American Heart Association, 2006 Scientific Sessions: Dronedarone Maintains Sinus Rhythm in Atrial Fibrillation After Unsuccessful Previous Therapy

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Speaker: Bramah N. Singh, MD, Professor of Medicine, Cardiology Division, Department of Medicine, University of California, Los Angeles David Geffen School of Medicine, Los Angeles, California

Dronedarone (Multaq, Sanofi-Aventis), was found to be a viable treatment option for patients with atrial fibrillation (AF) after other antiarrhythmic drugs had exhibited poor efficacy in maintaining sinus rhythm. Dronedarone is a novel multichannel blocking antiarrhythmic agent that is structurally related to amiodarone grug (e.g., Pacerone, Upsher-Smith; Corda-rone, Wyeth-Ayerst).

A post hoc analysis of two phase 3 efficacy trials was performed:

•  the EURopean trial In atrial fibrillation or flutter patients receiving Dronedarone for the maintenance of Sinus rhythm) (EURIDIS)

•  the American-Australian-African trial with DronedarONe in atrial fibrillation or flutter patients for the maintenance of Sinus rhythm (ADONIS)

The analysis was undertaken to evaluate the efficacy of dronedarone in reducing recurrences of AF in patients who had taken at least one antiarrhythmic agent before randomization and who had discontinued the study because of the lack of that agent’s efficacy.

In the EURIDIS and ADONIS trials, 1,237 patients were randomly assigned, in a 2:1 fashion, to receive either dronedarone 400 mg twice daily (n = 828) or placebo (n = 409) in an outpatient setting. The patients were followed for 12 months.

The primary endpoints in both studies were the times to the first documented AF recurrences, as detected by electro-cardiography (ECG) or trans-telephonic ECG monitoring. A Cox regression model was used to determine the efficacy of dronedarone in patients whose previous treatment with class 1A, 1C, or III antiarrhythmic agents or sotalol (Betapace, Berlex) had failed.
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Overall, dronedarone lowered the risk of a first recurrence of AF by 25% (P = .0001), compared with placebo. For the primary endpoints of the two studies, the median time to first AF recurrence was 116 days with dronedarone and 53 days with placebo.

Dronedarone showed superior efficacy to placebo in all four subgroups (class 1A, class 1C, class III, and sotalol). Adverse events in each subgroup were in line with the consistently favorable overall EURIDIS and ADONIS trial results.

Torcetrapib/Atorvastatin Offers Improved Efficacy in Heterozygous Familial Hypercholesterolemia

Speaker: James H. Revkin, MD, Director, Cardiovascular and Metabolic Disease, Pfizer Global Research and Development, New London, Connecticut and Associate Clinical Professor of Medicine and Attending Physician, Yale Transplant Program, Section of Cardiovascular Medicine, Yale University, New Haven, Connecticut

Note to readers: Please see the Editor’s Note at the end of this topic about clinical trials with torcetrapib.

Torcetrapib/atorvastatin drug, a novel investigational drug combination, produced substantial elevations in high-density lipoprotein-cholesterol (HDL-C) and marked reductions in low-density lipoprotein cholesterol (LDL-C), compared with atorvastatin (Lipitor generic, Pfizer) alone in patients with heterozygous familial hypercholesterolemia (HeFH). Torcetrapib, a cholesterol ester transfer protein inhibitor, raises HDL-C levels. Canadian Atorvastatin, a statin drug, significantly reduces LDL-C levels.