Inorganic nitrite to improve cardiopulmonary hemodynamics

Patent metadata

Field	Value
Publication number	US-11219640-B2
Application number	US-201815954304-A
Country	US
Kind code	B2
Filing date	Apr 16, 2018
Priority date	Feb 28, 2013
Publication date	Jan 11, 2022
Grant date	Jan 11, 2022

Abstract

Disclosed herein are methods for treating acute or chronic heart failure using inorganic nitrite, such as sodium nitrite. The method includes administering to a subject in need of treatment a therapeutically effective amount of inorganic nitrite. The nitrite may be administered by inhalation and may be nebulized. The nitrite may be administered at an emitted dose or in an escalated titrated dose. The nitrite may be a liquid formulation or a dry powder formulation.

First claim

What is claimed is:

1. A method for treating heart failure with preserved ejection fraction (HFpEF) comprising administering by inhalation to a subject having HFpEF a therapeutically effective amount of inorganic nitrite, wherein the nitrite is administered in an escalated titrated dose.

2. The method of claim 1 , wherein the nitrite is nebulized.

3. The method of claim 1 , wherein the nitrite is administered at a first dose, followed by one or more subsequent doses, greater than the first dose, that escalate to a final emitted dose at about 80 mg to about 90 mg.

4. The method of claim 1 , wherein the inhaled nitrite is a liquid formulation.

5. The method of claim 4 , wherein the inhaled nitrite is nebulized.

6. The method of claim 1 , wherein the inhaled nitrite is a dry powder formulation.

7. The method of claim 1 , wherein the nitrite is sodium nitrite.

8. The method of claim 1 , wherein the administration of inorganic nitrite results in a decrease in one or more of right atrial pressure, pulmonary arterial pressure, pulmonary capillary wedge pressure, and pulmonary vascular resistance.

9. The method of claim 1 , wherein the administration of inorganic nitrite results in an improved cardiac index.

10. The method of claim 1 , wherein the administration of inorganic nitrite results in increased exercise capacity.

11. The method of claim 1 , wherein the escalated titrated dose results in a plasma concentration of nitrite of about 4 micromolar to about 15 micromolar nitrite.

12. The method of claim 10 , wherein the increase in exercise capacity is associated with a decrease in one or more of right atrial pressure, pulmonary capillary wedge pressure, or pulmonary vascular resistance.

Assignees

• Univ Of Pittsburgh—Of The Commonwealth System Of Higher Education
• Aires Pharmaceuticals Inc

Inventors

• Gladwin Mark Thomas
• Champion Hunter Clay
• Parsley Edwin

Classifications

• A61K31/04

  Nitro compounds · CPC title

• A61K9/0073

  Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy; (nasal sprays A61K9/0043; inhalation of vapours of volatile or heated drugs, e.g. essential oils or nicotine, A61K9/007; devices A61M) · CPC title

• A61K33/00 Primary

  Medicinal preparations containing inorganic active ingredients · CPC title

• A61K9/007

  Pulmonary tract; Aromatherapy · CPC title

• A61P9/12

  Antihypertensives · CPC title