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

• US 8,410,167 B2
• Filed: 04/16/2009
• Issued: 04/02/2013
• Est. Priority Date: 04/17/2008
• Status: Active Grant

• Current Assignee: Sanofi
• Original Assignee: Sanofi
• Inventors: Radzik, Davide, Gaudin, Christophe, Hamdani, Nacra, Van Eickels, Martin
• Primary Examiner(s): Lundgren, Jeffrey S.
• Assistant Examiner(s): FINN, MEGHAN R
• Application Number:
  US12/425,125
• Publication Number:
  US 20100048694A1
• Time in Patent Office: 1,447 Days
• Field of Search: 514/183
• US Class Current: 514/461
• CPC Class Codes: A61K 31/343 condensed with a carbocyclic ring, e.g. coumaran, bufuralol, befunolol, clobenfurol, amiodarone
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61P 9/00 Drugs for disorders of the cardiovascular system
• CPC Class Codes: A61P 9/04 Inotropic agents, i.e. stimulants of cardiac contraction; Drugs for heart failure
• CPC Class Codes: A61P 9/06 Antiarrhythmics
• CPC Class Codes: A61P 9/10 for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis

Abstract

Methods of using dronedarone or a pharmaceutically acceptable salt thereof, for the preparation of a medicament for use in the prevention of cardiovascular hospitalization or of mortality, articles of manufacture and packages related thereto.

Claims

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.

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.

14. The method claim 1, 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.

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

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%.

15. The method of claim 7, 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.

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

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

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%.

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.

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

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

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

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