Method of treating patients with hepatorenal syndrome type 1
AssigneeMallinckrodt Hospital Products IP Limited
InventorsKhurram Jamil, Stephen Chris Pappas, Jim Potenziano
Life of this patent
Estimating the term…
Abstract
The principles and embodiments of the present disclosure relate to methods for using terlipressin to treat a patient having impaired renal function associated with liver disease. A patient identified as suffering from HRS-1 is tested to determine if the patient meets at least two out of three criteria, wherein the three criteria include a WBC<4 or >12 cells/4; HR>90 bpm; and any one of HCO3<21 mmol/L or PaCO2<32 mmHg or >20 breaths per minute. If the patient meets at least two of the criteria, he or she is administered terlipressin in an amount effective to produce a reduction in serum creatinine of at least 1.0 mg/dL.
Claims27
A method of reversing type 1 hepatorenal syndrome (HRS-1), the method comprising:
- administering, to a patient having HRS-1 that is Systemic Inflammatory Response Syndrome (SIRS) positive, an amount of terlipressin effective to reverse the HRS-1 in the patient;
- wherein the patient is SIRS positive by exhibiting at least two of the following three criteria:
- (i) a white blood cell count (WBC) less than 4,000 cells/mm3 or greater than 12,000 cells/mm3,
- (ii) a heart rate of greater than 90 beats per minute (BPM), and
- (iii) either a partial pressure of carbon dioxide in the blood (PaCO2) <32 mmHg or a blood bicarbonate (HCO3) level <23 mmol/L;
- wherein the patient does not have overt sepsis, septic shock, or uncontrolled infection, and
- wherein administration of terlipressin to the patient produces a decrease in serum creatinine level to ≤1.5 mg/dl and reverses HRS-1.
A method of treating type 1 hepatorenal syndrome (HRS-1), the method comprising:
- identifying a plurality of patients as having HRS-1;
- determining that a patient of the plurality exhibits at least two of the following three criteria for Systemic Inflammatory Response Syndrome (SIRS):
- (i) a white blood cell count (WBC) less than 4,000 cells/mm3 or greater than 12,000 cells/mm3,
- (ii) a heart rate of greater than 90 beats per minute (BPM), and
- (iii) either a partial pressure of carbon dioxide in the blood (PaCO2) <32 mmHg or a blood bicarbonate (HCO3) level <23 mmol/L;
- determining that the patient does not have overt sepsis, septic shock, or uncontrolled infection;
- determining that, because the patient exhibits at least two of the three criteria and does not have overt sepsis, septic shock, or uncontrolled infection, the HRS-1 of the patient is likely to respond to treatment with terlipressin;
- and
- administering to the patient an amount of terlipressin effective to treat HRS-1 in the patient.
A method of reversing type 1 hepatorenal syndrome (HRS-1), the method comprising:
- administering, to a patient having HRS-1 that is Systemic Inflammatory Response Syndrome (SIRS) positive, an amount of terlipressin effective to reverse the HRS-1 in the patient;
- wherein the patient is SIRS positive by exhibiting at least two of the following three criteria:
- (i) a white blood cell count (WBC) less than 4,000 cells/mm3 or greater than 12,000 cells/mm3,
- (ii) a heart rate of greater than 90 beats per minute (BPM), and
- (iii) either a partial pressure of carbon dioxide in the blood (PaCO2) <32 mmHg or a blood bicarbonate (HCO3) level <23 mmol/L;
- wherein the patient does not have overt sepsis, septic shock, or uncontrolled infection,
- wherein administration of terlipressin to the patient produces a decrease in serum creatinine level to ≤1.5 mg/dl and reverses HRS-1, and
- wherein the patient has improved overall survival as compared to a patient treated with placebo.
Dependencies are inferred from the claim text.