PubMed · 8353374
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K Gauvreau, M Pagano. Errors in hypothesis testing and power.. https://pubmed.ncbi.nlm.nih.gov/8353374/
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In view of inducing action of hyperlipidemia on progression of nephropathy and relationships between thrombogenesis, atherogenesis and sclerosis, the authors examined fluvastatin effects on platelet-rheological hemostasis. The 12-week course in a dose 20-40 mg/ day produced minimal side effects while its hypolipidemic action was noticeable: a 18, 21 and 20% fall in concentrations of total cholesterol, LDL cholesterol, triglycerides, respectively. The platelet rheology underwent the following changes: spontaneous platelet aggregation went down from 2.58 +/- 0.3 to 1.64 +/- 0.27 r.units, ADP-induced platelet aggregation rose from 6.5 +/- 0.66 to 8.08 +/- 0.77 r.units. No marked changes were registered in hematocrit, plasma and blood density, red cell aggregation and deformability. Thus, active lowering of blood lipids was not associated with evident inhibition of platelet activity. The absence of this feedback in lipid-platelet relations probably indicates an independent significance of hemostatic disturbances in ischemic heart disease and needs further study.
Since 1978, French Health Authorities are supported by external experts committees. Hospital and university experts are organized as advisory boards and are implicated in drug assessment. The French Marketing Authorization Committee is described as an example of such external experts panels.