Effect of fluvastatin on ischaemia following acute myocardial infarction:a randomized trial

Abstract

Alms Residual ischaemia following acute myocardial infarction (AMI) is related to an adverse outcome, although the effect of early initiation of statin therapy is unknown. Methods A randomized, placebo-controlled, double-blind, parallel study was performed, which compared fluvastatin 80 mg daily with placebo in patients with an AMI and total cholesterol of <6(.)5 mmol . 1(-1). Ischaemia was measured by ambulatory electrocardiographic (AECG) monitoring over 48-h at baseline, after 6 weeks and at 12 months. Results Five hundred and forty patients were included (83% male, age 61 +/- 11 years); 43% had an anterior AMI and 50% were treated with fibrinolytics in the acute phase. After 12 months, the total cholesterol (TC) level was reduced by 13% and LDL-C (low-density-lipoprotein cholesterol) by 21% (from 3(.)5 mmol . 1(-1) to 2-7 mmol . 1(-1)) in the fluvastatin treatment group. Both TC and LDL increased by 9% in the placebo group (P Conclusion Residual ischaemia after AMI is observed less frequently in the present study, than in earlier studies, although it is predictive for future cardiovascular events. As a result, the present study was underpowered, and no effect of fluvastatin on AECG ischaemia, or major clinical events in the first year after AMI, could be detected. The present data do not confirm other reports which support widespread use of statin treatment early after AMI. (C) 2002 The European Society of Cardiology. Published by Elsevier Science Ltd. All rights reserved