Consensus Ii

Several years ago, the Cooperative New Scandinavian Enalapril Survival Study II (CONSENSUS II) (98) had planned to randomize 9000 patients to determine whether early administration (within 24 h of the onset of symptoms of AMI) of iv enalapril would reduce mortality during a 6-mo follow-up period. Mortality at 6 mo did not differ significantly between groups (9.4% in the placebo group and 10% in the enalapril group, p = 0.26). However, the trial was terminated early, after approx 6000 patients were enrolled due to concerns of adverse effects from early hypotension. This side effect, defined as a systolic blood pressure <90 mmHg or diastolic blood pressure <50 mmHg, was observed more commonly in the treatment group than in the placebo group. Furthermore, patients with hypotension appeared to have a poorer clinical outcome. These findings led to an early and erroneous recommendation against the use of intravenous ACE inhibition in acute infarction, particularly when accompanied by thrombolytic therapy with streptokinase, which may itself lead to hypotension via similar enzymatic pathways.

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