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Dronedarone Use Results in More Hospitalizations among Younger Afib Patients

Apr 8, 2015

Patients treated with the heart rhythm drug dronedarone (Multaq) have a higher risk for hospitalization than those treated with amiodarone or other anti-arrhythmic drugs, according to a study involving nongeriatric atrial fibrillation (Afib) patients without cardiovascular disease.

For patients 61 and younger (median age 56), the risk of Afib-related hospitalization was greater with dronedarone than with Class Ic (propafenone and flecainide) drugs (hazard ratio 1.59, 95% CI 1.13-2.24), amiodarone (HR 2.63, 95% CI 1.77-3.89) and sotalol (HR 1.72, 95% CI 1.17-2.54), MedPage Today reports.

Cardiovascular hospitalization risk also was lower with amiodarone (HR 0.80, 95% CI 0.70-0.92) and sotalol (HR 0.63, 95% CI 0.53-0.75) compared with class Ic drugs, researcher Nancy Allen LaPointe, doctor of pharmacy, of Duke Clinical Research Institute, and colleagues wrote in the March issue of Circulation: Cardiovascular Quality and Outcomes.

An earlier placebo-controlled ATHENA clinical trial showed a reduced risk of hospitalization in a largely older (mean age 71.6) Afib population using dronedarone. Dronedarone was approved in 2009 for the treatment of atrial flutter and paroxysmal or persistent atrial fibrillation. The Food and Drug Administration (FDA) directed a change in the drug’s label in late 2011 to warn of an increased risk of death and serious cardiovascular events in patients with permanent Afib. This change came after the manufacturer, Sanofi, discontinued the PALLIS trial early, after researchers observed a twofold increase in deaths among patients with permanent Afib treated with dronedarone. In early 2011, the FDA warned of possible liver injury associated with dronedarone use.

Atrial fibrillation is an irregular, often rapid, heart rate that commonly causes poor blood flow to the body. Afib symptoms often include heart palpitations, shortness of breath and weakness. Although atrial fibrillation itself usually is not life threatening, it is a serious medical condition that sometimes requires emergency treatment, according to the Mayo Clinic. Atrial fibrillation may lead to the formation of blood clots that may circulate to other organs and lead to blocked blood flow. Treatments for Afib include medications and interventions to alter the heart's electrical system.

The new study included 8,562 Afib patients between the ages of 49 and 61 without known heart disease. They were identified using health plan claims, MedPage Today reports. All were prescribed anti-arrhythmic drugs (AADs) from the beginning of 2006 to the end of 2010. Of those patients, 608 study participants were treated with dronedarone, compared with 2,984 patients treated with class Ic drugs, 2,065 patients treated with sotalol, and 2,905 patients treated with amiodarone.

Afib hospitalization and cardiovascular hospitalization rates were lowest those taking amiodarone, but amiodarone users also had the highest rates of all-cause hospitalizations and non-Afib cardiovascular hospitalizations.

Allen LaPointe said more research is needed in younger Afib patients with few comorbidities to better understand the range of effects of various anti-arrhythmic drugs in this population, according to MedPage Today. She said researchers “don't know if we should be treating these patients differently from older patients."

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