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

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.

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.