Alirocumab improves outcomes in patients with a history of recent acute coronary syndrome, but treatment acutely at the time of myocardial infarction is untested. We present the results of a randomized, placebo-controlled, double-blinded pilot study of alirocumab treatment at the time of non-ST elevation MI (NSTEMI). Twenty patients with type 1 NSTEMI and low-density lipoprotein cholesterol (LDL-C) >70 mg/dL despite high intensity statin therapy were randomized 1:1 to one dose of alirocumab 150 mg subcutaneously or placebo within 24 hours of presentation. LDL-C and inflammatory biomarkers—including C-reactive protein—were obtained at baseline, 72 hours, and 14 days. Median (interquartile range) and number (%) were: age 59 (49, 65) years, 7 (35%) men, 16 (80%) black; baseline characteristics were similar between groups. Alirocumab significantly reduced LDL-C from baseline to 14 days by 64 mg/dL (−96, −47) compared with placebo [+1 mg/dL (−25, +16)] (primary endpoint). There were no significant between-group differences in C-reactive protein changes at any time point (all P > 0.2) or serious adverse events attributable to the study treatment. In conclusion, alirocumab administration at the time of NSTEMI significantly reduced LDL-C levels at 14 days, was safe, and had neutral effects on inflammatory biomarkers. Further studies are warranted to explore the effects on clinical outcomes.
*Division of Cardiology, VCU Pauley Heart Center, Virginia Commonwealth University, Richmond, VA;
†Department of Pharmacotherapy and Outcomes Science, School of Pharmacy, Virginia Commonwealth University, Richmond, VA; and
‡Department of Pharmacy Services, Brigham and Women's Hospital, Boston, MA.
Reprints: Cory Trankle, MD, VCU Pauley Heart Center, Virginia Commonwealth University, PO Box 980053, 1200 E Marshall St, Richmond, VA 23298 (e-mail: email@example.com).
The study was funded by an investigator-initiated grant from Regeneron/Sanofi. Regeneron laboratory services performed the PCSK9 level analysis, but otherwise, neither company had a role in the study design, conduct, analysis, or reporting. It was also supported by a Clinical and Translational Science Award (UL1TR000058 from the National Center for Research Resources) to the Virginia Commonwealth University Center for Clinical and Translational Research. ClinicalTrials.gov Identification Number: NCT02938949.
The authors report no other conflicts of interest.
Received February 20, 2019
Accepted May 26, 2019