Comment
Author: Admin | 2025-04-28
Or when Multaq should be used in managing afib patients.Of interest is that one of the co-authors, Dr. Kaul, actually voted in favor of Multaq as a member of the FDA Advisory Committee that recommended that the FDA should approve it.1Let’s look at the three primary issues the JACC article raised: safety, efficacy and when to try Multaq.Multaq’s Safety and EfficacyIn pointing to pooled data from six dronedarone trials, Dr. Singh said, “These data suggest that dronedarone has modest antiarrhythmic efficacy (effectiveness),” and that it is only half as effective as amiodarone. He conceded that Multaq may “lower the risk of some clinical outcomes” (clinical outcomes are health status changes in those who took the medication), but that the relatively modest efficacy in preventing recurrence of atrial fibrillation and atrial flutter makes the drug’s role in the management of afib and atrial flutter “uncertain.”Singh also expressed skepticism about the drug’s role in managing atrial fibrillation due to “questions regarding its short-term and long-term safety in at-risk patients.” This refers to the ANDROMEDA trial (Antiarrhythmic Trial With Dronedarone in Moderate-to-Severe Congestive Heart Failure Evaluating Morbidity Decrease), which was stopped early due to deaths in this high-risk population.It is worth noting that the ANDROMEDA trial wasn’t an atrial fibrillation trial—it was a heart failure trial—and thus would not apply to the vast majority of atrial fibrillation patients as they are at much lower risk. Singh indicated that the ATHENA trial (A Placebo-Controlled, Double-Blind, Parallel Arm Trial to Assess the Efficacy of Dronedarone 400 mg bid for the Prevention of Cardiovascular Hospitalization or Death From Any Cause in Patients With Atrial Fibrillation / Atrial Flutter) was a subsequent trial “to define a population for which dronedarone may be safely used.”However, Dr. Christian Torp-Pedersen, a member of the steering committee of the ANDROMEDA and ATHENA trials, and his coauthors argued that the ATHENA trial demonstrates Multaq’s safety. In their commentary in the same April 2010 issue of the Journal of the American College of Cardiology, Antiarrhythmic Drugs: Safety First, they stated that ATHENA “is the first large trial to provide safety data in a moderate risk population that comprises a large part of the relevant patients for rhythm control therapy.”On efficacy, Dr. Torp-Pedersen agrees that the evidence shows that Multaq does not work as well when compared to its predecessor, amiodarone, and that Multaq is “clearly less efficacious in maintaining sinus rhythm,” and he
Add Comment