Data evaluates rehospitalization and cost burden of AFib/atrial flutter

Two studies to be presented this week address the often-overlooked costs associated with atrial fibrillation (AFib), the most common form of cardiac arrhythmia. Each study evaluates these costs and updates a growing body of evidence suggesting that the true costs of AFib are complex and may not yet be fully understood. The patient populations studied mimic those in the landmark ATHENA trial, a placebo-controlled, double-blind, parallel arm trial to assess the safety and efficacy of dronedarone 400 mg bid for the prevention of cardiovascular hospitalization or death from any cause in patients with atrial fibrillation/atrial flutter.

Dronedarone is an antiarrhythmic drug indicated to reduce the risk of cardiovascular hospitalization in patients with paroxysmal or persistent atrial fibrillation (AFib) or atrial flutter (AFL), with a recent episode of AFib/AFL and associated cardiovascular risk factors (i.e., age >70, hypertension, diabetes, prior cerebrovascular accident, left atrial diameter ≥50 mm or left ventricular ejection fraction [LVEF] <40%), who are in sinus rhythm or who will be cardioverted.

Editorial support for development of this poster was funded by sanofi-aventis U.S. Inc.

Lead investigator, Alpesh N. Amin, MD, University of California, Irvine, is available to discuss key findings following each session.

WHERE:
HeartRhythm 2011

San Francisco, CA or via Teleconference

WHEN:
Thursday, May 5th, 9:00 AM PT

“Cost Burden to U.S. Payors of ATHENA-Like Patients with Atrial Fibrillation/Atrial Flutter” (poster presentation 11-A-5161-HRS)

Thursday, May 5th, 2:00 PM PT

“Rehospitalization Rates and Costs in Hospitalized ATHENA-Like U.S. Patients with Atrial Fibrillation/Atrial Flutter” (oral presentation 11-A-5148-HRS)

Atrial Fibrillation is the most common form of cardiac arrhythmia. It is associated with an increased risk for stroke , heart failure and death and its prevalence is expected to rise as the population ages In fact, as a growing population of Americans begins to reach their Medicare years, AFib — which disproportionately affects those over the age of 65 — has the potential to be a largely unrecognized cost-driver.

CONTACT:
Tom Murphy on behalf of sanofi-aventis, U.S.

202-609-6005

tmurphy@ccapr.com

About the study authors:

Dr. Amin has received funding for research and speaking from sanofi-aventis U.S. Inc. Dr. Mehul Jhaveri is an employee of sanofi-aventis U.S. Inc. Dr. Jay Lin is an employee of Novosys Health, which has a research consulting agreement with sanofi-aventis U.S. Inc.

Important Safety Information for MULTAQ®

Contraindications

WARNING: HEART FAILURE

MULTAQ is contraindicated in patients with NYHA Class IV heart failure, or NYHA Class II — III heart failure with a recent decompensation requiring hospitalization or referral to a specialized heart failure clinic.

In a placebo-controlled study in patients with severe heart failure requiring recent hospitalization or referral to a specialized heart failure clinic for worsening symptoms (the ANDROMEDA Study), patients given MULTAQ had a greater than two-fold increase in mortality. Such patients should not be given MULTAQ.

MULTAQ is also contraindicated in patients with second- or third-degree atrioventricular (AV) block or sick sinus syndrome (except when used in conjunction with a functioning pacemaker), bradycardia <50 bpm, QTc Bazett interval ≥500 msec or PR interval >280 msec, and severe hepatic impairment.

MULTAQ should not be given to patients who are or may become pregnant (Category X) or nursing. MULTAQ may cause fetal harm when administered to a pregnant woman.

MULTAQ should not be coadministered with strong CYP 3A inhibitors, such as ketoconazole, itraconazole, voriconazole, cyclosporine, telithromycin, clarithromycin, nefazodone, ritonavir, or drugs or herbal products that prolong the QT interval and might increase the risk of Torsade de Pointes, such as phenothiazine antipsychotics, tricyclic antidepressants, certain macrolide antibiotics, and Class I and III antiarrhythmics.

New or Worsening Heart Failure

Postmarketing cases of new onset and worsening heart failure have been reported during treatment with MULTAQ. Advise patients to consult a physician if they develop signs and symptoms of heart failure, such as weight gain, dependent edema, or increasing shortness of breath. If heart failure develops or worsens, consider the suspension or discontinuation of MULTAQ.

Liver Injury

Hepatocellular liver injury, including acute liver failure requiring transplant, has been reported in patients treated with MULTAQ in the postmarketing setting. Advise patients treated with MULTAQ to report immediately symptoms suggesting hepatic injury (such as anorexia, nausea, vomiting, fever, malaise, fatigue, right upper quadrant pain, jaundice, dark urine, or itching). Consider obtaining periodic hepatic serum enzymes, especially during the first 6 months of treatment. It is not known whether routine periodic monitoring of serum enzymes will prevent the development of severe liver injury. If hepatic injury is suspected, promptly discontinue MULTAQ and test serum enzymes, aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase, as well as serum bilirubin, to establish whether there is liver injury. If liver injury is found, institute appropriate treatment and investigate the probable cause. Do not restart MULTAQ in patients without another explanation for the observed liver injury.

Hypokalemia and Hypomagnesemia with Potassium-Depleting Diuretics

Hypokalemia and hypomagnesemia may occur with concomitant administration of potassium-depleting diuretics. Potassium levels should be within the normal range prior to administration of MULTAQ and maintained in the normal range during administration of MULTAQ.

QT Interval Prolongation

MULTAQ induces a moderate (average of about 10 msec but much greater effects have been observed) QTc (Bazett) prolongation. If the QTc Bazett interval is ≥500 msec, MULTAQ should be stopped.

Increase in Creatinine

Serum creatinine levels increase by about 0.1 mg/dL following MULTAQ treatment initiation. The elevation has a rapid onset, reaches a plateau after 7 days and is reversible after discontinuation. If an increase in serum creatinine occurs and plateaus, this increased value should be used as the patient’s new baseline. The change in creatinine levels has been shown to be the result of an inhibition of creatinine’s tubular secretion, with no effect upon the glomerular filtration rate.

Drug-Drug Interactions

Treatment with Class I or III antiarrhythmics or drugs that are strong inhibitors of CYP 3A must be stopped before starting MULTAQ (see Contraindications). Patients should be instructed to avoid grapefruit juice beverages while taking MULTAQ. Calcium channel blockers and beta-blockers could potentiate the effects of MULTAQ on conduction. Increased digoxin levels and gastrointestinal disorders have been observed when MULTAQ was coadministered with digoxin. Digoxin can also potentiate the electrophysiologic effects of MULTAQ (such as decreased AV-node conduction); the need for digoxin therapy should be reconsidered when prescribing MULTAQ. If digoxin treatment is continued, halve the dose of digoxin, monitor serum levels closely, and observe for toxicity. Postmarketing cases of increased INR with or without bleeding events have been reported in warfarin-treated patients initiated with MULTAQ. Monitor INR after initiating MULTAQ in patients taking warfarin.

Adverse Reactions

In studies, the most common adverse reactions observed with MULTAQ were diarrhea, nausea, abdominal pain, vomiting, and asthenia.

Please see full prescribing information, including BOXED WARNING at http://products.sanofi-aventis.us/multaq/multaq.html.

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