Alirocumab in high-risk patients: Observations from the open-label expanded use program.

•The alirocumab expanded use program provided drug access before US approval.•Very high-risk hypercholesterolemic patients uncontrolled by therapy were enrolled.•Alirocumab reduced average low-density lipoprotein cholesterol from baseline 221 to 102 mg/dL at week 24 (55%).•Safety and efficacy observations were consistent with those in the ODYSSEY trials.