Merck’s Vasotec

Executive Summary

Heart failure indication is broadened to highlight increased survival in patients with symptomatic heart failure. Approved April 8, the indication states that among these patients, Vasotec, usually in combination with diuretics and digitalis, "improves symptoms, increases survival and decreases the frequency of hospitalization." Previous labeling indicated Vasotec (enalapril) as an "adjunctive therapy in the management of heart failure." A supplemental NDA was submitted in August 1991. Among data supporting the revised indication are results from the NIH's SOLVD Treatment Trial showing that Vasotec "significantly reduced deaths in all stages of symptomatic heart failure" ("The Pink Sheet, Nov. 18, 1991, T&G-8).