Date of Award
Selective Evidence-Based Medicine Review
Master of Science in Health Sciences - Physician Assistant
Physician Assistant Studies
John Cavenagh, MBA, PhD, PA-C
Objective: The objective of this selective EBM review is to determine whether or not PCSK9 monoclonal antibodies plus SOC prevent major adverse cardiovascular events in adults with hypercholesterolemia compared to placebo plus SOC.
Study Design: This review is using one double-blinded randomized controlled trial (RCT) and two open-label RCTs investigating alirocumab and evolocumab, published in 2014 and 2015.
Data sources: Articles were found on PubMed, and were published in peer-reviewed journals in English.
Outcome Measured: The outcome measured was major adverse cardiac events (MACE), which included death, MI, hospitalization for unstable angina, revascularization, or cerebrovascular event.
Results: Robinson, et al. showed a lower incidence of MACE in the alirocumab group compared to the placebo group (p=0.02, CI 0.31-0.90) with a number needed to treat (NNT) of -62. Sabatine, et al. showed a lower incidence of MACE in the evolocumab group compared to SOC group (p=0.003, CI 0.28-0.78) with NNT of -93. Koren, et al. showed lower incidence of MACE in the evolocumab group compared to SOC with NNT of -105.
Conclusions: The results of the three studies indicate that PCSK9 monoclonal antibodies (alirocumab or evolocumab) prevented MACE when compared to placebo or SOC. More studies could investigate which of the two drugs has better efficacy to prevent MACE and safety. Further studies could be done to compare specific characteristics like those who are statinintolerant or those with familial hypercholesterolemia to patients already on a statin.
Doyle, Amy, "Do PCSK9 Monoclonal Antibodies plus SOC Prevent Major Adverse Cardiovascular Events in Adults with Hypercholesterolemia Compared to Placebo Plus SOC?" (2016). PCOM Physician Assistant Studies Student Scholarship. 398.