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Executive Summary

SQUIBB AND MERCK SEEKING EXPANDED USE OF ACEs IN POST-MI treatment and prevention of left ventricular dysfunction and enlarged heart. The new direction of ACE inhibitor research into the potentially large post-MI patient population is an outgrowth of the two companies' work in congestive heart failure. Squibb and Merck separately highlighted post-myocardial infarction studies of their respective ACE inhibitors on July 14. Squibb issued a statement on July 14 in response to a New England Journal of Medicine article on the use of Capoten in preventing progressive enlargement of the heart after a heart attack. The NEJM study, conducted by researchers at Boston's Brigham and Women's Hospital, found that "after anterior myocardial infarction, ventricular enlargement is progressive and that captopril may attenuate this process, reduce filling pressures, and improve exercise tolerance." The double-blind, placebo controlled study of 59 patients with a first anterior myocardial infarction and radionuclide ejection fraction of 45% or less included cardiac catheterization 11-31 days after the MI and another catheterization a year later. Results after catheterization of the 52 patients that completed the trial (25 on placebo and 27 on captopril) showed placebo patients "had no significant change in left ventricular end-diastolic pressure or pulmonary capillary wedge pressure" while patients on captopril "had a reduction in filling pressure" with significant decreases in both measurements. Captopril patients also showed improved exercise tolerance compared to the placebo group. In a subgroup of 36 high-risk patients, the researchers concluded that "ventricular dilatation was significantly attenuated by captopril treatment." These preliminary results, the investigators noted, "provide a rationale for further evaluation of this therapy in asymptomatic patients with left ventricular dysfunction who have had an infarction." The Brigham and Women's Hospital researchers are the lead investigators in the 43-center SAVE (Survival and Ventricular Enlargement) study that plans to evaluate approximately 2,200 patients for survival and prevention of congestive heart failure. At a press conference announcing FDA's recent approval of Vasotec (enalapril) as adjunctive therapy for congestive heart failure ("The Pink Sheet" July 4, T&G 2), enalapril researchers noted a two-year study with the Merck ACE at NIH for a similar use. The National Heart, Lung, and Blood Institute is funding a $ 33.5 mil. study with Vasotec called the SOLVD (Study of Left Ventricular Dysfunction) trial. The 23-center, 7,000 patient study includes two patient arms: 2,500 symptomatic patients and 4,500 asymptomatic patients. The two-year study, which is now approaching full enrollment, is looking at survival rates and improved left ventricular function. Recruitment of patients for the trial began in July 1986, and the study is targeted for completion in the first half of 1991.

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