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STUDY IN 'THE NEW ENGLAND JOURNAL OF MEDICINE' DEMONSTRATES BENEFIT OF COMBINATION THERAPY FOR CONGESTIVE HEART FAILURE

 BOSTON, July 1 /PRNewswire/ -- A study published today in "The New England Journal of Medicine" found that patients with congestive heart failure who were treated with a three-drug regimen (Lanoxin(R) brand digoxin, a diuretic and an angiotensin converting enzyme ((ACE)) inhibitor) fared significantly better than those in whom digoxin was withdrawn from the regimen. In the study, known as RADIANCE, patients withdrawn from digoxin treatment were nearly six times more likely to experience a worsening in their condition -- in some cases severe enough to require emergency care or hospitalization -- than those who continued to receive the drug.
 "RADIANCE provides clear clinical evidence that digoxin therapy plays an important role in the management of heart failure," said Milton Packer, M.D., chairman of the study's steering committee and Dickinson W. Richards, Jr. professor of medicine and chief of the division of circulatory physiology at Columbia-Presbyterian Medical Center in New York City. "Based on the finding that withdrawal of digoxin carries considerable risks, including a deterioration in symptoms and quality of life, patient management should focus on use of triple therapy -- digoxin in combination with ACE inhibitors and d
 A recent survey of 100 primary care physicians found that only 17 percent of those queried would prescribe a combination of digoxin, diuretics and ACE inhibitors (known as triple therapy) for mild heart failure (New York Heart Association Class II), and only 31 percent would prescribe it for moderate heart failure (New York Heart Association Class III). Yet, RADIANCE demonstrated that patients with mild or moderate heart failure who were treated with triple therapy remained stable during the study period.
 Study Results
 RADIANCE, or Randomized Assessment of Digoxin on Inhibitors of the ANgiotensin Converting Enzyme, is the first large, randomized, double-blind, placebo-controlled, withdrawal study to evaluate the effects of digoxin in patients receiving diuretics and ACE inhibitor therapy. Begun in 1989 at 43 clinical sites, RADIANCE evaluated 178 patients with mild to moderate chronic heart failure.
 All patients were stabilized on digoxin, diuretics, and ACE inhibitor therapy for eight weeks. They were then randomized to continued therapy with digoxin (85 patients) or withdrawal from digoxin and replacement with placebo (93 patients) for another 12 weeks. Other medical therapy for heart failure remained constant. During the 12-week, double-blind study period:
 -- Patients not receiving digoxin treatment experienced a
 deterioration in all measures of functional capacity:
 -- maximal exercise tolerance (the amount of time exercising on
 a treadmill)
 -- exercise endurance (the distance walked in six minutes)
 -- New York Heart Association class (a measure of the patient's
 functional status and symptoms)
 -- Quality-of-life scores deteriorated more frequently and improved
 less frequently in patients not receiving digoxin treatment than
 in those receiving the drug
 -- More patients withdrawn from digoxin experienced a deterioration
 in their condition requiring intervention than patients receiving
 digoxin (23 vs. 4)
 -- More patients withdrawn from digoxin required emergency room care
 or hospitalization than patients receiving digoxin (12 vs. 2)
 -- Study participants who were not receiving digoxin had a decrease
 in ejection fraction (a measure of the heart's pumping ability)
 and an increase in heart rate and body weight
 -- Adverse reactions serious enough to require discontinuation of
 therapy occurred in 37 percent of patients not receiving digoxin
 versus 14 percent of those continued on digoxin
 In addition to the health benefits, maintaining patients on digoxin may mean a savings in health care costs. According to Dr. Packer, "Patients withdrawn from digoxin had a higher risk of worsening heart failure requiring hospitalization, which is very costly." In contrast, he added, "The use of digoxin costs the patient only twelve cents a day."
 Digoxin Commonly Prescribed
 Digoxin, a pure, stable crystalline glycoside (a carbohydrate containing a sugar molecule) isolated from the leaves of the foxglove plant, has been used for 59 years for the treatment of heart failure. It was first marketed in 1934 by Burroughs Wellcome Co. and given the brand name Lanoxin in 1956.
 Each year, more that 3.5 million Americans take digoxin, making it the fourth most commonly prescribed drug in the United States. Digoxin is used primarily for the treatment of symptomatic heart failure, with or without arrhythmias (irregular heart rhythm). The drug improves the heart's pumping action and slows heart rate, thereby improving oxygen delivery to tissues. The overall incidence of adverse reactions associated with digoxin has been reported to be five to 20 percent, with 15 to 20 percent of those considered serious. The most common adverse events include disturbances in heart rhythm, gastrointestinal effects (e.g., loss of appetite, nausea, vomiting and diarrhea) and vision problems. Dizziness and other manifestations of central nervous system toxicity also have been reported.
 Burroughs Wellcome Co. is a research-based pharmaceutical company headquartered in Research Triangle Park, N.C. It is a wholly owned subsidiary of The Wellcome Foundation Ltd. (Wellcome plc), an international pharmaceutical company headquartered in London.
 -0- 7/1/93
 /EDITOR'S NOTE: Full prescribing information is available upon request/
 /CONTACT: Mari Toth or Doug Stokke of Burroughs Wellcome, 919-248-3000/


CO: Burroughs Wellcome Company ST: North Carolina IN: MTC HEA SU:

SB-DF -- CH004 -- 7532 07/01/93 08:33 EDT
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Date:Jul 1, 1993
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