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ACE INHIBITOR USE CAN BE "JUSTIFIED" BY SOLVD TRIAL RESULTS

Executive Summary

ACE INHIBITOR USE CAN BE "JUSTIFIED" BY SOLVD TRIAL RESULTS in patients with asymptomatic left ventricular dysfunction, but the findings of the study are not clear enough to require ACE inhibitor use as standard treatment, one of the SOLVD trial investigators, Jay Cohn, MD, University of Minnesota, writes in an editorial in the Sept. 1 issue of The New England Journal of Medicine (see preceding T&G). "In the absence of clear survival benefit, the SOLVD [Studies of Left Ventricular Dysfunction] can justify but not require" use of ACE inhibitors as standard therapy in patients with asymptomatic left ventricular dysfunction. However, he noted, the SOLVD trial "at a minimum...has justified the use of enalapril to prevent mildly symptomatic patients with left ventricular dysfunction from getting worse." In addition, Cohn "strongly encouraged" physicians "to use an ACE inhibitor in patients with left ventricular dysfunction who are recovering from a myocardial infarction." He pointed out that beta blockers already have been shown to be effective in this population and that the SAVE (Survival and Ventricular Enlargement) trial results "suggest that ACE inhibitors may have an added benefit." Merck's Vasotec (enalapril) was used in the SOLVD trial while Bristol-Myers Squibb's Capoten (captopril) was studied in the SAVE trial. Cohn pointed out that since both the SAVE and SOLVD trials showed that ACE inhibitors can reduce the incidence of overt heart failure in patients with asymptomatic left ventricular dysfunction, "it might be argued that prophylactic therapy with these drugs saves medical costs." However, he noted that "all patients in the studies had evidence of ventricular systolic dysfunction at base line and were therefore likely to have congestive heart failure eventually." He suggested that the "primary benefit" of ACE inhibitor treatment "may be to delay, not to prevent, the costs associated with symptomatic congestive heart failure." "The prolongation of life demonstrated in the SAVE trial may well increase, not decrease, overall health care expenditures," Cohn observed. Regarding the CONSENSUS II (Cooperative New Scandinavian Enalapril Survival Study II) results, Cohn suggested that the higher death rate in the enalapril group "may lie in the design of the trial and the potentially adverse effect of early treatment with powerful vasodilator drugs." He pointed out that the SAVE and SOLVD investigators looked solely at patients with diagnosed left ventricular dysfunction and followed those patients for at least a year before the survival benefit became apparent. He predicted that early ACE inhibitor treatment could still be beneficial to an as yet unidentified subgroup that is "most likely to progress to left ventricular dilation." Cohn also pointed to the relatively high doses used in the three ACE inhibitor trials and recommended that physicians increase doses gradually to the levels used in the trials (Capoten 50 mg t.i.d. and Vasotec 20 mg daily) assuming patients tolerate the higher doses. "There has been an unfortunate trend among physicians to use drugs in doses below those recommended," Cohn states. "Nowhere is this trend more apparent than in the clinical use of ACE inhibitors, which are often prescribed in very low doses."
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