Administration of an anti-endotoxin drug by bolus or intermittent intravenous infusion

Abstract

The invention provides methods for administering an anti-endotoxin drug, E5564, by bolus or intermittent intravenous infusion. The methods can be used for treating conditions such as endotoxemia, sepsis, and septic shock.

What is claimed is:  
     
         1 . A method of treating a human patient who has or is at risk of developing a medical condition that is amenable to treatment with Compound E5564, said method comprising administering Compound E5564 to said patient by bolus or intermittent intravenous infusion.  
     
     
         2 . The method of  claim 1 , wherein said administration is by bolus infusion of 0.4-60, 6-56, or 12-28 mg drug.  
     
     
         3 . The method of  claim 2 , wherein said administration is over the course of 4 hours.  
     
     
         4 . The method of  claim 1 , wherein said administration is by intermittent infusion, comprising administration of a loading dose, followed by a maintenance dose.  
     
     
         5 . The method of  claim 4 , wherein said loading dose is 0.4-60 mg, 6-56 mg, or 12-28 mg drug.  
     
     
         6 . The method of  claim 4 , wherein said loading dose is administered over a period of 4 hours.  
     
     
         7 . The method of  claim 4 , further comprising administration of a second loading dose at about 12 or 24 hours after the first loading dose.  
     
     
         8 . The method of  claim 7 , wherein the second loading dose is 0.4-60 mg, 6-56 mg, or 12-28 mg drug, administered over a period of 2 hours.  
     
     
         9 . The method of  claim 4 , wherein the maintenance dose is administered over a period of 2 hours, about 12 hours after the previous loading dose.  
     
     
         10 . The method of  claim 9 , further comprising administration of an additional maintenance dose or additional maintenance doses, that are each administered over a period of 2 hours, about 12 hours from the previous maintenance dose.  
     
     
         11 . The method of  claim 4 , wherein a first loading dose of 3 mg/hour is administered for 4 hours, followed by a second loading dose of 3 mg/hour for 2 hours at about 12 hours after the first loading dose, followed by a maintenance dose of 1.5 mg/hour for 2 hours at about 12, 24, 36, 48, 60, 72, 84, 96, and 108 hours after the second loading dose.  
     
     
         12 . The method of  claim 1 , wherein said patient is a surgical patient; has or is at risk of developing endotoxemia, sepsis, or septic shock; is infected with HIV; or is suffering from an immunological disorder.  
     
     
         13 . The method of  claim 12 , wherein said surgical patient is a cardiac surgical patient.  
     
     
         14 . The method of  claim 12 , wherein said surgical patient is suffering from endotoxemia or acute graft-versus-host disease.