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| |  Use Of Toprol-XL Improved Survival In Heart Failure Trial WAYNE, PA -- June 11, 1999 -- Adding AstraZeneca PLC’s beta-blocker Toprol-XL(R) (metoprolol succinate extended release) to standard treatment in patients with congestive heart failure reduced the overall death rate by 34 percent, according to results of the Metoprolol CR/XL (Controlled Release) Randomized Intervention Trial in Heart Failure (MERIT-HF), the largest heart failure trial ever completed evaluating the efficacy of a beta-blocker. The MERIT-HF study also found a 41 percent reduction in sudden deaths (patients who died suddenly from heart attacks) and a 49 percent reduction in heart failure deaths (patients who eventually died from heart attacks) among patients treated with Toprol-XL. Results of MERIT-HF are published in the current issue of The Lancet. The MERIT-HF Study is the first trial of beta blockade to include 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 classes II, III and IV. In MERIT-HF, almost 4,000 patients in 14 countries with moderate-to-severe heart failure were randomised 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 1,000 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. Other outcome measures such as hospitalisations, quality of life and health economics were also measured. Full analysis of this data is presently under way. 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, due to the significant reduction in mortality in those patients on Toprol-XL found on a scheduled interim analysis by the independent safety monitoring committee. 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 current 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 hospitalisations 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 US annually. Metoprolol CR/XL (marketed in the U.S. as Toprol-XL) is the most widely prescribed beta-blocker in the world. In the U.S., Toprol-XL 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. "The search for an effective medication that can reduce mortality in patients with heart failure, over and above standard therapy, is becoming increasingly important as the incidence of the disease continues to rise," said Stephen Gottlieb, MD, associate professor of medicine at the University of Maryland School of Medicine and co-chairman of the executive committee of MERIT-HF. "We are encouraged by the results of MERIT-HF because the significant 34 percent reduction in all-cause mortality observed adds to the growing body of evidence of the benefits of using beta-blockade in heart failure."
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