Combination dosage form containing a cholesterol-lowering...

A - Human Necessities – 61 – K

Patent

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A61K 9/14 (2006.01) A61K 9/16 (2006.01) A61K 9/20 (2006.01) A61K 9/24 (2006.01) A61K 9/28 (2006.01) A61K 9/30 (2006.01) A61K 9/48 (2006.01) A61K 9/50 (2006.01) A61K 45/06 (2006.01)

Patent

CA 2461958

An orally administrable pharmaceutical formulation is provided that combines, as active agents, a cholesterol-lowering agent, an inhibitor of the renin- angiotensin system, aspirin, and optionally at least one of vitamin B6, B12, and folate; the active agents are each present in a unit dose appropriate for once-daily dosing, and at least one of the active agents is contained in a dosage unit within the dosage form that physically separates it from the other active agents. The formulation is provided as a simple and convenient therapy to reduce the risk of cardiovascular events in individuals who are at elevated cardiovascular risk, including individuals who have systemic lupus erythematosus. The formulation is also therapeutic for individuals during or immediately following an occurrence of acute myocardial infarction.

L'invention concerne une préparation pharmaceutique administrable oralement qui combine, comme agents actifs, un hypocholestérolémiant, un inhibiteur du système de la rénine-angiotensine, de l'aspirine, et, facultativement, au moins une vitamine sélectionnée parmi des vitamines B6, B12, et un folate. Lesdits agents actifs sont respectivement présents dans une dose unitaire appropriée à une dose quotidienne unique, et au moins un des agents actifs est contenu dans une unité posologique située à l'intérieur de la forme dosifiée qui la sépare physiquement des autres agents actifs. Ladite préparation est conçue comme une thérapie simple et convenable servant à diminuer le risque d'accidents cardio-vasculaires chez des individus qui présentent un risque élevé d'accidents cardio-vasculaires, y compris des individus qui ont un lupus érythémateux disséminé. Cette préparation s'adresse sur le plan thérapeutique à des individus au moment, où ils ont un infarctus du myocarde grave ou immédiatement après cet infarctus.

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