To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Toprol-XL (Metoprolol) Extended Release Available In US For Heart Failure URL: http://www.pslgroup.com/dg/1F6DF6.htm Doctor's Guide April 3, 2001
WAYNE, PA -- April 3, 2001 -- AstraZeneca announced availability of the 25-mg extended-release tablets of Toprol-XL® (metoprolol succinate) for the treatment of stable, symptomatic (NYHA* Class II or III) heart failure of ischemic, hypertensive, or cardiomyopathic origin. Based on the results of a landmark clinical trial, Toprol-XL received U.S. Food and Drug Administration (FDA) approval on February 5, 2001. The new heart failure indication is in addition to the use of Toprol-XL in treating hypertension and angina pectoris. Toprol-XL is the most widely prescribed branded beta-blocker in the U.S. The new low-dose, scored 25-mg tablet is in addition to the 50-mg, 100-mg and 200-mg dividable tablets. The recommended starting dose of Toprol-XL in heart failure is 25-mg once-daily for two weeks in patients with NYHA class II heart failure and 12.5-mg once-daily in patients with more severe heart failure. If this dosage is tolerated, it may be doubled every two weeks to the highest dosage level tolerated by the patient or up to 200-mg. Toprol-XL is contraindicated in severe bradycardia, heart block greater than first degree, cardiogenic shock, decompensated cardiac failure and sick sinus syndrome (unless a permanent pacemaker is in place). Patients taking Toprol-XL should avoid abrupt cessation of therapy. Following abrupt cessation of therapy with certain beta-blocking agents, exacerbations of angina pectoris and, in some cases, myocardial infarction have occurred. The dosage should be reduced gradually over a one- to two-week period while monitoring patients. In the Metoprolol CR/XL (Controlled Release) Randomized Intervention Trial in Heart Failure (MERIT-HF) comparing Toprol-XL to placebo in daily doses up to 200-mg once daily, 10.3 percent of Toprol-XL patients discontinued due to adverse events verses 12.2 percent of placebo patients. The most frequent adverse events that occurred at an incidence of equal to or more than one percent and greater than placebo by more than 0.5 percent were dizziness/vertigo (1.8 percent vs. 1.0 percent placebo), bradycardia (1.5 percent vs. 0.4 percent placebo) and accident and/or injury (1.4 percent vs. 0.8 percent placebo). There is a risk of worsening cardiac failure during up-titration of the dose of Toprol-XL. Patients need to consult their physicians if they experience signs or symptoms of worsening heart failure such as weight gain or increasing shortness of breath. Congestive heart failure is a condition in which the heart fails to pump blood normally. As a result, functions of many organs in the body are disturbed and symptoms such as fatigue and breathlessness develop. The most frequent underlying causes of heart failure are previous heart attack and high blood pressure. The incidence of heart failure continues to increase, in part, due to an aging population. In the U.S., approximately four-to-five million people have heart failure, with 550,000 new cases occurring each year. Heart failure results in almost one million hospitalizations each year and is the most common hospital discharge diagnosis in patients 65 years and older. It is the only major cardiovascular disorder that is increasing in incidence and prevalence. The impact of Toprol-XL on these statistics has not been determined. * Classification of heart failure is commonly based on the New York Heart Association (NYHA) classification of heart failure. There are four functional classes in the NYHA scheme: -- Class I: No limitation: ordinary physical exercise does not cause undue fatigue, dyspnea, or palpitations -- Class II: Slight limitation of physical activity: comfortable at rest but ordinary activity results in fatigue, palpitations or dyspnea (shortness of breath, particularly after exercise and when lying down) -- Class III: Marked limitation of physical activity: comfortable at rest but less than ordinary activity results in symptoms -- Class IV: Unable to carry out any physical activity without discomfort (symptoms of heart failure are present even at rest with increased discomfort with any physical activity) SOURCE: AstraZeneca LP --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. 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