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| |  AHA SCIENTIFIC SESSIONS: Metoprolol CR/XL Improves Survival In Heart Failure Patients DALLAS, TX -- Nov. 11, 1998 -- Adding Astra Pharmaceuticals, L.P.’s beta blocker Toprol-XL(R) (metoprolol succinate extended release) to standard treatment in patients with congestive heart failure can help reduce all-cause mortality and improve survival by about 35 percent. These are the preliminary 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. Results of MERIT-HF were announced today at the 71st scientific sessions of the American Heart Association. 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 metoprolol 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 survival in patients with heart failure; other outcome measures such as reduction in 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 large beneficial effect of metoprolol CR/XL found on a scheduled interim analysis by the independent safety monitoring committee. The incidence of heart failure continues to increase, due to an aging population. Despite current effective treatments for heart failure, it is estimated that one half of all patients diagnosed with heart failure will die in the next 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 new cases occurring each year. Heart failure results in almost one million hospitalisations each year and is the most common discharge diagnosis in patients 65 years and older. The economic impact of heart failure in the U.S. has been estimated to be as high as $38 billion US annually. "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 Sidney Goldstein, M.D., co-chairman of the executive committee of MERIT-HF. “The significant 35 percent reduction in mortality associated with metoprolol CR/XL is important because it adds to the growing body of evidence of the benefits of using beta blockers in heart failure." Metoprolol CR/XL (marketed in the U.S. as Toprol-XL(R)) is the most widely prescribed beta blocker in the world. In the U.S., Toprol-XL is indicated for hypertension and angina pectoris. 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 taking the medication should avoid abrupt cessation of therapy.
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