USE OF DRONEDARONE FOR THE PREPARATION OF A MEDICAMENT FOR USE IN THE PREVENTION OF CARDIOVASCULAR HOSPITALIZATION OR OF MORTALITY

1 . A method of promoting the use of dronedarone or a pharmaceutically acceptable salt thereof, the method comprising the step of conveying to a recipient at least one message selected from the group consisting of:

a) a primary endpoint of a study of dronedarone, or a pharmaceutically acceptable salt thereof, was the time to first hospitalization for cardiovascular reasons or death from any cause;

b) a secondary endpoint of a study of dronedarone, or pharmaceutically acceptable salt thereof, was death from any cause;

c) a secondary endpoint of a study of dronedarone, or a pharmaceutically acceptable salt thereof, was time to death from any cause;

d) a secondary endpoint of a study of dronedarone, or a pharmaceutically acceptable salt thereof, was time to cardiovascular death;

e) a secondary endpoint of a study of dronedarone, or a pharmaceutically acceptable salt thereof, was time to first hospitalization for cardiovascular reasons;

f) a secondary endpoint of a study of dronedarone, or a pharmaceutically acceptable salt thereof, was time to first hospitalization for atrial fibrillation and other supraventricular rhythm disorders;

g) a secondary endpoint of a study of dronedarone, or a pharmaceutically acceptable salt thereof, was time to first hospitalization for worsening heart failure;

h) a secondary endpoint of a study of dronedarone, or a pharmaceutically acceptable salt thereof, was time to first hospitalization for myocardial infarction;

i) a secondary endpoint of a study of dronedarone, or a pharmaceutically acceptable salt thereof, was time to first hospitalization for myocardial infarction;

j) a secondary endpoint of a study of dronedarone, or a pharmaceutically acceptable salt thereof, was time to first hospitalization for transient ischemic event or cerebral stroke; and

k) a secondary endpoint of a study of dronedarone, or a pharmaceutically acceptable salt thereof, was time to sudden death.

2 . A method of promoting the use of dronedarone or a pharmaceutically acceptable salt thereof, the method comprising the step of conveying to a recipient at least one message selected from the group consisting of:

a. dronedarone, or a pharmaceutically acceptable salt thereof, reduced the combined endpoint of cardiovascular hospitalization or death from any cause by about 24 percent;

b. dronedarone, or a pharmaceutically acceptable salt thereof, reduced the combined endpoint of cardiovascular hospitalization or death from any cause by 24.2 percent;

c. dronedarone, or a pharmaceutically acceptable salt thereof, reduced the combined endpoint of cardiovascular hospitalization or death from any cause by 24.2 percent, driven by a reduction in cardiovascular hospitalization;

d. the total duration of hospitalization was lower with dronedarone when compared to placebo;

e. patients with NYHA Class Ill heart failure at baseline showed a reduction in cardiovascular hospitalization or death; and

f. the risk of hospitalization for heart failure was less in the dronedarone group, or a pharmaceutically acceptable salt thereof, when compared to the placebo group.

3 . The method according to claim 1 or 2 , wherein the message is provided in a label or package insert.

4 . A method of providing dronedarone or a pharmaceutically acceptable salt thereof, wherein said dronedarone or pharmaceutically acceptable salt thereof is provided along with information indicating that dronedarone or pharmaceutically acceptable salt thereof is indicated in patients with a recent history of or current atrial fibrillation or flutter and without severe heart failure.

5 . The method according to claim 4 wherein the information indicates that the atrial fibrillation or flutter is non-permanent.

6 . The method according to claim 4 wherein the information indicates that the atrial fibrillation or flutter is associated with at least one risk factor.

7 . The method according to any one of claims 4 to 6 wherein the information indicates that severe heart failure is indicated by one or more of the following:

a) a history of, or current symptoms of congestive heart failure;

b) symptoms of heart failure with minimal exertion within the last month;

c) hospitalization of the patient for heart failure within the last month;

d) hospitalization of the patient for NYHA Class IV heart failure;

e) hospitalization of the patient for NYHA Class III heart failure within the last month; and

f) hospitalization of the patient for heart failure with recent decompensation as indicated by the need for hospitalization or intravenous therapy.

8 . The method according to claim 4 wherein the information comprises printed matter that advises that dronedarone or a pharmaceutically acceptable salt thereof is indicated in patients with either a recent history of or current atrial fibrillation or flutter with associated risk factors and without severe heart failure.

9 . The method according to claim 8 wherein said printed matter is a label.

10 . A method of promoting the use of dronedarone or a pharmaceutically acceptable salt thereof, the method comprising the step of conveying to a recipient at least one message selected from the group consisting of:

(a) dronedarone or a pharmaceutically acceptable salt thereof should be prescribed to a patient who has not been diagnosed with severe heart failure;

(b) dronedarone or a pharmaceutically acceptable salt thereof is contraindicated in patients with a history of, or current symptoms of congestive heart failure;

(c) dronedarone or a pharmaceutically acceptable salt thereof is contraindicated in patients with severe heart failure;

(d) dronedarone or a pharmaceutically acceptable salt thereof is contraindicated in patients with symptoms of heart failure with minimal exertion within the last month;

(e) dronedarone or a pharmaceutically acceptable salt thereof is contraindicated in patients who were hospitalized for heart failure within the last month;

(f) dronedarone or a pharmaceutically acceptable salt thereof is contraindicated in patients who were hospitalized for NYHA Class IV heart failure;

(g) dronedarone or a pharmaceutically acceptable salt thereof is contraindicated in patients who were hospitalized for NYHA Class III heart failure within the last month;

(h) dronedarone or a pharmaceutically acceptable salt thereof is contraindicated in patients who were hospitalized for heart failure with recent decompensation as indicated by the need for hospitalization or intravenous therapy; and

(i) dronedarone or a pharmaceutically acceptable salt thereof is contraindicated in patients who were hospitalized for heart failure with recent decompensation requiring hospitalization or intravenous therapy for the treatment of heart failure.