Methods for reducing the risk of an adverse dronedarone / beta-blockers interaction in a patient suffering from atrial fibrilation

Abstract

The disclosure relates to a method for managing the risk of dronedarone/beta-blockers interaction by using dronedarone or pharmaceutically acceptable salts thereof in patients with paroxysmal or persistent atrial fibrillation (AF) or atrial flutter (AFL), with a recent episode of AF/AFL and associated cardiovascular risk factors, who are in sinus rhythm or who will be cardioverted to reduce the risk of cardiovascular hospitalization, said patients also expecting to receive a beta-blockers treatment, by performing the following steps: a—initiate beta-blockers treatment at a low dose; b—performing a electrocardiogram (ECG) verification of good tolerability; c—increase of beta-blockers dose only if results in step b) are satisfying.

What is claimed is: 
     
         1 . A method of providing dronedarone or pharmaceutically acceptable salt or ester thereof, wherein said dronedarone or pharmaceutically acceptable salt or ester thereof is provided along with information indicating that it is useful for treating patients with paroxysmal or persistent atrial fibrillation (AF) or atrial flutter (AFL), with a recent episode of AF/AFL and associated cardiovascular risk factors, who are in sinus rhythm or who will be cardioverted to reduce the risk of cardiovascular hospitalization, and in case said patients also receive a beta-blockers treatment, the following steps should be observed:
 a—initiate beta-blockers treatment at a low dose;   b—performing ECG verification of good tolerability;   c—increase of beta-blockers dose only if results in step b) are satisfying.   
     
     
         2 . The method according to  claim 1 , wherein the pharmaceutically acceptable salt of dronedarone is hydrochloride. 
     
     
         3 . The method according to  claim 1 , wherein the information comprises printed matter that advises that dronedarone or pharmaceutically acceptable salt or ester thereof is useful for treating patients with paroxysmal or persistent atrial fibrillation (AF) or atrial flutter (AFL), with a recent episode of AF/AFL and associated cardiovascular risk factors, who are in sinus rhythm or who will be cardioverted to reduce the risk of cardiovascular hospitalization, and in case said patients also receive a beta-blockers treatment, the following steps should be observed:
 a—initiate beta-blockers treatment at a low dose;   b—performing ECG verification of good tolerability;   c—increase of beta-blockers dose only if results in step b) are satisfying.   
     
     
         4 . A method of promoting the use of dronedarone or pharmaceutically acceptable salts or esters thereof, the method comprising the step of conveying to a recipient at least one message comprising dronedarone or pharmaceutically acceptable salt or ester thereof is useful for treating patients with paroxysmal or persistent atrial fibrillation (AF) or atrial flutter (AFL), with a recent episode of AF/AFL and associated cardiovascular risk factors, who are in sinus rhythm or who will be cardioverted to reduce the risk of cardiovascular hospitalization, and in case said patients also receive a beta-blockers treatment, the following steps should be observed:
 a—initiate beta-blockers treatment at a low dose;   b—performing ECG verification of good tolerability;   c—increase of beta-blockers dose only if results in step b) are satisfying.   
     
     
         5 . The method according to  claim 4 , wherein the pharmaceutically acceptable salt of dronedarone is hydrochloride. 
     
     
         6 . An article of manufacture comprising
 a) a packaging material;   b) dronedarone or pharmaceutically acceptable salt or ester thereof or, and   c) a label or package insert contained within the packaging material indicating that:   
       i) dronedarone or pharmaceutically acceptable salt or ester thereof is indicated in patients with paroxysmal or persistent atrial fibrillation (AF) or atrial flutter (AFL), with a recent episode of AF/AFL and associated cardiovascular risk factors, who are in sinus rhythm or who will be cardioverted to reduce the risk of cardiovascular hospitalization, and 
       ii) in case said patients also expect to receive a beta-blockers treatment, the following steps should be observed:
 a—initiate beta-blockers treatment at a low dose; 
 b—performing ECG verification of good tolerability; 
 c—increase of beta-blockers dose only if results in step b) are satisfying. 
 
     
     
         7 . An article according to  claim 6 , wherein the pharmaceutically acceptable salt of dronedarone is hydrochloride. 
     
     
         8 . A package comprising dronedarone or pharmaceutically acceptable salt or ester thereof and a label, said label comprising a printed statement which informs a prospective user that: 
       i) dronedarone or pharmaceutically acceptable salt or ester thereof is indicated in patients with paroxysmal or persistent atrial fibrillation (AF) or atrial flutter (AFL), with a recent episode of AF/AFL and associated cardiovascular risk factors, who are in sinus rhythm or who will be cardioverted to reduce the risk of cardiovascular hospitalization, and 
       ii) in case said patients also receive a beta-blockers treatment, the following steps should be observed:
 a—initiate beta-blockers treatment at a low dose; 
 b—performing ECG verification of good tolerability; 
 c—increase of beta-blockers dose only if results in step b) are satisfying. 
 
     
     
         9 . A package according to  claim 8 , wherein the pharmaceutically acceptable salt of dronedarone is hydrochloride. 
     
     
         10 . A method for administering a combination of a beta blocker and dronedarone or a pharmaceutically acceptable salt thereof to a patient in need thereof, wherein said method comprises the following steps:
 a—initiating beta-blockers treatment at a low dose;   b—performing ECG verification of good tolerability; and   c—increasing beta-blocker dose only if results in step b) are satisfying.   
     
     
         11 . The method according to  claim 10 , wherein the pharmaceutically acceptable salt of dronedarone is hydrochloride. 
     
     
         12 . The method according to  claim 1 , wherein the beta-blocker is metoprolol or propranolol. 
     
     
         13 . The method according to  claim 4 , wherein the beta-blocker is metoprolol or propranolol. 
     
     
         14 . The method according to  claim 10 , wherein the beta-blocker is metoprolol or propranolol.