Marker for statin treatment stratification in heart failure

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.

1 . A method of identifying a patient having heart failure as likely to respond to a therapy comprising a statin comprising:
 (a) measuring a level of at least one biomarker selected from the group consisting of GDF-15 (Growth Differentiation Factor 15), a cardiac Troponin, Osteopontin, and sST2 (soluble ST2) in a sample from the patient;   (b) comparing the level of the at least one marker to a reference level;   (c) identifying a patient who is likely to respond to a therapy comprising a statin based on the results of the comparison step, 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; and   (d) identifying the patient as more likely to respond to the therapy, treating the identified patient with a statin.   
     
     
         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. 
     
     
         3 . The method according to  claim 1 , wherein the patient also has coronary artery disease. 
     
     
         4 . The method of  claim 1 , wherein the statin is selected from the group consisting of Atorvastatin, Cerivastatin, Fluvastatin, Lovastatin, Mevastatin, Pitavastatin, Pravastatin, Rosuvastatin and Simvastatin. 
     
     
         5 . The method of  claim 1 , wherein the patient has been treated with a statin prior to obtaining the sample. 
     
     
         6 . The method of  claim 1 , wherein the patient has not been treated with a statin prior to obtaining the sample. 
     
     
         7 . The method of  claim 1 , wherein the sample is a blood, serum or plasma sample. 
     
     
         8 . The method of  claim 1 , wherein the patient is a human. 
     
     
         9 . The method of  claim 1 , wherein the subject has heart failure classified as NYHA class II, III or IV. 
     
     
         10 . The method of  claim 1 , wherein the subject has heart failure classified as NYHA class II or III. 
     
     
         11 . The method of  claim 1 , wherein the patient is more likely to respond to the therapy comprising a statin if the therapy reduces the risk of mortality of the patient and/or reduces the risk of hospitalization of the patient within a period of 18 months after sample is measured. 
     
     
         12 . The method of  claim 11 , wherein the therapy reduces the risk of the patient and/or reduces the risk of hospitalization of the patient within a period of 3 years after the sample is measured. 
     
     
         13 . A device for carrying out the method of  claim 1 , said device comprising
 a) an analyzer unit comprising at least one binding agent which specifically binds to the at least one biomarker selected from the group consisting of GDF-15 (Growth Differentiation Factor 15), a cardiac Troponin, Osteopontin, and sST2 (soluble ST2), said unit being adapted for measuring the level of the biomarker in a sample of a patient having heart failure, and   b) an analyzer unit for comparing the determined level with a reference level, whereby a patient is identified as more or less likely to respond to a therapy comprising a statin, said unit comprising a database with a reference level and a computer-implemented diagnostic algorithm for carrying out the comparison.