Efficacy Assessment of Meloxicam, a Preferential Cyclooxygenase-2 Inhibitor, in Acute Coronary Syndromes Without ST-Segment Elevation. The Nonsteroidal Anti-Inflammatory Drugs in Unstable Angina Treatment-2 (NUT-2) Pilot Study - NUT-2

Description:

The goal of this study was to assess the safety and efficacy of the combination of Meloxicam with heparin and aspirin superior to heparin and aspirin alone among patients with Non-ST-elevation acute coronary syndrome

Study Design

Study Design:

Secondary Endpoints:

coronary revascularization procedures, MI and death

Drug/Procedures Used:

Patients with acute coronary syndromes without ST-segment elevation were randomized in open labeled fashion to aspirin and heparin treatment (n=60) or aspirin, heparin, and meloxicam (n=60) during coronary care unit stay followed by aspirin or aspirin plus meloxicam for 30 days.

Principal Findings:

The primary outcome (recurrent angina, myocardial infarction, or death) was significantly lower in the patients receiving meloxicam (15.0% vs. 38.3%, P=0.007) during the stay in coronary care unit. The secondary outcome (coronary revascularization procedures, myocardial infarction, and death) was also significantly lower in meloxicam-treated patients (10.0% vs. 26.7%, P=0.034). The beneficial effects of meloxicam on the primary (21.7% vs. 48.3%, P=0.004), as well as secondary (13.3% vs. 33.3%, P=0.015) end-points persisted at 90 days. Similarly, the need for revascularization alone was lower in meloxicam group at 90 days (11.7% vs. 30.0%, P=0.025). This benefit of meloxicam occurred without any increase in the risk of adverse side effects.

Interpretation:

Among patients with an acute coronary syndrome without ST segment elevation, a combination of meloxicam with heparin and aspirin was associated with significant reductions in adverse outcomes. Recurrent angina and the need for coronary revascularization (generally driven by recurrent symptoms) were the only end-points reduced among the composite primary and secondary end-points. While these prelimary data are provocative, there was no association with a reduction in hard endpoints such as death or recurrent MI. Larger randomized prospective trials are needed to confirm and and expand upon these preliminary findings.

References:

Altman R, Luciardi HL, Muntaner J, et al. Efficacy Assessment of Meloxicam, a Preferential Cyclooxygenase-2 Inhibitor, in Acute Coronary Syndromes Without ST-Segment Elevation. The Nonsteroidal Anti-Inflammatory Drugs in Unstable Angina Treatment-2 (NUT-2) Pilot Study. Circulation 2002; 106: 191-95.

Clinical Topics: Acute Coronary Syndromes, Anticoagulation Management, Anticoagulation Management and ACS

Keywords: Myocardial Infarction, Acute Coronary Syndrome, Platelet Aggregation Inhibitors, Cyclooxygenase Inhibitors, Coronary Care Units, Heparin, Thiazoles, Thiazines


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