To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Toprol-XL Can Reduce Hospitalizations and Increase Survival In Heart Failure Patients URL: http://www.pslgroup.com/dg/143722.htm Doctor's Guide November 8, 1999
WAYNE, PA -- November 8, 1999 -- Adding the beta-blocker Toprol-XL(R) (metoprolol succinate) extended release tablets to standard treatment in patients with congestive heart failure participating in the Metoprolol CR/XL (Controlled Release) Randomized Intervention Trial in Heart Failure (Merit-HF) reduced all cause mortality and hospitalizations for heart failure by 31 percent. These new results of Merit-HF, the largest heart failure trial ever completed evaluating the efficacy of a beta-blocker, were presented at the American Heart Association's 72nd Scientific Sessions. A 32 percent decrease was also seen in the combined endpoint of death and the number of patients who had to undergo heart transplantation. Transplantation becomes necessary for survival when the heart has essentially lost its ability to effectively pump blood. "This is a major step in treating heart failure patients," said Dr. Stephen Gottlieb, associate professor of medicine at the University of Maryland School of Medicine and co-director of the U.S. executive committee of Merit-HF. "The Merit-HF findings showed that beta-blockade had a marked benefit on survival in heart failure patients. Reduced mortality and hospitalizations are significant because heart failure patients usually require frequent hospital stays to stabilize their disease. In Merit-HF, both the patients and the healthcare system benefited, because these typically extensive, expensive hospitalizations were cut by almost a third." Metoprolol CR/XL (marketed in the U.S. as Toprol-XL) is the most widely prescribed branded beta-blocker in the world. In the U.S., Toprol-XL is available in 50, 100 and 200 mg tablets and is indicated for hypertension and angina pectoris. It is not indicated for congestive heart failure. As with most beta-blocking agents, Toprol-XL is contraindicated in sinus bradycardia, heart block greater than first degree, cardiogenic shock, and overt cardiac failure. Patients with ischemic heart disease taking the medication should avoid abrupt cessation of therapy. In Merit-HF, almost 4000 patients with moderate-to-severe heart failure from 14 countries were randomized to once-daily doses of placebo or Toprol-XL, titrating from 12.5 mg or 25 mg to 200 mg per day over six weeks. In the U.S., more than 1000 patients participated. The main aim of the study was to investigate the impact of metoprolol succinate extended release compared with placebo on total mortality in patients with heart failure. Primary results showed a 34 percent reduction in overall death rate, a 41 percent reduction in sudden deaths and a 49 percent reduction in heart failure deaths. Merit-HF included significant numbers of patients across a wide spectrum of heart failure severity -- ranging from those who experience symptoms that slightly limit activity to those unable to carry out any physical activity without significant discomfort. The study found that the addition of Toprol-XL showed benefit in patients regardless of the severity of the disease, with similar response patterns for patients in New York Heart Association (NYHA) classes II, III and IV. There was a significant improvement in both NYHA class and also in self-rated quality of life among patients receiving Toprol-XL. Merit-HF was initiated in February 1997 and was expected to end in the year 2000. The study was stopped prematurely on October 31, 1998 at the recommendation of the Independent Safety Committee due to the significant reduction in mortality in patients randomized to Toprol-XL as compared to placebo. Chronic or congestive heart failure is a disease in which the heart fails to propel 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 chronic heart failure are previous heart attack and high blood pressure. The incidence of heart failure continues to increase, due to an aging population. Despite currently available treatments for heart failure, it is estimated that one-half of all patients diagnosed with heart failure will die within five years and one-half of those with severe heart failure will die within one year, a similar prognosis to cancer. In the U.S., approximately four-to-five million people have chronic heart failure with 400,000 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 economic impact of heart failure in the U.S. has been estimated to be as high as $40 billion annually. NOTE: 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, dyspnoea, or palpitations -- Class II: Slight limitation of physical activity: comfortable at rest but ordinary activity results in fatigue, palpitations or dyspnoea (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). --------------------------------------------------------------------------------------------- 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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