Istaroxime-Containing Intravenous Formulation for the Treatment of Pre-Cardiogenic Shock and Cardiogenic Shock
AssigneeWindtree Therapeutics, Inc.
InventorSteven SIMONSON
Life of this patent
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Abstract
Compositions for intravenous infusion of istaroxime in human patients suffering from pre-cardiogenic shock or cardiogenic shock are disclosed. Likewise, methods of administering istaroxime to individuals exhibiting symptoms of, or having been diagnosed with pre-cardiogenic shock or cardiogenic shock are disclosed. In particular, disclosed herein is a method of treating or preventing pre-cardiogenic shock or cardiogenic shock in an individual by administering to the individual a dosage regimen of istaroxime by intravenous infusion for up to 24 hours.
Claims36
1-17. (canceled)
A pharmaceutical composition for treatment of pre-cardiogenic shock or cardiogenic shock in an individual, the pharmaceutical composition comprising:
- (i) a pharmaceutically acceptable carrier;
- and (ii) istaroxime or a pharmaceutically acceptable salt, solvate, or hydrate thereof, wherein the istaroxime or pharmaceutically acceptable salt, solvate, or hydrate thereof is formulated for administration by intravenous infusion at a dose of about 0.2 μg/kg/min to about 2.0 g/kg/min for at least about 6 hours.
20-23. (canceled)
25-27. (canceled)
A method of treating or preventing early cardiogenic shock or cardiogenic shock in an individual, the method comprising:
- a) providing an individual with acute heart failure;
- b) determining that the individual has a systolic blood pressure of less than about 90 mmHg for a first period of time of at least about 1 hour;
- and
- c) administering to the individual a therapeutically effective amount of a pharmaceutical composition comprising:
- (i) a pharmaceutically acceptable carrier;
- and (ii) istaroxime or a pharmaceutically acceptable salt, solvate, or hydrate thereof, wherein the istaroxime or pharmaceutically acceptable salt, solvate, or hydrate thereof is administered at a dose of about 0.2 μg/kg/min to about 2.0 μg/kg/min, and wherein the administering comprises intravenous infusion for a second period of time of at least about 3 hours;
- and
- wherein the administering of the pharmaceutical composition results in an increase over baseline for both systolic heart function and cardiac output, the increase measurable by a third period of time following the start of the intravenous infusion, thereby treating or preventing early cardiogenic shock or cardiogenic shock in the individual.
(canceled)
(canceled)
A method of treating pre-cardiogenic shock in an individual, the method comprising:
- a) providing an individual with pre-cardiogenic shock with acute heart failure, wherein the pre-cardiogenic shock comprises a systolic blood pressure of less than about 90 mm Hg without end-organ hypoperfusion or myocardial infarction;
- b) administering to the individual a therapeutically effective amount of a pharmaceutical composition comprising:
- (i) a pharmaceutically acceptable carrier;
- and (ii) istaroxime or a pharmaceutically acceptable salt, solvate, or hydrate thereof, wherein the istaroxime or pharmaceutically acceptable salt, solvate, or hydrate thereof is administered at a dose of about 0.2 μg/kg/min to about 2.0 μg/kg/min, and wherein the administering comprises intravenous infusion for at least about 6 hours;
- and
- c) measuring one or more parameters of heart function in the individual, wherein the one or more parameters of heart function comprises blood pressure;
- wherein the administering of the pharmaceutical composition results in an increase over baseline for the blood pressure, the increase measurable by 6 hours following the start of the intravenous infusion, thereby treating pre-cardiogenic shock in the individual.
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57-59. (canceled)
Dependencies are inferred from the claim text.