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

• US 9,107,900 B2
• Filed: 03/19/2013
• Issued: 08/18/2015
• Est. Priority Date: 04/17/2008
• Status: Active Grant

• Current Assignee: Sanofi
• Original Assignee: Sanofi
• Inventors: Radzik, Davide, Van Eickels, Martin, Hamdani, Nacera, Gaudin, Christophe
• Primary Examiner(s): Anderson, James D
• Assistant Examiner(s): FINN, MEGHAN R
• Application Number:
  US13/847,159
• Publication Number:
  US 20130217763A1
• Time in Patent Office: 882 Days
• Field of Search: 514/469
• US Class Current: 1/1
• 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 reducing 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 said patient has structural heart disease, wherein said structural heart disease is coronary heart disease; and

(iv) wherein the patient has (a) an age greater than or equal to 75 or (b) an age greater than or equal to 70 and at least one cardiovascular risk factor selected from the group consisting of;

i. hypertension;

ii. diabetes;

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

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

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

2. The method according to claim 1, wherein the cardiovascular risk factor is diabetes.

3. The method according to claim 1, wherein the cardiovascular risk factor is a history of cerebral stroke or of systemic embolism.

4. The method according to claim 1, wherein the cardiovascular risk factor is a left atrial diameter greater than or equal to 50 mm.

5. The method according to claim 1, wherein the cardiovascular risk factor is a left ventricular ejection fraction less than 40%.

7. The method according to claim 1, wherein the administration of said effective amount of dronedarone or pharmaceutically acceptable salt thereof is maintained for at least 12 months.

6. A method of reducing 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 evening meal, (i) wherein said patient has a history of, or current, paroxysmal or persistent non-permanent atrial fibrillation or flutter;

and (ii) wherein said patient has congestive heart failure defined as NYHA class III; and

(iii) wherein said patient has not been hospitalized for heart failure within the last month.

8. The method according to claim 6, wherein the administration of said effective amount of dronedarone or pharmaceutically acceptable salt thereof is maintained for at least 12 months.

9. A method of reducing a risk of cardiovascular hospitalization for atrial fibrillation in a patient, 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 of reduction of said risk, 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, and (iii) wherein said patient has structural heart disease, wherein said structural heart disease is coronary heart disease; and

(iv) wherein the patient has (a) an age greater than or equal to 75 or (b) an age greater than or equal to 70 and at least one cardiovascular risk factor selected from the group consisting of;

i. hypertension;

ii. diabetes;

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

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

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

10. The method according to claim 9, wherein the cardiovascular risk factor is diabetes.

11. The method according to claim 9, wherein the cardiovascular risk factor is a history of cerebral stroke or of systemic embolism.

12. The method according to claim 9, wherein the cardiovascular risk factor is a left atrial diameter greater than or equal to 50 mm.

13. The method according to claim 9, wherein the cardiovascular risk factor is a left ventricular ejection fraction less than 40%.

14. The method according to claim 9, wherein the administration of said dronedarone or pharmaceutically acceptable salt thereof is maintained for at least 12 months.