Dronedarone in High-Risk Permanent Atrial Fibrillation (PALLAS Trial)
Dronedarone increased rates of heart failure, stroke, and death from cardiovascular causes in patients with permanent atrial fibrillation who were at risk for major vascular events. Our data show that this drug should not be used in such patients.
Dronedarone in Atrial Fibrillation — Jekyll and Hyde? (Editorial)
Has a nice comparison of the ATHENA, PALLAS, and ANDROMEDA studies.
Take home messages:
1) Patients with permanent atrial fibrillation have no reason to receive antiarrhythmic drugs, and on the basis of the PALLAS findings, they should certainly not receive dronedarone;
2) Dronedarone will also need to be avoided in high-risk patients with nonpermanent atrial fibrillation, particularly those with heart failure;
3) Dose adjustment of digoxin is clearly essential in patients taking dronedarone;
4) Reserve dronedarone for selected low-risk patients with persistent or paroxysmal atrial fibrillation, possibly those in whom other antiarrhythmic drugs have failed.
(UPDATE) FDA puts new warnings on Dronedarone
December 19, 2011 (Silver Spring, Maryland) — The FDA is requiring new safety warnings to be included on the labeling for the antiarrythmic drug dronedarone (Multaq, Sanofi-Aventis) in light of clinical data showing the drug increases the risk of serious cardiovascular events, including death, in patients with permanent atrial fibrillation (AF).
The agency is adding the following revisions and recommendations to the drug's label: Healthcare professionals should prescribe the drug only to patients who can be converted into normal sinus rhythm, and the drug should be discontinued in patients in AF. Healthcare professionals should monitor the heart rhythm of patients taking dronedarone by ECG at least once every three months.
Dronedarone is indicated to reduce hospitalization for AF in patients in sinus rhythm with a history of paroxysmal or persistent AF. Patients on dronedarone should also be on appropriate antithrombotic therapy, the FDA insists.
Risks for Stroke, Bleeding, and Death in Patients With Atrial Fibrillation Receiving Dabigatran or Warfarin in Relation to the CHADS2 Score: A Subgroup Analysis of the RE-LY Trial
Higher CHADS2 scores were associated with increased risks for stroke or systemic embolism, bleeding, and death in patients with atrial fibrillation receiving oral anticoagulants.
Learning the Respective Roles of Warfarin and Dabigatran to Prevent Stroke in Patients With Nonvalvular Atrial Fibrillation (Editorial)
1) Dabigatran is more effective and safer for many patients with nonvalvular atrial fibrillation, especially younger patients, patients with CHADS2 scores of 0 or 1, and those in whom the INR is not maintained within the therapeutic range at least 60% of the time;
2) If less frequent INR monitoring can also safely keep patients within the therapeutic range of warfarin at least 70% of the time, warfarin may remain the preferred anticoagulant therapy, especially in patients aged 75 years or older or with CHADS2 scores of 3 or higher.
FDA Approves Rivaroxaban for Stroke Prevention in AF Patients
No comments:
Post a Comment