METHOD OF TREATING PATIENTS WITH HEPATORENAL SYNDROME TYPE 1
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 method of treating an adult patient with type 1 hepatorenal syndrome (HRS-1) may include assessing a baseline serum creatinine level prior to administration of terlipressin to the patient, initiating dosing of about 0.5 mg to about 1 mg of terlipressin to the patient every 6 hours by IV for 1-3 days, assessing a serum creatinine level in the patient at day 4±1 day from initiating dosing, administering a modified dosage of terlipressin based on a comparison of the assessed serum creatinine level at day 4±1 day and the baseline serum creatinine level, and continuing administration until 24 hours after two consecutive serum creatinine levels of ≤1.5 mg/dL at least 2 hours apart for a maximum of 14 days. The treatment may result in verified reversal of the HRS-1.
1 . A method of reversing type 1 hepatorenal syndrome (HRS-1), the method comprising:
administering, to a patient having HRS-1, about 0.5 mg to about 1 mg of terlipressin every 6 hours for up to 3 days;
measuring serum creatinine in the patient after 3 days administration; and
comparing the measured serum creatinine to a baseline serum creatinine level, wherein:
if serum creatinine decreased by at least 30%, continue administering about 0.5 mg to about 1 mg terlipressin every 6 hours;
if serum creatinine has not decreased by 30%, administering about 1 mg to about 2 mg of terlipressin every 6 hours; and
if serum creatinine is at or above the baseline serum creatinine level, discontinue administering terlipressin.
2 . The method of claim 1 , wherein the terlipressin administered is terlipressin acetate.
3 . The method of claim 1 further comprising continuing administration of terlipressin until 24 hours after two consecutive measured serum creatinine levels of ≤1.5 mg/dl at least 2 hours apart.
4 . The method of claim 3 , wherein administration of terlipressin to the patient reverses HRS-1.
5 . The method of claim 1 , wherein the terlipressin is administered for a maximum of 14 days.
6 . The method of claim 1 , wherein the terlipressin is administered as an IV bolus injection.
7 . The method of claim 1 , wherein administering terlipressin to the patient provides reversal of one or more complicating factors.
8 . The method of claim 7 , wherein reversal of one or more complicating factors reduces mortality from an associated complication within a 90 day window starting with administering the terlipressin.
9 . The method of claim 1 , wherein the patient does not have renal replacement therapy (RRT) post-liver transplant for at least 10 days after starting administering the terlipressin.
10 . The method of claim 9 , wherein the patient is alive without RRT at day 30 after starting administering the terlipressin.
11 . The method of claim 1 , wherein the patient has Systemic Inflammatory Response Syndrome (SIRS).
12 . The method of claim 1 , further comprising administering to the patient up to a maximum of 100 g per day of albumin each day.
13 . A method of treating type 1 hepatorenal syndrome (HRS-1), the method comprising:
identifying a patient as having HRS-1;
administering, to a patient having HRS-1, about 0.5 mg to about 1 mg of terlipressin every 6 hours for up to 3 days;
measuring serum creatinine in the patient after 3 days administration; and
comparing the measured serum creatinine to a baseline serum creatinine level, wherein:
if serum creatinine decreased by at least 30%, continue administering about 0.5 mg to about 1 mg terlipressin every 6 hours;
if serum creatinine has not decreased by 30%, administering about 1 mg to about 2 mg of terlipressin every 6 hours; and
if serum creatinine is at or above the baseline serum creatinine level, discontinue administering terlipressin.
14 . The method of claim 13 , wherein the terlipressin administered is terlipressin acetate.
15 . The method of claim 13 , further comprising continuing administration of terlipressin until 24 hours after two consecutive measured serum creatinine levels of ≤1.5 mg/dl at least 2 hours apart.
16 . The method of claim 15 , wherein administration of terlipressin to the patient reverses HRS-1.
17 . The method of claim 13 , wherein the terlipressin is administered for a maximum of 14 days.
18 . The method of claim 13 , wherein the patient is administered terlipressin as an IV bolus injection.
19 . The method of claim 13 , wherein the patient experiences HRS reversal, verified HRS reversal, and/or greater than 30% improvement in serum creatinine.
20 . The method of claim 13 , wherein the patient does not have RRT post-liver transplant for at least 10 days after starting administering the terlipressin.
21 . The method of claim 20 , wherein the patient is alive without RRT at day 30 after starting administering the terlipressin.
22 . The method of claim 13 , wherein the patient has SIRS.
23 . The method of claim 13 , further comprising administering to the patient up to a maximum of 100 g per day of albumin each day.
24 . A method of treating an adult patient with type 1 hepatorenal syndrome (HRS-1), the method comprising:
assessing a baseline serum creatinine level prior to administration of terlipressin to the patient;
initiating dosing of about 0.5 mg to about 1 mg of terlipressin to the patient every 6 hours by IV for 1-3 days;
assessing a serum creatinine level in the patient at day 4±1 day from initiating dosing; and
administering a modified dosage of terlipressin based on a comparison of the assessed serum creatinine level at day 4±1 day and the baseline serum creatinine level.
25 . The method of claim 24 , wherein the modified dosage is about 0.5 mg to about 1 mg terlipressin every 6 hours if serum creatinine decreased by at least 30%.
26 . The method of claim 24 , wherein the modified dosage is about 1 mg to about 2 mg terlipressin every 6 hours if serum creatinine has not decreased by 30%.
27 . The method of claim 24 , wherein the modified dosage is a discontinuation of administering terlipressin if serum creatinine is at or above the baseline serum creatinine level.
28 . The method of claim 24 , further comprising continuing administration until 24 hours after two consecutive serum creatinine levels of ≤1.5 mg/dL at least 2 hours apart for a maximum of 14 days.
29 . The method of claim 24 , wherein the terlipressin administered is terlipressin acetate.
30 . The method of claim 24 , wherein administration of terlipressin to the patient reverses HRS-1.
31 . The method of claim 24 , wherein the patient is administered terlipressin as an IV bolus injection.
32 . The method of claim 24 , wherein the patient experiences HRS reversal, verified HRS reversal, and/or greater than 30% improvement in serum creatinine.
33 . The method of claim 24 , wherein the patient does not have RRT post-liver transplant for at least 10 days after starting administering the terlipressin.
34 . The method of claim 33 , wherein the patient is alive without RRT at day 30 after starting administering the terlipressin.
35 . The method of claim 24 , wherein the patient has SIRS.
36 . The method of claim 24 , further comprising administering to the patient up to a maximum of 100 g per day of albumin each day.
37 . A method of treating an adult patient with type 1 hepatorenal syndrome (HRS-1), the method comprising:
assessing a baseline serum creatinine level prior to administration of terlipressin to the patient;
initiating dosing of about 0.5 mg to about 1 mg of terlipressin to the patient every 6 hours by IV for 1-3 days;
assessing a serum creatinine level in the patient at day 4±1 day from initiating dosing;
administering a modified dosage of terlipressin based on a comparison of the assessed serum creatinine level at day 4±1 day and the baseline serum creatinine level; and
continuing administration until 24 hours after two consecutive serum creatinine levels of ≤1.5 mg/dL at least 2 hours apart for a maximum of 14 days.