AstraZeneca Launches Toprol-XL(R) (metoprolol succinate) for Treating Heart Failure

New 25-mg Extended-Release Tablet Now Available



Apr 02, 2001, 01:00 ET from AstraZeneca LP

    WAYNE, Pa., April 2 /PRNewswire/ -- AstraZeneca (NYSE:   AZN) today
 announced availability of the  25-mg extended-release tablets of Toprol-XL(R)
 (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. For full prescribing information for Toprol-XL including
 boxed warning, call 1-800-236-9933 or visit http://www.astrazeneca-us.com.
     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% vs. 1.0% placebo), bradycardia  (1.5% vs. 0.4%
 placebo) and accident and/or injury (1.4% vs. 0.8% 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.
 
     About Congestive Heart Failure
     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.
 
     About AstraZeneca
     AstraZeneca (NYSE:   AZN) is a major international healthcare business
 engaged in the research, development, manufacture and marketing of ethical
 (prescription) pharmaceuticals and the supply of healthcare services.  It is
 one of the top five pharmaceutical companies in the world with healthcare
 sales of $15.8 billion and leading positions in sales of cardiovascular,
 gastrointestinal, oncology, anesthesia (including pain management), central
 nervous system (CNS) and respiratory products.  In the United States,
 AstraZeneca is an $8 billion healthcare business with more than 10,000
 employees.
     For more information about AstraZeneca please visit
 http://www.astrazeneca-us.com.
 
     *  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
    WAYNE, Pa., April 2 /PRNewswire/ -- AstraZeneca (NYSE:   AZN) today
 announced availability of the  25-mg extended-release tablets of Toprol-XL(R)
 (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. For full prescribing information for Toprol-XL including
 boxed warning, call 1-800-236-9933 or visit http://www.astrazeneca-us.com.
     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% vs. 1.0% placebo), bradycardia  (1.5% vs. 0.4%
 placebo) and accident and/or injury (1.4% vs. 0.8% 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.
 
     About Congestive Heart Failure
     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.
 
     About AstraZeneca
     AstraZeneca (NYSE:   AZN) is a major international healthcare business
 engaged in the research, development, manufacture and marketing of ethical
 (prescription) pharmaceuticals and the supply of healthcare services.  It is
 one of the top five pharmaceutical companies in the world with healthcare
 sales of $15.8 billion and leading positions in sales of cardiovascular,
 gastrointestinal, oncology, anesthesia (including pain management), central
 nervous system (CNS) and respiratory products.  In the United States,
 AstraZeneca is an $8 billion healthcare business with more than 10,000
 employees.
     For more information about AstraZeneca please visit
 http://www.astrazeneca-us.com.
 
     *  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