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Claims for Patent: 8,293,284

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Claims for Patent: 8,293,284

Title:Methods of reducing the risk of occurrence of pulmonary edema in term or near-term neonates in need of treatment with inhaled nitric oxide
Abstract: The invention relates methods of reducing the risk or preventing the occurrence of an adverse event (AE) or a serious adverse event (SAE) associated with a medical treatment comprising inhalation of nitric oxide.
Inventor(s): Baldassarre; James S. (Doylestown, PA), Rosskamp; Ralf (Chester, NJ)
Assignee: INO Therapeutics LLC (Hampton, NJ)
Application Number:12/821,041
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 pulmonary hypertension, wherein the patient is not dependent on right-to-left shunting of blood; (b) determining that the patient identified in (a) has a pulmonary capillary wedge pressure greater than or equal to 20 mm Hg and thus has left ventricular dysfunction, 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 step (b) comprises performing echocardiography.

3. The method of claim 1, wherein step (b) comprises measuring the patient's pulmonary capillary wedge pressure.

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

5. 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.

6. 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) carrying out a diagnostic process comprising measuring blood oxygen level, to identify a term or near-term neonate patient as being 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 has a pulmonary capillary wedge pressure greater than or equal to 20 mm Hg and thus has left ventricular dysfunction, so is at particular risk of pulmonary edema upon treatment with inhaled nitric oxide; and (c) excluding the patient from treatment with inhaled nitric oxide 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.

7. The method of claim 6, wherein the diagnostic process of step (a) further comprises performing echocardiography.

8. The method of claim 6, wherein step (b) comprises performing echocardiography.

9. The method of claim 6, wherein step (b) comprises measuring the patient's pulmonary capillary wedge pressure.

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

11. The method of claim 6, 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 other Serious Adverse Events, upon treatment with inhaled nitric oxide.

12. The method of claim 11, wherein the left ventricular dysfunction is attributable to congenital heart disease.

13. 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 pulmonary hypertension, wherein the patients are not dependent on right-to-left shunting of blood; (b) determining that a first patient of the plurality has a pulmonary capillary wedge pressure greater than or equal to 20 mm Hg and thus has left ventricular dysfunction, 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.

14. The method of claim 13, wherein step (a) further comprises measuring blood oxygen levels in the first and second patients and thereby determining that the first and second patients are hypoxic.

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

16. The method of claim 13, wherein the second patient has congenital heart disease.

17. The method of claim 13, wherein step (b) comprises measuring the first patient's pulmonary capillary wedge pressure.

18. The method of claim 13, 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.

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

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

21. The method of claim 13, 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.

22. The method of claim 21, wherein the left ventricular dysfunction of the first patient is attributable to congenital heart disease.

23. A method of treatment comprising: (a) identifying a plurality of term or near-term neonate patients who are in need of 20 ppm inhaled nitric oxide treatment, wherein the patients are not dependent on right-to-left shunting of blood; (b) in a first patient of the plurality, measuring pulmonary capillary wedge pressure to determine that the first patient of the plurality has a pulmonary capillary wedge pressure greater than or equal to 20 mm Hg and thus has left ventricular dysfunction, so is at particular risk of pulmonary edema upon treatment with inhaled nitric oxide; (c) in a second patient of the plurality, performing echocardiography and/or measurement of pulmonary capillary wedge pressure to determine that the 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.

24. The method of claim 23, wherein step (a) comprises performing echocardiography to determine that the first and second patients have pulmonary hypertension.

25. The method of claim 23, wherein step (a) comprises measuring blood oxygen levels in the first and second patients and thereby determining that the first and second patients are hypoxic.

26. The method of claim 23, wherein the second patient has congenital heart disease.

27. The method of claim 23, wherein step (b) comprises measuring the first patient's pulmonary capillary wedge pressure.

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

29. The method of claim 23, 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 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.

30. The method of claim 29, wherein the left ventricular dysfunction of the first patient is attributable to congenital heart disease.
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