of cardiovascular events in diabetic as in non-diabetic patients. Similarly, clinical trials have shown the efficacy of treatments that decrease cardiovascular risk whatever the cause, such as antiplatelet drugs in secondary prevention and high-dose ramipril in secondary prevention or in hypertensive patients. The absolute benefit conferred by efficient therapies is higher in diabetic patients because they are at an increased risk of events compared with their non-diabetic counterparts.

Angiotensin-Converting Enzyme Inhibitors↗
PubMed2000

Oral Beraprost sodium, a prostaglandin I(2) analogue, for intermittent claudication: a double-blind, randomized, multicenter controlled trial. Beraprost et Claudication Intermittente (BERCI) Research Group.

BACKGROUND: Beraprost sodium (BPS) is a new stable, orally active prostaglandin I(2) analogue with antiplatelet and vasodilating properties. We report the results of a phase III clinical trial of BPS in patients with intermittent claudication. METHODS AND RESULTS: Patients (n=549) with a pain-free walking distance of between 50 and 300 m were entered into a 4-week single-blind placebo run-in phase. Patients whose pain-free walking distance had changed by <25% were then randomized to receive either BPS (40 microg TID, n=209) or placebo (n=213) in a double-blind manner for 6 months. Pain-free and maximum walking distances were measured on the occasion of treadmill exercise tests performed at baseline and 1.5, 3, 4.5, and 6 months after randomization. Success was defined as an improvement of >50% in pain-free walking distance at month 6 and in > or =1 earlier treadmill exercise test in the absence of critical cardiovascular events. Success was observed more frequently in the BPS group (43.5%) than in the placebo group (33.3%, P=0.036). Pain-free walking distances increased by 81.5% and 52.5%, respectively, in the BPS and placebo groups (P=0.001) and maximum walking distances by 60.1% and 35.0%, respectively (P=0.004). The incidence of critical cardiovascular events was 4.8% in the BPS group and 8.9% in the placebo group. CONCLUSIONS: These results show that BPS is an effective symptomatic treatment of patients with intermittent claudication. The beneficial effects of BPS on critical cardiovascular events should be confirmed in appropriate clinical trials.

Administration, Oral↗
PubMed2000

[Clinical benefits of cholesterol lowering treatments. Meta-analysis of randomized therapeutic trials].

PRIMARY PREVENTION: A meta-analysis of the 7 available randomized cholesterol lowering trials (2 on statins, 2 on fibrates, 2 on resins and 1 on diet) demonstrates a significant 24% relative reduction in the frequency of fatal and non-fatal coronary events, leading to a significant 14% relative reduction in coronary disease related mortality. For total mortality, the statin trials were not comparable with other treatments where there was a trend to overmortality. With the 2 statin trials, there was a nonsignificant 13% reduction in total mortality. SECONDARY PREVENTION: A meta-analysis of the 13 available randomized trials (3 with clofribrate, 1 with gemfibrozil, 2 with nicotinic acid, and 4 with diet) showed a significant 21% reduction in the frequency of fatal and non-fatal coronary events, coronary mortality and total mortality. For total mortality, only the result of the 2 statin trials was significant (-20%). BENEFICIAL EFFECT OF STATINS, ABSOLUTE VALUES: Measured as the number of patients to treat for 5 years in order to avoid 1 event (NNT), there is a clinically pertinent benefit of secondary prevention (NNT = 15 for events, NNT = 30 for coronary mortality). The absolute value is weaker when patients with minimally elevated cholesterol levels are included. For primary prevention, the absolute value is low with NNT = 44 for events and NNT = 300 for coronary mortality. In addition, as these results were obtained in trials including populations with a much higher risk than the general French population, the absolute beneficial effect may not be pertinent in France except in high-risk patients who present, in addition to a high cholesterol level, other cardiovascular risk factors.

Anticholesteremic Agents↗
PubMed2000

The non-insulin-dependent diabetes, hypertension, microalbuminuria or proteinuria, cardiovascular events, and ramipril (DIABHYCAR) study: design, organization, and patient recruitment. DIABHYCAR Study Group.

The non-insulin-dependent DIABetes, HYpertension, microalbuminuria or proteinuria, CARdiovascular events, and Ramipril (DIABHYCAR) study is a randomized, prospective, double-blind, placebo-controlled, multicenter international trial of the ACE inhibitor ramipril (1.25 mg/day) in patients with type II diabetes and micro- or macroalbuminuria. The main outcome of the study is the time to first occurrence of either death from a cardiovascular origin, including sudden death, nonfatal myocardial infarction, stroke, or congestive heart failure, or requirement of hemodialysis or renal transplantation. The study was launched in France in early 1995 with the participation of general practitioners only, but had to be extended to 15 other countries in 1997 due to difficulties in recruitment. Since 2.5 years after the beginning of the trial the observed event rate was much less than anticipated, it was decided to increase recruitment and follow-up duration and to include congestive heart failure in the definition of the main outcome to keep the study power at a satisfactory level. Recruitment ended on April 1, 1998 with 4937 randomized patients. Following the early discontinuation for efficacy of another study of ramipril in high cardiovascular risk patients, the Heart Outcomes Prevention Evaluation study (HOPE), the second interim analysis of DIABHYCAR was performed early (when 406 instead of 500 patients presented a main outcome) and the Data Safety and Monitoring Board recommended that the study continue. Follow-up is planned to end on March 31, 2001.

Aged↗
PubMed2000

Determinants of elevated urinary albumin in the 4,937 type 2 diabetic subjects recruited for the DIABHYCAR Study in Western Europe and North Africa.

OBJECTIVE: Whether ACE inhibition is useful for type 2 diabetic patients with micro- and macroalbuminuria remains unknown. The Non-Insulin-Dependent Diabetes, Hypertension, Microalbuminuria, Cardiovascular Events and Ramipril (DIABHYCAR) Study was set up to address this issue through a multicenter double-blind parallel placebo-controlled > or = 3-year trial in Europe and North Africa. In this article, we report the characteristics of the randomized patients. RESEARCH DESIGN AND METHODS: The main selection criteria were as follows: men or women aged > or = 50 years with type 2 diabetes treated with oral antidiabetic drugs, with or without hypertension, with a plasma creatinine level < 150 mumol/l, and with persistent micro- or macroalbuminuria, as assessed centrally by two successive urine samples containing a urinary albumin concentration > or = 20 mg/l. Patient characteristics were studied by comparing patients who were randomized to those who were not, taking their geographical origin into account. RESULTS: There were 25,455 patients screened for urinary albumin (20,296 from France, 918 from Germany, 1,019 from Northwest Europe, 969 from Central Europe, 959 from Mediterranean Europe, and 1,294 from North Africa). Of these patients, 4,937 were randomized. Compared with the nonrandomized patients, the randomized patients were older, more often men, more obese, had higher systolic/diastolic blood pressure and plasma glucose, smoked more tobacco, drank more alcohol, and had complications more frequently. Using a logistic regression analysis, all the above-mentioned items appeared as independent determinants for randomization into the study, with the exception of alcohol intake. The contribution of each item varied slightly from one geographical origin to another. CONCLUSIONS: The physical, biological, and behavioral characteristics create a poor renal and cardiovascular prognosis for the type 2 diabetic patients randomized to the DIABHYCAR Study because of micro- and macroalbuminuria. Testing the usefulness of ACE inhibition for the type 2 diabetic patients with microalbuminuria seems feasible through the DIABHYCAR Study.

Africa, Northern↗
PubMed2000

Efficacy of diuretics and beta-blockers in diabetic hypertensive patients. Results from a meta-analysis. The INDANA Steering Committee.

OBJECTIVE: To review the effectiveness of diuretic or beta-blocker-based treatment of hypertension in diabetic patients. RESEARCH DESIGN AND METHODS: A meta-analysis on individual patient data was performed on four trials of the treatment of hypertension in which diabetic patients were included and treated with first-line diuretics or beta-blockers. The main outcomes were the relative risk of death, fatal or nonfatal stroke, fatal or nonfatal coronary events, and major cardiovascular events. RESULTS: There were 92 diabetic patients who received first-line beta-blockers and 1,008 who received diuretics. In the control groups, diabetic patients had nearly twice the risk of any outcome when compared with nondiabetic patients. The same blood pressure reduction was achieved under treatment in the diabetic and nondiabetic patients, except for systolic pressure, which decreased more in the nondiabetic patients at 1 year. In the 15,843 nondiabetic patients, the risk of all four outcomes was reduced significantly in the treated group. In the 2,254 diabetic patients, the risk reduction was significant only for fatal and nonfatal stroke (36%, P = 0.011) and major cardiovascular events (20%, P = 0.032), but not for death (5%, P = 0.65) and fatal or nonfatal coronary events (15%, P = 0.23). However, no heterogeneity was detected between diabetic patients and nondiabetic patients for any outcome. The numbers of outcomes avoided for 1,000 patients treated for 5 years were higher in diabetic patients (e.g., 38 major cardiovascular events) than with nondiabetic patients (e.g., 28 major cardiovascular events). CONCLUSIONS: These results show that hypertensive diabetic patients benefit from first-line treatment with diuretics. No conclusion can be drawn for beta-blockers, owing to the small sample size.

Adrenergic beta-Antagonists↗
PubMed1997

Outcome of atrial fibrillation after mitral valve repair.

OBJECTIVE: The aim of the study was to evaluate the prognostic factors for return to sinus rhythm after mitral valve repair. METHOD: One hundred ninety-one patients underwent surgery for mitral valve repair, including 142 procedures for valve repair only (74%). The patients with preoperative atrial fibrillation (50.5%) were older, clinically more symptomatic, and had a greater degree of left atrial dilation than the patients who had sinus rhythm. RESULTS: Preoperative cardiac rhythm, the duration of preoperative atrial fibrillation, and a lesser degree of left atrial hypertrophy are significant prognostic factors independent of the maintenance of sinus rhythm. The probability of return to stable sinus rhythm was 93.7% when sinus rhythm was already present before the operation and 80% when atrial fibrillation was intermittent or of less than 1 year's duration; probability declined abruptly for durations over 1 year. No significant difference in patient survival was noted between those who had sinus rhythm (99% +/- 0.9% at 1 year and 86% +/- 6.6% at 5 years) and those who had atrial fibrillation in the preoperative period (95% +/- 3.1% at 1 year and 86% +/- 8.4% at 5 years). In contrast, the postoperative return to sinus rhythm was associated with 99% +/- 0.9% and 94% +/- 4.8% survivals at 1 and 4 years versus 97% +/- 1.5% and 77% +/- 13% in the event of postoperative atrial fibrillation. CONCLUSION: The aim of restoring postoperative sinus rhythm after mitral valve repair should lead to surgery being conducted on patients who have sinus rhythm or recent-onset atrial fibrillation. Surgery for atrial fibrillation may be of value in patients with a long history of atrial fibrillation, providing that it does not induce prohibitive excess mortality.

Adult↗
PubMed1997

Validation of a new quantitative coronary angiography analysis system used to evaluate densitometric lumen remodelling.

Arterial lumen volume, determined by sequential coronary angiography, could have advantages over more commonly used variables (such as percent stenosis or minimal lumen diameter) as a primary endpoint in clinical trials evaluating post-angioplasty restenosis or atherosclerotic plaque progression. We validated a quantitative coronary angiography analysis (QCA) system aimed at measuring lumen volume from coronary angiography films by a densitometric method. Using images of polyacrylate models filled with different concentrations of contrast medium, accuracy (mean of the differences between known and measured values of a measurement) and precision (standard deviation of the difference) were lower than or equal to 0.09 and 0.21 mm, respectively, for diameters ranging from 1.5 to 16 mm. In terms of volume measurement, accuracy was 30.2 mm3 and precision 5.7 mm3 for a known volume of 620.2 mm3. To assess the short-term variations of lumen volume measurements under conditions resembling those encountered in clinical trials, a special image comparison program of the QCA system was used to measure the same coronary artery segment on two images taken 10 minutes apart in 21 patients. The mean difference between the two measurements was 1.7 +/- 12.4 mm3, with a coefficient of variation of 15%. An error of +/-2 frames in the selection of images to be analyzed had little influence on the results. We conclude that the QCA system provides easy-to-achieve standardization of the image acquisition process and sufficient reproducibility for repeated measurement of volume of a coronary artery segment, which can serve as the primary endpoint in clinical trials evaluating atherosclerotic plaque progression or restenosis after angioplasty.

Angioplasty↗
PubMed1995

[Introduction to meta-analytic methodology].

General considerations about meta-analysis and the different steps of this technique are successively discussed: definition of the main objective, identification of the outcome, description of the retrieval and selection of trials, description of the statistical analysis and interpretation of the results. Advantages and drawbacks of the meta-analytical technique are then described: 1) scientific approach, possible quantification of the therapeutic effect, increase of the power of a future clinical trial, synthesis of contradicting results, assessment of the homogeneity, subgroup analysis, analysis of sensibility, scientific collaboration, help for therapeutic information. 2) retrospective approach, inconsistency among trials, potential biases, persistence of some unsolved methodological problems, difficulties for a critical reading and for the interpretation of conclusions. In addition, some examples of published meta-analyses are given to illustrate the advantages and limits mentioned above.

Humans↗
PubMed1995

Ramipril-induced regression of left ventricular hypertrophy in treated hypertensive individuals. HYCAR Study Group.

The objective of this trial was to assess the effects of 6-month daily treatment with two doses of ramipril on left ventricular mass and the dependence of this on blood pressure changes in hypertensive patients with left ventricular hypertrophy. After a selection phase of 4 to 6 weeks with patients under antihypertensive therapy with 20 mg furosemide daily, 115 patients with either controlled or uncontrolled hypertension and left ventricular hypertrophy were randomized in a double-blind manner to receive either placebo (n = 40), 1.25 mg (low dose, n = 38), or 5 mg (regular dose, n = 37) ramipril daily for 6 months. Treatment with furosemide was continued unchanged during this phase. The main outcome measured was left ventricular hypertrophy regression as assessed from central blind reading of echocardiograms recorded at randomization and after 6 months. No significant differences were observed for changes in casual or ambulatory blood pressure between the three groups. Left ventricular mass index was found to be significantly reduced in patients receiving 5 mg ramipril compared with those receiving placebo (-10.8 +/- 3.7 versus +4.1 +/- 4.0 g/m2, P = .008); in patients receiving 1.25 mg ramipril, the difference was close to borderline significance compared with placebo (-7.0 +/- 4.3 g/m2, P = .06). Similar results were observed for changes in left ventricular mass (-20.3 +/- 6.6 and -13.0 +/- 7.8 g in the 5- and 1.25-mg ramipril groups, respectively, versus +9.1 +/- 7.2 g in the placebo group; P = .004 and .04, respectively).(ABSTRACT TRUNCATED AT 250 WORDS)

Blood Pressure↗