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
View PDF10 Cites 6 Cited by
  • 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

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Image

Smart Image Click on the blue labels to locate them in the text.
Viewing Examples
Smart Image
  • 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.

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to view more

PUM

No PUM Login to view more

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

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to view more

Application Information

Patent Timeline
no application Login to view more
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
Who we serve
  • R&D Engineer
  • R&D Manager
  • IP Professional
Why Eureka
  • Industry Leading Data Capabilities
  • Powerful AI technology
  • Patent DNA Extraction
Social media
Try Eureka
PatSnap group products

Browse by: Latest US Patents, China's latest patents, Technical Efficacy Thesaurus, Application Domain, Technology Topic.

© 2024 PatSnap. All rights reserved.Legal|Privacy policy|Modern Slavery Act Transparency Statement|Sitemap