IP Library › Granted Patent US 10,234,464
Granted Patent B2
US 10,234,464 · App. 15/054,255 · Granted Mar 19, 2019

Marker for statin treatment stratification in heart failure

Inventors: Dirk Block (Bichl, DE); Hans-Peter Brunner (Muenchenstein, CH); Thomas Dieterle (Freiburg, DE); Ursula-Henrike Wienhues-Thelen (Krailling, DE); Christian Zaugg (Rheinfelden, DE); Andre Ziegler (Laeufelfingen, CH)
Assignee: Roche Diagnostics Operations, Inc.
G01N33/6893A61K31/40G01N33/62G01N33/6869G01N33/6872G01N2333/47G01N2333/475G01N2333/495G01N2333/5412G01N2800/325G01N2800/52
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 10,234,464
App. No.
15/054,255
Granted
Mar 19, 2019
Kind
B2
Abstract

The present invention is directed to a method of identifying a patient having heart failure as likely to respond to a therapy comprising a statin. The method is based on measuring the level of at least one marker selected from GDF-15 (Growth Differentiation Factor 15), Urea, SHBG (Sex Hormone-Binding Globulin), Uric acid, PLGF (Placental Growth Factor), IL-6 (Interleukin-6), Transferrin, a cardiac Troponin, sFlt-1 (Soluble fms-like tyrosine kinase-1), Prealbumin, Ferritin, Osteopontin, sST2 (soluble ST2), and hsCRP (high sensitivity C-reactive protein) in a sample from a patient. Further envisaged is a method of predicting the risk of a patient to suffer from death or hospitalization, wherein said patient has heart failure and undergoes a therapy comprising a statin. The method is also based on the measurement of the level of at least one of the aforementioned markers.

Claims (20)

1. A method of treating a human patient having heart failure comprising:

(a) combining a serum or plasma sample from a patient with an antibody or antibodies capable of detection and specific for a biomarker wherein the biomarker is one or more of the following: SHBG (Sex Hormone-Binding Globulin), PLGF (Placental Growth Factor), and/or IL-6 (Interleukin-6);

(b) detecting the antibody/biomarker complex to determine a level of the at least one biomarker selected from SHBG (Sex Hormone-Binding Globulin), PLGF (Placental Growth Factor), IL-6 (Interleukin-6), in the sample;

(c) comparing the level of the at least one marker to a respective reference level;

(d) identifying the patient as more likely to respond to a therapy comprising a statin when the level of the at least one biomarker is indicative for a therapy comprising a statin; and

(e) administering a statin to the identified patient.

2. The method according to claim 1 , wherein the subject has heart failure classified as stage B, C or D according to the ACC/AHA classification, and/or wherein the subject has heart failure classified as NYHA class II, III or IV according to the NYHA classification.

3. The method according to claim 1 , wherein the patient also has coronary artery disease.

4. The method of claim 1 , wherein

i) the at least one biomarker is SHBG, and

a) wherein the patient does not suffer from coronary artery disease, and wherein a level of the biomarker in the sample from the patient below the reference level indicates that the patient is more likely to respond to the therapy comprising a statin, and/or wherein a level of the biomarker in the sample from the patient above the reference level indicates that the patient is less likely to respond to the therapy comprising a statin, or

b) wherein the patient suffers from coronary artery disease, and wherein a level of the biomarker in the sample from the patient above the reference level indicates that the patient is more likely to respond to the therapy comprising a statin, and/or wherein a level of the biomarker in the sample from the patient below the reference level indicates that the patient is less likely to respond to the therapy comprising a statin and/or

ii) the at least one biomarker is PlGF, and wherein a level of the biomarker in the sample from the patient above the reference level indicates that the patient is more likely to respond to the therapy comprising a statin, and/or wherein a level of the biomarker in the sample from the patient below the reference level indicates that the patient is less likely to respond to the therapy comprising a statin, and/or

the at least one biomarker is IL-6, and wherein a level of the biomarker in the sample from the patient above the reference level indicates that the patient is more likely to respond to the therapy comprising a statin, and/or wherein a level of the biomarker in the sample from the patient below the reference level indicates that the patient is less likely to respond to the therapy comprising a statin.

5. The method of claim 1 further comprising a step wherein therapy with a statin is initiated or continued if the patient has been identified as likely to respond to a therapy comprising a statin.

6. The method of claim 1 , wherein the biomarker measured is SHBG (Sex Hormone-Binding Globulin).

7. The method of claim 1 , wherein the biomarker measured is PLGF (Placental Growth Factor).

8. The method of claim 1 , wherein the biomarker measured is IL-6 (Interleukin-6).

9. The method according to claim 1 , wherein the subject has heart failure classified as stage B or C according to the ACC/AHA classification, and/or wherein the subject has heart failure classified as NYHA class II or III according to the NYHA classification.

10. The method according to claim 1 , wherein the patient also has coronary artery disease and wherein the at least one biomarker is PlGF.

Assignments (8)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 1, 2016
From: F. HOFFMANN-LA ROCHE AG
To: ROCHE DIAGNOSTICS OPERATIONS, INC.
Reel/Frame 039301/0975 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 1, 2016
From: ROCHE DIAGNOSTICS GMBH
To: ROCHE DIAGNOSTICS OPERATIONS, INC.
Reel/Frame 039301/0644 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 1, 2016
From: BRUNNER, HANS-PETER
To: MAASTRICHT UNIVERSITY MEDICAL CENTER
Reel/Frame 039301/0738 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 1, 2016
From: MAASTRICHT UNIVERSITY MEDICAL CENTER
To: ROCHE DIAGNOSTICS INTERNATIONAL AG
Reel/Frame 039301/0800 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 1, 2016
From: ZAUGG, CHRISTIAN; ZIEGLER, ANDRE
To: ROCHE DIAGNOSTICS INTERNATIONAL AG
Reel/Frame 039301/0860 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 1, 2016
From: ROCHE DIAGNOSTICS INTERNATIONAL AG
To: ROCHE DIAGNOSTICS OPERATIONS, INC.
Reel/Frame 039301/0920 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 1, 2016
From: DIETERLE, THOMAS
To: F. HOFFMANN-LA ROCHE AG
Reel/Frame 039301/0936 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jul 20, 2016
From: BLOCK, DIRK; WIENHUES-THELEN, URSULA-HENRIKE
To: ROCHE DIAGNOSTICS GMBH
Reel/Frame 039195/0731 →
Priority Claims (1)
EP 13181687 · Aug 26, 2013 · regional
Continuity (2)
Continuation PCTEP2014068090 · Aug 26, 2014
Related Publication 20160169911A1 · Jun 16, 2016