PCSK9 Inhibitors: The Facts At-a-Glance

October 28, 2015
Veronica Hackethal, MD
Veronica Hackethal, MD

The 2 novel antihyperlipidemic drugs could change the face of CVD management and prevention. Get the basics on both offered in these slides.

FDA approval of the first-in-class PCSK9 inhibitors evolocumab and alirocumab in summer 2015 was met with a full spectrum of response, from elation among advocates for patients with variants of familial hypercholesterolemia to grave reservations among scientists who feel that LDL cholesterol level is not a reliable surrogate for cardiovascular benefit. Results are remarkable -- a dose-dependent reduction in LDL-C (up to 70%) occurred at between 4 and 14 days with a 2 to 8+ week delay in return to baseline with each agent.Whether you agree or disagree with the FDA decision, understanding the PCSK9 antibodies and how they work is worth the time it will take to view the short primer we offer in the slides above.     .


1. Rubenfire M. PCSK9 Inhibitors in the Cardiovascular Field: Ten Points to Remember.  American College of Cardiology website. Accessed October 22 2015 at: https://www.acc.org/latest-in-cardiology/ten-points-to-remember/2015/06/15/15/32/are-pcsk9-inhibitors-the-next-breakthrough-in-the-cardiovascular#sthash.JU5K6LTU.pdf

2. Praluent [package insert]. Accessed October 22 2015 at: http://products.sanofi.us/praluent/praluent.pdf

3. Repatha [package insert]. Accessed October 22 2015 at: http://pi.amgen.com/united_states/repatha/repatha_pi_hcp_english.pdf 

4. Everett BM, Smith RJ, Hiatt WR. Reducing LDL with PCSK9 Inhibitors - The Clinical Benefit of Lipid Drugs. N Engl J Med. 2015;373:1588-1591. DOI: 10.1056/NEJMp1508120

5. Navarese EP, Kolodziejczak M, Schulze V, et al. Effects of proprotein convertase subtilisin/kexin type 9 antibodies in adults with hypercholesterolemia: A systematic review and meta-analysis. Ann Intern Med. 2015;163:40-51. doi: 10.7326/M14-2957. http://www.ncbi.nlm.nih.gov/pubmed/?term=10.7326%2FM14-2957.

6. McKenney JM. Understanding PCSK9 and anti-PCSK9 therapies. J Clin Lipidol. 2015;9:170–186. http://www.lipidjournal.com/article/S1933-2874(15)00002-1/fulltext?mobileUi=0

7. Li C, Lin L, Zhang W, et al. Efficiency and safety of proprotein convertase subtilisin/kexin 9 monoclonal antibody on hypercholesterolemia: a meta-analysis of 20 randomized controlled trials. J Am Heart Assoc. 2015;4:e001937. doi: 10.1161/JAHA.115.001937.