2005 AHA Scientific Sessions: EURIDES/ADONIS
Dronedarone, a class III multichannel blocker developed for maintenance of sinus rhythm and ventricular rate control, reduces the risk of all-cause hospitalizations and death in patients with atrial fibrillation/flutter (AF/AFl), according to a post-hoc analysis of 2 randomized, placebo-controlled clinical trials.
Dronedarone, a class III multichannel blocker developed for maintenance of sinus rhythm and ventricular rate control, reduces the risk of all-cause hospitalizations and death in patients with atrial fibrillation/flutter (AF/AFl), according to a post-hoc analysis of 2 randomized, placebo-controlled clinical trials.
The analysis pooled data from EURIDIS (European Trial in Atrial Fibrillation or Flutter Patients Receiving Dronedarone For the Maintenance of Sinus Rhythm), a trial conducted in 612 patients, and ADONIS (American-Australian Trial with Dronedarone In Atrial Fibrillation or Flutter Patients For the Maintenance of Sinus Rhythm), which involved 625 patients. The 2 trials were multicenter, double-blind, placebo-controlled studies with a common protocol designed to assess the efficacy of dronedarone 400 mg twice daily for the maintenance of normal sinus rhythm in patients with AF/AFl.
To be eligible, patients had to be in sinus rhythm for at least 1 hour at the time of randomization and have experienced at least 1 episode of AF/AFl during the previous 3 months.
The main results from EURIDIS and ADONIS were presented at the 2004 European Society of Cardiology Congress. The primary end point-an episode of AF/AFl lasting 10 or more minutes-was achieved by 22% fewer dronedarone recipients (P=.0318) in EURIDIS and 28% fewer dronedarone recipients in ADONIS (P=.0017), compared with placebo.
FDA Issues Complete Response Letter for Onpattro in Heart Failure Indication
October 9th 2023Alnylam Pharmaceuticals will no longer pursue this indication of Onpattro and will instead on focus on a label expansion for Amvuttra, which is in phase 3 development to treat patients with cardiomyopathy of ATTR amyloidosis.
FDA Advisory Committee Backs Use of Onpattro in Heart Failure Indication
September 16th 2023Even though committee members voted in support of Onpattro for patients with cardiomyopathy related to transthyretin-mediated amyloidosis, there were questions about whether it provided a clinically meaningful benefit. The FDA set an action date of Oct. 8, 2023.
