Middle-aged Dronedarone Users Have Higher Risk of Hospitalization

Middle-aged Dronedarone Users Have Higher Risk

New study results reveal that patients age 61 and younger treated with the heart rhythm drug dronedarone (Multaq) have a higher risk for hospitalization than those with treated other anti-arrhythmic drugs.

The study, published in Circulation: Cardiovascular Quality and Outcomes, involved nongeriatric atrial fibrillation (Afib) patients without cardiovascular disease. The risk for Afib-related hospitalization in patients 61 and younger was greater with dronedarone than with Class Ic drugs (propafenone and flecainide), (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.

Nancy Allen LaPointe, doctor of pharmacy, of Duke Clinical Research Institute, and her colleagues wrote in the March issue of Circulation that cardiovascular hospitalization risk 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. A placebo-controlled ATHENA clinical trial showed a reduced risk of hospitalization in a largely older (mean age 71.6) Afib population taking dronedarone.

The Food and Drug Administration approved dronedarone in 2009 for the treatment of atrial flutter and paroxysmal or persistent atrial fibrillation. In late 2011, the FDA directed a change in the drug’s label to warn of an increased risk of death and serious cardiovascular events in patients with permanent Afib. Sanofi, the drug’s manufacturer has discontinued a PALLIS trial early after researchers observed a twofold increase in deaths among patients with permanent Afib treated with dronedarone. That year, the FDA also 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. Symptoms often include heart palpitations, shortness of breath and weakness, according to the Mayo Clinic. Although atrial fibrillation itself usually is not life threatening, it is a serious medical condition and sometimes requires emergency treatment. Atrial fibrillation may lead to the formation of blood clots that may circulate to other organs and lead to blocked blood flow. Treatments for the condition include medications and interventions to regulate the heart’s electrical system.

The study in Circulation 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) at some time from the beginning of 2006 to the end of 2010. Of the patients studied, 608 were treated with dronedarone, 2,984 patients with class Ic drugs, 2,065 patients with sotalol, and 2,905 patients were treated with amiodarone.

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

Dr. Allen LaPointe said the younger patient population “requires additional investigation” to better understand the effects of various anti-arrhythmic drugs in younger Afib patients, according to MedPage Today. Allen LaPointe said researchers and clinicians “don’t know if we should be treating these patients differently from older patients.”

Read more: Dronedarone Side Effects May Be Linked To Liver Failure Lawsuits