A randomized placebo-controlled trial to assess the efficacy of antiinflammatory therapy with methylprednisolone in unstable angina (MUNA trial).

Abstract

The purpose of this study was to assess the efficacy of antiinflammatory therapy with methylprednisolone during the acute phase of unstable angina. This is a randomized 'prospective' double-blind, placebo-controlled trial. Patients with the diagnosis of unstable angina were randomized to a 48-h course of methylprednisolone (n=81) or placebo (n=85). Patient care and therapy were otherwise decided by their attending cardiologist. The primary end-point was a composite of in-hospital recurrence of angina, silent ischaemia on Holter recording, emergency coronary revascularization, readmission with unstable angina, and myocardial infarction or death during the 30-day follow-up. The two groups were well balanced and had similar clinical characteristics at baseline. Forty-eight hours after randomization, mean C-reactive protein levels decreased by 2.6 mg. l(-1)in the methylprednisolone group, but increased by 1.6 mg. l(-1)in the placebo group (P=0.03). The primary end-point occurred in 44% of the methylprednisolone patients and in 33% of the placebo patients (P=0.12). Coronary revascularization rates were equal between the two groups (38% and 40%). When adjustment was made for the difference in revascularization times, a trend towards better event-free survival was seen in the control group (67% vs 57%;P=0.09). A 48 h course of antiinflammatory therapy with methylprednisolone given at the doses of this study did not improve the short-term outcome of patients with unstable angina.