Background: There is controversy about whether lipid-lowering pharmacotherapy should be initiated immediately after an acute coronary event or only after diet and lifestyle changes have proved inadequate.
Objective: This study, known as the Lipid Intervention Strategies for Coronary Patients Study, compared the efficacy of immediate versus deferred simvastatin treatment in conjunction with dietary advice about reducing lipid levels in hypercholesterolemic patients with acute coronary syndromes.
Methods: This randomized, open-label, parallel-group study included 151 hypercholesterolemic (low-density lipoprotein cholesterol [LDL-C] >3.0 mmol/L) men and women aged 35 to 75 years. Within 4 days of diagnosis of acute myocardial infarction (MI) or unstable angina pectoris, all patients received dietary advice from a specially trained nurse. Subsequently, patients were randomized to 2 treatment groups: 1 group received immediate treatment with simvastatin 40 mg/d; patients in the other group received simvastatin 40 mg/d after 3 months only if their LDL-C remained >3.0 mmol/L.
Results: The immediate-simvastatin group (n = 73) and the deferred-simvastatin group (n = 78) were balanced with respect to baseline characteristics. Of the 151 patients, 25% were women, 25% had concomitant hypertension, and 75% had a diagnosis of MI on enrollment. At 3 months, 90% of the patients receiving dietary advice plus immediate simvastatin treatment had achieved the recommended European target LDL-C level of <3.0 mmol/L, compared with 7% of those treated with diet alone. By 6 months, when 92% of the study participants were receiving simvastatin 40 mg/d, the proportion of patients achieving target LDL-C levels was 92% in the group that received immediate simvastatin therapy and 81% in the group that received deferred simvastatin therapy. The reductions in LDL-C (42%-48%) were considered to be clinically comparable between the 2 groups at 12 months.
Conclusions: On the basis of these results, we concluded that few patients with hypercholesterolemia and acute coronary syndromes reach the recommended European target LDL-C level of <3.0 mmol/L with dietary advice alone. However, early treatment with simvastatin 40 mg/d combined with dietary advice and follow-up at a dedicated outpatient clinic specializing in coronary heart disease resulted in 9 out of 10 patients reaching a recommended target LDL-C level of <3.0 mmol/L. Initiation of simvastatin therapy while a patient is hospitalized may increase the likelihood of the patient's lipid levels being managed according to current recommendations after he or she is discharged.