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BRISTOL-MYERS SQUlBB’s CAPOTEN APPROVED FOR LEFT VENTRICULAR DYSFUNCTION

Executive Summary

BRISTOL-MYERS SQUlBB's CAPOTEN APPROVED FOR LEFT VENTRICULAR DYSFUNCTION following a heart attack. The supplemental NDA (18- 343/S-048) for the angiotensin-converting enzyme inhibitor was approved Sept. 23 almost five years after it was originally submitted. The application was initially filed in December 1988 and resubmitted in May 1992. Adding to its indications for hypertension and heart failure, Capoten (captopril) is now also indicated "to improve survival following myocardial infarction in clinically stable patients with left ventricular dysfunction manifested as an ejection fraction </= 40%." Labeling adds that the drug can be used "to reduce the incidence of overt heart failure and subsequent hospitalizations for congestive heart failure in these patients." The approval is based on data from the Survival and Ventricular Enlargement (SAVE) trial conducted in over 2,000 patients who had survived acute myocardial infarctions. In the trial, captopril reduced risk for all-cause mortality by 19% and cardiovascular death by 21%, and 22% fewer patients receiving captopril had overt symptoms of heart failure than placebo-treated patients. The data were reviewed by FDA's Cardiovascular & Renal Drugs Advisory Committee in February, leading to a unanimous approval recommendation ("The Pink Sheet" Feb. 22, p. 19). The committee decided in a five-to-four vote that the reduction of recurrent MI should not be mentioned in the new captopril labeling because a statistically significant benefit was shown only after a retrospective change in definition of MI. The recommended initial dose of captopril for post-Ml patients is the same as that used in the SAVE trial, a single test dose of 6.25 mg followed by 12.5 mg t.i.d., which is then increased to 25 mg t.i.d after several days. Labeling recommends a target maintenance dose of 50 mg t.i.d. to be achieved over several weeks.
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