ASPEN study

Introduction

Multinational, industry-sponsored, randomized trial

2410 patients with diabetes mellitus type 2

all patients with LDL cholesterol < 160 mg/dL,

those with coronary artery disease (CAD), LDL cholesterol < 140 mg/dL

Treatment groups:

• atorvastatin 10 mg QD
• placebo

Median follow-up of 4 years

Results:

• second 1/2 of study discontinued when for patients with coronary artery disease when NCEP issued new guidelines & lowered LDL targets
• mean LDL reduction of 29% in atorvastatin group
• no significant differences in cardiovascular events (myocardial infarction, stroke) between groups
• atorvastatin lowered risk for myocardial infarction by 19% in patients without history of CAD & by 36% in patients with CAD, but the differences were not statistically significant

More general terms

• clinical trial