6-MONTH EFFECTS OF EARLY TREATMENT WITH LISINOPRIL AND TRANSDERMAL GLYCERYL TRINITRATE SINGLY AND TOGETHER WITHDRAWN 6 WEEKS AFTER ACUTE MYOCARDIAL-INFARCTION - THE GISSI-3 TRIAL

Objectives. This 6-month follow-up analysis sought to assess whether t he early reduction of mortality obtained with a 6-week treatment cours e of lisinopril or glyceryl trinitrate, or both, in unselected patient s with acute myocardial infarction outlasts therapy and is still prese nt after 6 months. The primary outcome of the 6-month follow up was th e combined end point of mortality and severe left ventricular dysfunct ion. Background. The assumption was that the early benefit on remodeli ng processes may be maintained over a longer period of time, even in t he absence of treatment. Methods. A total of 19,394 patients with acut e myocardial infarction were randomized, within 24 h of onset of sympt oms to a 6-week treatment course of oral lisinopril or open control an d, according to a 2 x 2 factorial design, to glyceryl trinitrate or op en control. Randomized treatments were stopped after 6 weeks in the ab sence of specific indications, and the patients were followed up for 6 months. Results. At 6 months, among patients randomized to lisinopril , 18.1% died or developed severe ventricular dysfunction versus 19.3% of those randomized to no lisinopril (2p = 0.03). No difference was fo und between patients with and without glyceryl trinitrate therapy (18. 4% vs, 18.9%, 2p = 0.39). Conclusions. Although the systematic adminis tration of glyceryl trinitrate started early and continued for 6 weeks after acute myocardial infarction does not yield evidence of benefit, early treatment with lisinopril appears to improve prognosis. This ef fect seems to carry over the first 6 months from randomization, even a fter treatment withdrawal.