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 . An article of manufacture comprising
 a) a packaging material;   b) dronedarone or a pharmaceutically acceptable salt thereof; and   c) a label or package insert contained within the packaging material indicating that dronedarone or a pharmaceutically acceptable salt thereof is contraindicated in patients with severe heart failure.   
     
     
         2 . The article according to  claim 1  wherein the packaging material indicates that that dronedarone or a pharmaceutically acceptable salt thereof is contraindicated in patients with severe heart failure 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; 
 f) hospitalization of the patient for heart failure with recent decompensation as indicated by the need for hospitalization or intravenous therapy; and 
 g) hospitalization of the patient for heart failure with recent decompensation requiring hospitalization or intravenous therapy for the treatment of heart failure. 
 
     
     
         3 . The article according to  claim 1  wherein the packaging material indicates that dronedarone or a pharmaceutically acceptable salt thereof is contraindicated in patients with severe heart failure indicated by hospitalization of the patient for NYHA Class IV heart failure. 
     
     
         4 . The article according to  claim 1  wherein the packaging material indicates that dronedarone or a pharmaceutically acceptable salt thereof is contraindicated in patients with severe heart failure indicated by hospitalization of the patient for NYHA Class III heart failure within the last month. 
     
     
         5 . A package comprising dronedarone or a pharmaceutically acceptable salt thereof and a label, said label comprising a printed statement which informs a prospective user that dronedarone or a pharmaceutically acceptable salt thereof is contraindicated in patients with severe heart failure. 
     
     
         6 . The package according to  claim 5  wherein the printed statement informs a prospective user of one or more of the following:
 a) that dronedarone or a pharmaceutically acceptable salt thereof is contraindicated in patients with severe heart failure indicated by a history of, or current symptoms of congestive heart failure; 
 b) that dronedarone or a pharmaceutically acceptable salt thereof is contraindicated in patients with severe heart failure indicated by symptoms of heart failure with minimal exertion within the last month; 
 c) that dronedarone or a pharmaceutically acceptable salt thereof is contraindicated in patients with severe heart failure indicated by hospitalization for heart failure within the last month; 
 d) that dronedarone or a pharmaceutically acceptable salt thereof is contraindicated in patients with severe heart failure indicated by NYHA Class IV; 
 e) that dronedarone or a pharmaceutically acceptable salt thereof is contraindicated in patients with severe heart failure indicated by NYHA Class III within the last month; 
 f) that dronedarone or a pharmaceutically acceptable salt thereof is contraindicated in patients with severe heart failure indicated by recent decompensation as indicated by the need for hospitalization or intravenous therapy; and 
 g) 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. 
 
     
     
         7 . A package comprising dronedarone or a pharmaceutically acceptable salt thereof and a label, said label comprising 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.   
     
     
         8 . A package comprising dronedarone or a pharmaceutically acceptable salt thereof and a label, said label comprising 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 III 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.