Use of dronedarone for the preparation of a medicament for use in the prevention of cardiovascular hospitalization or of mortality
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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%.
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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.
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Citations
24 Claims
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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%. - View Dependent Claims (2, 3, 4, 5, 6, 9, 10, 11, 12, 14, 19, 22)
- a) NYHA Class IV heart failure or b) hospitalization for heart failure within the last month; and
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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%. - View Dependent Claims (15, 17, 20, 23)
- 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
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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%. - View Dependent Claims (13, 16, 18, 21, 24)
- 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
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