Healthcare Industry News: Reliant Pharmaceuticals
News Release - August 9, 2006
Use of Propafenone Hydrocloride Supported in New ACC/AHA/ESC Practice Guidelines for Managing Patients with Atrial FibrillationNew Treatment Algorithm Recommends Propafenone as First-Line Antiarrhythmic Therapy Option
- Atrial fibrillation (AF) is the most common sustained irregular heart rhythm disturbance
- ACC guidelines include new algorithms pointing to propafenone use before ablation and amiodarone for AF patients with no or minimal heart disease
"New ACC/AHA/ESC guidelines establish best-practice considerations for varied patient populations," said Robert Shalwitz, M.D., Vice President, Clinical Development, Reliant Pharmaceuticals Inc. "These guidelines are based on the latest evidence, including results from recent trials comparing rhythm control and rate control with long-term management of atrial fibrillation. RythmolŪ SR (propafenone hydrochloride) extended release is an effective treatment to help maintain sinus rhythm in patients with atrial fibrillation who require antiarrhythmic therapy and who are without structural heart disease. These guidelines point to Rythmol SR as an appropriate first-line antiarrhythmic treatment option within the revised treatment paradigm," he added.
The revised guidelines include pharmacologic intervention algorithms to assist clinicians in managing AF in different types of patients with varying degrees of structural heart disease. The algorithms provide a step-by-step process in order to determine clinical approaches to prevent, diagnose and manage AF.
AF is the most common sustained heart rhythm disturbance, which carries an increased long-term risk of stroke. Approximately 2.2 million people in the US are currently diagnosed with AF, and these numbers are projected to increase substantially during the next 20 years as the population ages. The annual risk of stroke in patients with AF is in the range of 3% to 8% per year, and one out of every six strokes occurs in a patient with AF. Rythmol SR was approved by the US Food and Drug Administration (FDA) in 2003 to prolong the time to recurrence of symptomatic AF in patients without structural heart disease.
Rythmol SR is indicated to prolong the time to recurrence of symptomatic atrial fibrillation in patients without structural heart disease. The use of Rythmol SR in patients with permanent atrial fibrillation or in patients exclusively with atrial flutter or PSVT has not been evaluated. Rythmol SR should not be used to control ventricular rate during atrial fibrillation.
The effect of Rythmol SR on mortality has not been determined. In the National Heart, Lung and Blood Institute's Cardiac Arrhythmia Suppression Trial (CAST), a long-term, multi-center, randomized, double-blind study in patients with asymptomatic non-life-threatening ventricular arrhythmias who had a myocardial infarction more than six days but less than two years previously, an increased rate of death or reversed cardiac arrest rate (7.7%; 56/730) was seen in patients treated with encainide or flecainide (Class 1C antiarrhythmics) compared with that seen in patients assigned to placebo (3.0%; 22/725). The average duration of treatment with encainide or flecainide in this study was ten months. The applicability of the CAST results to other populations (e.g., those without recent myocardial infarction) or other antiarrhythmic drugs is uncertain, but at present, it is prudent to consider any 1C antiarrhythmic to have a significant risk in patients with structural heart disease. Given the lack of any evidence that these drugs improve survival, antiarrhythmic agents should generally be avoided in patients with non-life-threatening ventricular arrhythmias, even if the patients are experiencing unpleasant, but not life-threatening, symptoms or signs.
Rythmol SR is contraindicated for patients with congestive heart failure (CHF), cardiogenic shock, marked hypotension, bradycardia, disturbances in cardiac impulse generation and/or conduction (atrioventricular or intraventricular blocks) in the absence of an artificial pacemaker, electrolyte imbalance, bronchospastic disorders, or hypersensitivity to the drug.
It is essential that each patient given Rythmol SR be evaluated electrocardiographically prior to and during therapy, to determine whether the response to Rythmol SR supports continued treatment.
Propafenone exerts a negative inotropic activity on the myocardium as well as beta-blockade effects and may provoke overt CHF.
Propafenone may alter both pacing and sensing thresholds of artificial pacemakers. Pacemakers should be monitored and programmed accordingly during therapy.
Patients with bronchospastic disease should not, in general, receive propafenone or other agents with beta-adrenergic-blocking activity.
Propafenone is highly metabolized by the liver and should, therefore, be administered cautiously to patients with impaired hepatic function.
Approximately 50% of propafenone metabolites are excreted in the urine following administration of Rythmol immediate-release tablets. Until further data are available, Rythmol SR should be administered cautiously to patients with impaired renal function.
Agranulocytosis (fever, chills, weakness, and neutropenia) has been reported in patients receiving propafenone. Unexplained fever and/or decrease in white cell count, particularly during the initial 3 months of therapy, warrant consideration of possible Agranulocytosis or granulocytopenia.
For information on drug interactions with Rythmol SR, see PRECAUTIONS: Drug Interactions section of full Prescribing Information.
Reliant Pharmaceuticals, Inc.
Reliant Pharmaceuticals is a pharmaceutical company with integrated sales, marketing and development expertise that markets a portfolio of branded cardiovascular pharmaceutical products. Reliant focuses on marketing promotionally sensitive pharmaceutical products to the high prescribing primary care, cardiovascular and specialist physician markets in the United States. Reliant also acquires rights to and develops product candidates in mid- to late-stage clinical development. Reliant's sales force infrastructure comprises approximately of 850 sales professionals nationwide.
Source: Reliant Pharmaceuticals
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