Study Finds Higher Risk of Hospitalization Among Dronedarone UsersApr 8, 2015
A study published in the March issue of Circulation: Cardiovascular Quality and Outcomes found a higher risk of hospitalization among atrial fibrillation patients taking dronedarone compared to other antiarrhythmia drugs. Sanofi sells dronedarone under the brand name Multaq; the drug was approved in 2009 to treat atrial flutter and paroxysmal or persistent atrial fibrillation. MedPage Today reports that the study population was comprised of non geriatric patients with no history of cardiovascular disease, which raises questions about previous findings.
An earlier placebo-controlled ATHENA clinical trial showed that dronedarone was associated with a lower risk of hospitalization in elderly patients (mean age 71.6). This is different from the new study's finding that the drug is linked to an increased hospitalization risk among younger, relatively healthy patients. Lead author Nancy Allen LaPoint, PharmD, of Duke Clinical Research Institute, Durham, N.C. called the findings "hypothesis generating".
"We can't say this (increase in hospitalizations) is cause and effect," Allen said to MedPage Today. "What we can say is that we observed this finding in this younger patient population that requires additional investigation."
Researchers conducted the study by gathering information on 8,562 Afib patients between the ages of 49 and 61 using health plan claims data. All of the participants were prescribed antiarrhythmic drugs from early 2006 to late 2010 and none had a known history of heart disease.
The primary outcome was the length of time between the first prescription to hospitalization for atrial fibrillation. The second outcomes were time to cardiovascular and all-cause hospitalization, MedPage Today reports. The study population was comprised of only 608 dronedarone users, compared to 2,984 taking class Ic drugs (propafenone and flecainide) drugs, 2,065 taking Sotalol and 2,905 taking amiodarone. Dronedarone patients had a higer risk of Afib-related hospitalization compared to those taking class Ic dugs and amiodarone and sotalol users.
The U.S. Food and Drug Administration (FDA) warned in late 2011 that patients with permanent atrial fibrillation may be at risk of serious cardiovascular events and death with dronedarone. This action was prompted by the early discontinuation of the PALLIS trial, in which a twofold increased risk of death was found among patients with permanent Afib taking the drug.