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Claims for Patent: 8,431,163

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Claims for Patent: 8,431,163

Title:Methods of reducing the risk of occurrence of pulmonary edema associated with inhalation of nitric oxide gas
Abstract: Disclosed are methods of reducing the risk of occurrence of pulmonary edema associated with a medical treatment comprising inhalation of nitric oxide gas.
Inventor(s): Baldassarre; James S. (Doylestown, PA), Rosskamp; Ralf (Chester, NJ)
Assignee: INO Therapeutics LLC (Hampton, NJ)
Application Number:13/651,660
Patent Claims: 1. A method of reducing the risk of occurrence of pulmonary edema associated with a medical treatment comprising inhalation of 20 ppm nitric oxide gas, said method comprising: (a) performing echocardiography to identify a term or near-term neonate patient in need of 20 ppm inhaled nitric oxide treatment for hypoxic respiratory failure, wherein the patient is not dependent on right-to-left shunting of blood; (b) determining that the patient identified in (a) has left ventricular dysfunction consistent with a pulmonary capillary wedge pressure greater than or equal to 20 mm Hg, so is at particular risk of pulmonary edema upon treatment with inhaled nitric oxide; and (c) excluding the patient from inhaled nitric oxide treatment, based on the determination that the patient has left ventricular dysfunction and so is at particular risk of pulmonary edema upon treatment with inhaled nitric oxide.

2. The method of claim 1, wherein the determination in (b) comprises performing echocardiography.

3. The method of claim 1, wherein the patient's left ventricular dysfunction is attributable to congenital heart disease.

4. The method of claim 1, wherein the patient is determined to be at particular risk not only of pulmonary edema, but also of other serious adverse events, upon treatment with inhaled nitric oxide, and the patient is excluded from inhaled nitric oxide treatment based on the determination that the patient has left ventricular dysfunction and so is at particular risk not only of pulmonary edema, but also of other serious adverse events, upon treatment with inhaled nitric oxide.

5. The method of claim 4, wherein the patient's left ventricular dysfunction is attributable to congenital heart disease.

6. A method of treatment comprising: (a) performing echocardiography to identify a plurality of term or near-term neonate patients who are in need of 20 ppm inhaled nitric oxide treatment for hypoxic respiratory failure, wherein the patients are not dependent on right-to-left shunting of blood; (b) determining that a first patient of the plurality has left ventricular dysfunction consistent with a pulmonary capillary wedge pressure greater than or equal to 20 mm Hg, so is at particular risk of pulmonary edema upon treatment with inhaled nitric oxide; (c) determining that a second patient of the plurality does not have left ventricular dysfunction; (d) administering the 20 ppm inhaled nitric oxide treatment to the second patient; and (e) excluding the first patient from treatment with inhaled nitric oxide, based on the determination that the first patient has left ventricular dysfunction, so is at particular risk of pulmonary edema upon treatment with inhaled nitric oxide.

7. The method of claim 6, wherein the second patient has congenital heart disease.

8. The method of claim 6, wherein the left ventricular dysfunction of the first patient is attributable to congenital heart disease.

9. The method of claim 6, wherein the first patient is determined to be at particular risk not only of pulmonary edema, but also of other serious adverse events, upon treatment with inhaled nitric oxide, and the first patient is excluded from inhaled nitric oxide treatment based on the determination that the first patient has left ventricular dysfunction and so is at particular risk not only of pulmonary edema, but also other serious adverse events, upon treatment with inhaled nitric oxide.

10. The method of claim 9, wherein the left ventricular dysfunction of the first patient is attributable to congenital heart disease.

11. The method of claim 6, wherein determining that the first patient of the plurality has pre-existing left ventricular dysfunction and the second patient of the plurality does not have pre-existing left ventricular dysfunction comprises performing echocardiography on the first and second patients.

12. A method of reducing the risk of occurrence of pulmonary edema associated with a medical treatment comprising inhalation of 20 ppm nitric oxide gas, said method comprising: (a) performing echocardiography to identify a term or near-term neonate patient in need of 20 ppm inhaled nitric oxide treatment for hypoxic respiratory failure, wherein the patient is not dependent on right-to-left shunting of blood; (b) determining that the patient identified in (a) has left ventricular dysfunction consistent with a pulmonary capillary wedge pressure greater than or equal to 20 mm Hg, so is at particular risk of pulmonary edema upon treatment with inhaled nitric oxide; and (c) excluding the patient from inhaled nitric oxide treatment, or, despite the patient's ongoing need for treatment for hypoxic respiratory failure, discontinuing the treatment after it has begun, the exclusion or discontinuation being based on the determination that the patient has left ventricular dysfunction and so is at particular risk of pulmonary edema upon treatment with inhaled nitric oxide.

13. The method of claim 12, wherein the determination in (b) comprises performing echocardiography.

14. The method of claim 12, wherein the left ventricular dysfunction is attributable to congenital heart disease.

15. The method of claim 12, wherein the patient is determined to be at particular risk not only of pulmonary edema, but also of other serious adverse events, upon treatment with inhaled nitric oxide, and the patient is excluded from inhaled nitric oxide treatment, or, despite the patient's ongoing need for treatment for hypoxic respiratory failure, the patient's treatment with inhaled nitric oxide is discontinued after it was begun, the exclusion or discontinuation being based on the determination that the patient has left ventricular dysfunction and so is at particular risk not only of pulmonary edema, but also other serious adverse events, upon treatment with inhaled nitric oxide.

16. The method of claim 15, wherein the left ventricular dysfunction of the patient is attributable to congenital heart disease.

17. The method of claim 13, wherein the left ventricular dysfunction of the patient is attributable to congenital heart disease.

18. The method of claim 13, wherein the patient is determined to be at particular risk not only of pulmonary edema, but also of other serious adverse events, upon treatment with inhaled nitric oxide, and the patient is excluded from inhaled nitric oxide treatment, or, despite the patient's ongoing need for treatment for hypoxic respiratory failure, the patient's treatment with inhaled nitric oxide is discontinued after it was begun, the exclusion or discontinuation being based on the determination that the patient has pre-existing left ventricular dysfunction and so is at particular risk not only of pulmonary edema, but also other serious adverse events, upon treatment with inhaled nitric oxide.

19. The method of claim 18, wherein the left ventricular dysfunction of the patient is attributable to congenital heart disease.

20. A method of treatment comprising: (a) performing echocardiography to identify a plurality of term or near-term neonate patients who are in need of 20 ppm inhaled nitric oxide treatment for hypoxic respiratory failure, wherein the patients are not dependent on right-to-left shunting of blood; (b) determining that a first patient of the plurality has left ventricular dysfunction consistent with a pulmonary capillary wedge pressure greater than or equal to 20 mm Hg, so is at particular risk of pulmonary edema upon treatment with inhaled nitric oxide; (c) determining that a second patient of the plurality does not have left ventricular dysfunction; (d) administering the 20 ppm inhaled nitric oxide treatment to the second patient; and (e) excluding the first patient from treatment with inhaled nitric oxide, or, despite the first patient's ongoing need for treatment for hypoxic respiratory failure, discontinuing the first patient's treatment with inhaled nitric oxide after it was begun, the exclusion or discontinuation being based on the determination that the first patient has left ventricular dysfunction, so is at particular risk of pulmonary edema upon treatment with inhaled nitric oxide.

21. The method of claim 20, wherein the second patient has congenital heart disease.

22. The method of claim 20, wherein the left ventricular dysfunction of the first patient is attributable to congenital heart disease.

23. The method of claim 20, wherein the first patient is determined to be at particular risk not only of pulmonary edema, but also of other serious adverse events, upon treatment with inhaled nitric oxide, and the first patient is excluded from inhaled nitric oxide treatment, or, despite the first patient's ongoing need for treatment for hypoxic respiratory failure, the first patient's treatment with inhaled nitric oxide is discontinued after it was begun, the exclusion or discontinuation being based on the determination that the first patient has left ventricular dysfunction and so is at particular risk not only of pulmonary edema, but also other serious adverse events, upon treatment with inhaled nitric oxide.

24. The method of claim 23, wherein the left ventricular dysfunction of the first patient is attributable to congenital heart disease.

25. The method of claim 20, wherein determining that the first patient of the plurality has pre-existing left ventricular dysfunction and the second patient of the plurality does not have pre-existing left ventricular dysfunction comprises performing echocardiography on the first and second patients.
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