[Modification of the law of 20/12/88 on the protection of subjects participating in biomedical research].
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Clinical Trials as Topic↗
Biomedical subjects
M Lièvre
Publications and source records attributed to M Lièvre.
[Calcium antagonists in the secondary prevention of myocardial infarction].
We performed a meta-analysis on data from trials of calcium antagonist drugs in the secondary prevention of myocardial infarction. Nifedipine (9,033 patients) increased total mortality non significantly by 12% at the end of follow-up, and by 62% (p = 0.02) before 21 days, with no significant change in the risk of reinfarction. Diltiazem or verapamil did not change total mortality significantly; each of them decreased the risk of reinfarction not significantly (p = 0.06) by approximately 20%. Treatment by either diltiazem or verapamil (8,356 patients) decreased the risk of reinfarction by 21% (p = 0.009). No benefit has been demonstrated with nifedipine in the secondary prevention of myocardial infarction. Verapamil or diltiazem may be an alternative to beta-blockers when these lasts drugs are contra-indicated, although one cannot reasonably expect from the first two drugs a decrease in mortality.
Calcium Channel Blockers↗
[Methodology of preparing a list of educational objectives: example of application to pharmacology. Groupe Objectifs Pédagogiques de L'Association des Enseignants de Pharmacologie].
Using a structured approach to categorize pharmacological knowledge and a systemic analysis of prescribing practice, we identified the knowledge needed to optimally prescribe and manage treatments with drugs. The approach consisted in finding the branched chains of knowledge beginning with each operation required to solve each problem which arises in prescribing and managing drugs at the most elementary level. This elementary knowledge is then transformed into educational objectives. The next step is to share the educational objectives between basic medical training, continuing medical education and acquisition of therapeutic knowledge. The method could be applied in other medical teaching domains.
Educational Technology↗
[Nifedipine and coronary insufficiency: reasons for controversy].
Meta-analyses of Furberg's original data (after correction of two minor errors) were performed using six different methods. Only three of them gave significant results at p < 0.05. The sensitivity analysis showed that taking into account some of the criticisms applied to the original meta-analysis did not change the results. When all the criticisms were considered together, the 95 per cent confidence interval of the odds ratio for mortality was [0.96; 1.31] instead of [1.06; 1.37] originally (p = 0.14 and p = 0.03 respectively), and the dose excess mortality relationship stressed by Furberg disappeared. When the selection of the studies to be entered in a meta-analysis is not straightforward, a sensitivity analysis should be performed.
Angina Pectoris↗
The Eurevie Study: contrasting effect of piretanide and thiazides in mild to moderate hypertension.
UNLABELLED: This study compares the loop diuretic piretanide 6 mg in a slow-release formulation (PIR) with hydrochlorothiazide 25 mg (HCT) and the fixed combination altizide 15 mg-spironolactone 25 mg (ALT-SP) in hypertension. 1105 mild to moderate hypertensive patients entered a three-week placebo wash-out period; 899 were randomized in a 6-month, double-blind, parallel group treatment phase; 800 completed the study. Primary end-points; serum potassium concentration and quality of life at one month; secondary end-points: ionic, renal and metabolic variables; blood pressure (BP) measurements. HCT and ALT-SP were compared only to PIR using Dunnett's or chi 2 tests. RESULTS: No difference was found for the overall quality of life. No change of serum potassium concentration at one month was found in PIR while small decreases were detected with ALT-SP (-0.1 mM) and HCT (-0.26 mM). Serum creatinine concentration increased significantly in ALT-SP when compared to PIR. All the drugs were effective in reducing BP: HCT had a higher rate of responders than PIR with similar mean BP falls and ALT-SP induced greater falls in blood pressure. CONCLUSION: PIR proves to be a potent antihypertensive drug without significant effect on serum electrolytes, plasma glucose and lipids. HCT was slightly more potent but induced a fall in serum potassium concentration with a significant risk of hypokalaemia. The addition of SP to ALT led to a more potent diuretic with a higher level of serum potassium and plasma creatinine disturbances.
Adult↗