Use of dronedarone for the preparation of a medicament for use in the prevention of cardiovascular hospitalization or of mortality

1. A method of decreasing a risk of cardiovascular hospitalization in a patient, said method comprising administering to said patient an effective amount of dronedarone or a pharmaceutically acceptable salt thereof, twice a day with a morning and an evening meal, wherein said patient does not have severe heart failure, (i) wherein severe heart failure is indicated by: a) NYHA Class IV heart failure or b) hospitalization for heart failure within the last month; and (ii) wherein said patient has a history of, or current, paroxysmal or persistent non-permanent atrial fibrillation or flutter; and (iii) wherein the patient has at least one cardiovascular risk factor selected from the group consisting of:

i. an age greater than or equal to 75;

ii. hypertension;

iii. diabetes;

iv. a history of cerebral stroke or of systemic embolism;

v. a left atrial diameter greater than or equal to 50 mm; and

vi. a left ventricular ejection fraction less than 40%.

2. The method according to claim 1 , wherein said cardiovascular hospitalization is hospitalization for atrial fibrillation.

3. The method according to claim 1 , wherein the administration of dronedarone or pharmaceutically acceptable salt thereof prevents cardiovascular hospitalization.

4. The method according to claim 1 , wherein said patient further receives a diuretic-based treatment.

5. The method according to claim 4 , wherein said diuretic is a non-potassium-sparing diuretic.

6. The method according to claim 1 , wherein the dose of dronedarone administered per day, orally, is less than or equal 800 mg, measured in base form.

7. A method of treating a patient with a recent history of or current atrial fibrillation or flutter, said method comprising administrating to said patient a therapeutically effective amount of dronedarone, or a pharmaceutically acceptable salt thereof, twice a day with a morning and an evening meal, wherein said patient does not have severe heart failure, (i) wherein severe heart failure is indicated by: a) NYHA Class IV heart failure or b) hospitalization for heart failure within the last month, and (ii) wherein said atrial fibrillation or flutter is non-permanent and is paroxysmal or persistent; and (iii) wherein the patient has at least one cardiovascular risk factor selected from the group consisting of:

i. an age greater than or equal to 75;

ii. hypertension;

iii. diabetes;

iv. a history of cerebral stroke or of systemic embolism;

v. a left atrial diameter greater than or equal to 50 mm; and

vi. a left ventricular ejection fraction less than 40%.

8. A method of decreasing a risk of hospitalization for atrial fibrillation in a patient having a history of atrial fibrillation or atrial flutter, said method comprising administering dronedarone, or a pharmaceutically acceptable salt thereof, twice a day with a morning and an evening meal to a patient in need thereof, wherein said patient does not have severe heart failure, (i) wherein severe heart failure is indicated by: a) NYHA Class IV heart failure or b) hospitalization for heart failure within the last month, and (ii) wherein said atrial fibrillation or flutter is non-permanent and is paroxysmal or persistent; and (iii) wherein the patient has at least one cardiovascular risk factor selected from the group consisting of:

i. an age greater than or equal to 75;

ii. hypertension;

iii. diabetes;

iv. a history of cerebral stroke or of systemic embolism;

v. a left atrial diameter greater than or equal to 50 mm; and

vi. a left ventricular ejection fraction less than 40%.

9. The method according to claim 1 , wherein the severe heart failure is indicated by NYHA Class IV heart failure.

10. The method of claim 1 , wherein the administration of said effective amount is maintained for at least 12 months.

11. The method of claim 1 , wherein the administration of said effective amount of dronedarone or a pharmaceutically acceptable salt thereof is maintained to decrease the risk of cardiovascular hospitalization.

12. The method according to claim 1 , wherein said patient has a history of paroxysmal or persistent atrial fibrillation or atrial flutter.

13. The method of claim 8 , wherein the dose of dronedarone administered per day, orally, is less than or equal 800 mg, measured in base form.

14. The method claim 1 , wherein the severe heart failure is indicated by hospitalization for heart failure within the last month.

15. The method of claim 7 , wherein the severe heart failure is indicated by NYHA Class IV heart failure.

16. The method of claim 8 , wherein the severe heart failure is indicated by NYHA Class IV heart failure.

17. The method of claim 7 , wherein the severe heart failure is indicated by hospitalization for heart failure within the last month.

18. The method of claim 8 , wherein the severe heart failure is indicated by hospitalization for heart failure within the last month.

19. The method according to claim 1 , wherein the risk factor is an age greater than or equal to 75.

20. The method according to claim 7 , wherein the risk factor is an age greater than or equal to 75.

21. The method according to claim 8 , wherein the risk factor is an age greater than or equal to 75.

22. The method according to claim 1 , wherein the risk factor is hypertension.

23. The method according to claim 7 , wherein the risk factor is hypertension.

24. The method according to claim 8 , wherein the risk factor is hypertension.