Screening method for identifying patients at risk of adverse...

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G01N 33/68 (2006.01) A61P 3/10 (2006.01) G01N 33/15 (2006.01)

Patent

CA 2735582

This present invention provides methods and kits for identifying patients at risk of suffering from a drug induced liver injury, particularly for an antioxidant drug, or for identifying patients who are suffering from early stages of a liver disorder by assessing the levels of apolipoprotein in a sample of the patient and comparing that to a reference value. The reference value is predetermined by identifying a population sample and determining an upper limit of normal value. This value is then used as a reference point for comparison of apolipoprotein levels from patient samples. In one embodiment, apolipoprotein levels are combined with ATL and/or total bilirubin levels for predicting liver damage, hepatotoxicity or hepatic events after drug administration.

L'invention concerne des procédés et des kits permettant d'identifier les patients risquant une lésion hépatique induite par des médicaments, en particulier un médicament antioxydant, ou permettant d'identifier les patients qui souffrent des premiers stades d'une affection hépatique, par l'évaluation des niveaux d'apolipoprotéine dans un échantillon du patient et la comparaison avec une valeur de référence. Cette valeur est prédéterminée par l'identification d'un échantillon de population et l'établissement d'une limite supérieure de valeur normale On utilise ensuite une telle valeur comme point de référence pour la comparaison de niveaux d'apolipoprotéine tirés d'échantillons de patient. Selon une variante, les niveaux d'apolipoprotéine sont combinés avec des niveaux d'ALT et/ou des niveaux totaux de bilirubine permettant de prévoir les lésions hépatiques, l'hépatotoxicité ou les complications hépatiques après l'administration de médicaments.

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