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Screening method for identifying patients at risk of adverse hepatologic events

A patient-selected technology, applied in metabolic diseases, disease diagnosis, cardiovascular system diseases, etc., can solve the problem of low specificity of transaminase alone

Inactive Publication Date: 2011-11-23
SALUTRIA PHARMACEUTICALS LLC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Many drugs show increased ALT signaling without risk of serious harm (eg, tacrine, statins, aspirin, heparin), suggesting low specificity for transaminase-raising excess alone

Method used

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  • Screening method for identifying patients at risk of adverse hepatologic events
  • Screening method for identifying patients at risk of adverse hepatologic events
  • Screening method for identifying patients at risk of adverse hepatologic events

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0107] Example 1: Increased ALT alone predicts poor liver toxicity

[0108] Thirty-six patients in the pooled data set of diabetic patients had elevated ATL peaks between 3× and <5×ULN. Data for the treatment groups are summarized in Table 1. AGI-1067- and placebo-treated patients had comparable incidences of ALT elevations in this range. ALT levels are therefore of limited value in assessing potential hepatotoxicity.

[0109] Table 1.

[0110]

Embodiment 2

[0111] Example 2: Elevated ALT Combined with Total Bilirubin Levels Are Useful Indicators of Hepatic Events

[0112] There were 24 diabetic patients in the pooled data set with hepatic events when using ALT > 5X ULN plus TBL 3X ULN plus TBL > 2X ULN criteria. Table 2 summarizes the treatment groups and patients administered AGI-1067. Randomly sampled, 57% of patients were in the AGI-1067 group and 43% in the placebo group, resulting in an AGI-1067 to placebo ratio of 1.3. Of the 24 hepatic events, 17 occurred in AGI-1067-treated patients and 7 occurred in placebo-treated patients.

[0113] Table 2.

[0114] Before using the risk identification tool

[0115]

Embodiment 3

[0116] Example 3: ApoA1 levels are directly related to adverse liver events.

[0117] ApoA1 measurements are both sensitive and specific for identifying subsequent hepatic events. Events were determined when ALT > 5X ULN and TBL 3X ULN and TBL > 2X ULN were measured. figure 1 Cox proportional hazards models generated from data in patients with type 2 diabetes showed an age-adjusted effect of the 5th-95th percentile range of baseline ApoA1 on subsequent hepatic events. As a point of reference, the ULN for ApoAl in this assay is 165 mg / dL. Solid and dashed lines represent AGI-1067 and placebo data, respectively.

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Abstract

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.

Description

[0001] Cross References to Related Applications [0002] This application claims the benefit of US Provisional Application No. 61 / 092,686, filed August 28, 2008, which is hereby incorporated by reference in its entirety. field of invention [0003] The present invention provides screening methods and kits for identifying patients at risk of liver damage, in particular showing increased risk of hepatotoxicity following administration of a drug. The methods and kits can be used to identify patients at risk of drug-induced liver damage in order to exclude such patients from certain treatment regimens. Background of the invention [0004] The drugs sometimes cause severe damage to the patient's liver, with loss of liver function leading to illness, disability, hospitalization, and even life-threatening liver failure and death or the need for a liver transplant. As the world's population ages, more and more drugs are being prescribed, often in combination with self-prescribed ov...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N33/68G01N33/15A61P3/10
CPCG01N2800/085G01N33/92A61P3/10A61P9/00
Inventor R·梅德福K·M·博罗H·迈巴赫
Owner SALUTRIA PHARMACEUTICALS LLC
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