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Claims for Patent: 8,795,741

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Claims for Patent: 8,795,741

Title:Methods for treating patients who are candidates for inhaled nitric oxide treatment
Abstract: Disclosed are methods of reducing the risk that a medical treatment comprising inhalation of nitric oxide gas will induce an increase in pulmonary capillary wedge pressure in the patient, leading to pulmonary edema.
Inventor(s): Baldassarre; James S. (Doylestown, PA)
Assignee: INO Therapeutics LLC (Hampton, NJ)
Application Number:13/683,417
Patent Claims: 1. A method of treating patients who are candidates for inhaled nitric oxide treatment, which method reduces the risk that inhalation of nitric oxide gas will induce an increase in pulmonary capillary wedge pressure (PCWP) leading to pulmonary edema in neonatal patients with hypoxic respiratory failure, the method comprising: (a) identifying a plurality of term or near-term neonatal patients who have hypoxic respiratory failure and are candidates for 20 ppm inhaled nitric oxide treatment; (b) determining that a first patient of the plurality does not have left ventricular dysfunction; (c) determining that a second patient of the plurality has left ventricular dysfunction, so is at particular risk of increased PCWP leading to pulmonary edema upon treatment with inhaled nitric oxide; (d) administering 20 ppm inhaled nitric oxide treatment to the first patient; and (e) excluding the second patient from treatment with inhaled nitric oxide, based on the determination that the second patient has left ventricular dysfunction, so is at particular risk of increased PCWP leading to pulmonary edema upon treatment with inhaled nitric oxide.

2. The method of claim 1, wherein the first patient has congenital heart disease.

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

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

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

6. The method of claim 1, wherein determining that the first patient does not have pre-existing left ventricular dysfunction and the second patient does have pre-existing left ventricular dysfunction comprises performing at least one diagnostic process on each of the first and second patients.

7. The method of claim 1, wherein determining that the first patient does not have pre-existing left ventricular dysfunction and the second patient does have pre-existing left ventricular dysfunction comprises performing echocardiography on the first and second patients.

8. The method of claim 1, wherein the second patient has a PCWP that is greater than or equal to 20 mm Hg.

9. A method of treating patients who are candidates for inhaled nitric oxide treatment, which method reduces the risk that inhalation of the nitric oxide gas will induce an increase in PCWP leading to pulmonary edema in neonatal patients with hypoxic respiratory failure, said method comprising: (a) identifying a plurality of term or near-term neonatal patients who have hypoxic respiratory failure and are candidates for 20 ppm inhaled nitric oxide treatment; (b) determining that a first patient of the plurality does not have left ventricular dysfunction; (c) determining that a second patient of the plurality has left ventricular dysfunction, so is at particular risk of increased PCWP leading to pulmonary edema upon treatment with inhaled nitric oxide; (d) administering 20 ppm inhaled nitric oxide treatment to the first patient; and (e) excluding the second patient from treatment with inhaled nitric oxide based on the determination in (c), or, despite the second patient's ongoing need for inhaled nitric oxide treatment for hypoxic respiratory failure, discontinuing the second patient's treatment with inhaled nitric oxide after it was begun, the discontinuation being in view of the determination in (c).

10. The method of claim 9, wherein the discontinuation is in view of both the determination in (c) and the second patient's experiencing an adverse event upon treatment with inhaled nitric oxide.

11. The method of claim 10, wherein the adverse event comprises pulmonary edema.

12. The method of claim 10, wherein the adverse event comprises at least one of increased PCWP, systemic hypotension, bradycardia, or cardiac arrest.

13. The method of claim 9, wherein (c) comprises determining that the second patient has a pulmonary capillary wedge pressure that is greater than or equal to 20 mm Hg.

14. The method of claim 9, wherein the first patient has congenital heart disease.

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

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

17. The method of claim 9, wherein the second patient is determined to be at particular risk not only of increased PCWP leading to pulmonary edema, but also of other serious adverse events, upon treatment with inhaled nitric oxide; and either (i) the second patient is excluded from inhaled nitric oxide treatment based on both the determination in (c) and the determination that the second patient is also at risk of other serious adverse events upon treatment with inhaled nitric oxide; or (ii) despite the second patient's ongoing need for inhaled nitric oxide treatment for hypoxic respiratory failure, the second patient's treatment with inhaled nitric oxide is discontinued after it was begun, the discontinuation being in view of both the determination in (c) and the determination that the second patient is also at risk of other serious adverse events upon treatment with inhaled nitric oxide.

18. The method of claim 17, wherein the other serious adverse events comprise one or more of increased PCWP, systemic hypotension, bradycardia, or cardiac arrest.

19. The method of claim 17, wherein the discontinuation is in view of: the determination in (c), the determination that the second patient is also at risk of other serious adverse events, and the second patient's experiencing an adverse event upon treatment with inhaled nitric oxide.

20. The method of claim 19, wherein the adverse event experienced by the second patient comprises pulmonary edema.

21. The method of claim 19, wherein the adverse event experienced by the second patient comprises at least one of increased PCWP, systemic hypotension, bradycardia, or cardiac arrest.

22. The method of claim 9, wherein determining that the first patient does not have pre-existing left ventricular dysfunction and the second patient does have pre-existing left ventricular dysfunction comprises performing at least one diagnostic process on each of the first and second patients.

23. The method of claim 9, wherein determining that the first patient does not have pre-existing left ventricular dysfunction and the second patient does have pre-existing left ventricular dysfunction comprises performing echocardiography on each of the first and second patients.

24. A method of treating patients who are candidates for inhaled nitric oxide treatment, which method reduces the risk of inducing an increase in PCWP leading to pulmonary edema in neonatal patients with hypoxic respiratory failure, the method comprising: (a) identifying a plurality of term or near-term neonatal patients who have hypoxic respiratory failure and are candidates for 20 ppm inhaled nitric oxide treatment; (b) determining that a first patient of the plurality does not have pre-existing left ventricular dysfunction; (c) administering a first treatment regimen to the first patient, wherein the first treatment regimen comprises administration of 20 ppm inhaled nitric oxide for 14 days or until the first patient's hypoxia has resolved; (d) determining that a second patient of the plurality has pre-existing left ventricular dysfunction, so is at particular risk of increased PCWP leading to pulmonary edema upon treatment with inhaled nitric oxide; and (e) administering a second treatment regimen to the second patient, wherein the second treatment regimen does not comprise either (i) administration of inhaled nitric oxide for 14 days or (ii) administration of inhaled nitric oxide until the second patient's hypoxia has resolved.

25. The method of claim 24, wherein the second treatment regimen does not comprise administration of inhaled nitric oxide.

26. The method of claim 24, wherein the second treatment regimen comprises beginning administration of inhaled nitric oxide but discontinuing the administration upon determination that inhaling nitric oxide has increased the second patient's PCWP and/or induced pulmonary edema in the second patient.

27. The method of claim 24, wherein the first patient has congenital heart disease.

28. The method of claim 24, wherein the pre-existing left ventricular dysfunction of the second patient is attributable to congenital heart disease.

29. The method of claim 24, wherein the diagnostic process comprises echocardiography.

30. The method of claim 24, wherein the second patient has a pulmonary capillary wedge pressure that is greater than or equal to 20 mm Hg.

31. The method of claim 1, wherein identifying the plurality of term or near-term neonatal patients who have hypoxic respiratory failure and are candidates for 20 ppm inhaled nitric oxide treatment comprises performing at least one diagnostic process.

32. The method of claim 9, wherein identifying the plurality of term or near-term neonatal patients who have hypoxic respiratory failure and are candidates for 20 ppm inhaled nitric oxide treatment comprises performing at least one diagnostic process.

33. The method of claim 24, wherein identifying the plurality of term or near-term neonatal patients who have hypoxic respiratory failure and are candidates for 20 ppm inhaled nitric oxide treatment comprises performing at least one diagnostic process.

34. A method of treating patients who are candidates for inhaled nitric oxide treatment, which method reduces the risk that inhalation of nitric oxide gas will induce an increase in pulmonary capillary wedge pressure (PCWP) leading to pulmonary edema, the method comprising: (a) identifying a plurality of patients who are children with a condition that makes them candidates for 20 ppm inhaled nitric oxide treatment; (b) determining that a first patient of the plurality does not have left ventricular dysfunction; (c) determining that a second patient of the plurality has left ventricular dysfunction, so is at particular risk of increased PCWP leading to pulmonary edema upon treatment with inhaled nitric oxide; (d) administering 20 ppm inhaled nitric oxide treatment to the first patient; and (e) excluding the second patient from treatment with inhaled nitric oxide, based on the determination that the second patient has left ventricular dysfunction, so is at particular risk of increased PCWP leading to pulmonary edema upon treatment with inhaled nitric oxide.

35. The method of claim 34, wherein the second patient is determined to be at particular risk not only of increased PCWP leading to pulmonary edema, but also of other serious adverse events, upon treatment with inhaled nitric oxide, and the second patient is excluded from inhaled nitric oxide treatment based on the determination that the second patient has left ventricular dysfunction and so is at particular risk not only of increased PCWP leading to pulmonary edema, but also other serious adverse events, upon treatment with inhaled nitric oxide.

36. The method of claim 34, wherein the left ventricular dysfunction of the second patient is attributable to congenital heart disease.

37. A method of treating patients who are candidates for inhaled nitric oxide treatment, which method reduces the risk that inhalation of the nitric oxide gas will induce an increase in PCWP leading to pulmonary edema in neonatal patients with hypoxic respiratory failure, said method comprising: (a) identifying a plurality of patients who are children with a condition that makes them candidates for 20 ppm inhaled nitric oxide treatment; (b) determining that a first patient of the plurality does not have left ventricular dysfunction; (c) determining that a second patient of the plurality has left ventricular dysfunction, so is at particular risk of increased PCWP leading to pulmonary edema upon treatment with inhaled nitric oxide; (d) administering 20 ppm inhaled nitric oxide treatment to the first patient; and (e) excluding the second patient from treatment with inhaled nitric oxide based on the determination in (c), or, despite the second patient's ongoing need for inhaled nitric oxide treatment for hypoxic respiratory failure, discontinuing the second patient's treatment with inhaled nitric oxide after it was begun, the discontinuation being in view of the determination in (c).

38. The method of claim 37, wherein the discontinuation is in view of both the determination in (c) and the second patient's experiencing an adverse event upon treatment with inhaled nitric oxide.

39. The method of claim 38, wherein the adverse event comprises pulmonary edema.

40. The method of claim 38, wherein the adverse event comprises at least one of increased PCWP, systemic hypotension, bradycardia, or cardiac arrest.

41. The method of claim 37, wherein the left ventricular dysfunction of the second patient is attributable to congenital heart disease.

42. The method of claim 37, wherein the second patient is determined to be at particular risk not only of increased PCWP leading to pulmonary edema, but also of other serious adverse events, upon treatment with inhaled nitric oxide; and either (i) the second patient is excluded from inhaled nitric oxide treatment based on both the determination in (c) and the determination that the second patient is also at risk of other serious adverse events upon treatment with inhaled nitric oxide; or (ii) despite the second patient's ongoing need for inhaled nitric oxide treatment for hypoxic respiratory failure, the second patient's treatment with inhaled nitric oxide is discontinued after it was begun, the discontinuation being in view of both the determination in (c) and the determination that the second patient is also at risk of other serious adverse events upon treatment with inhaled nitric oxide.

43. The method of claim 42, wherein the other serious adverse events comprise one or more of increased PCWP, systemic hypotension, bradycardia, or cardiac arrest.

44. The method of claim 42, wherein the discontinuation is in view of: the determination in (c), the determination that the second patient is also at risk of other serious adverse events, and the second patient's experiencing an adverse event upon treatment with inhaled nitric oxide.
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