ODYSSEY MONO: Effect of Alirocumab 75 Mg Subcutaneously Every 2 Weeks As Monotherapy Versus Ezetimibe Over 24 Weeks

ABSTRACT 

Alirocumab is a fully human monoclonal antibody to PCSK9. The ODYSSEY MONO study was the first alirocumab Phase III study to test a previously unused dose of 75 mg subcutaneously every 2 weeks in a population on no lipid-lowering therapy. A total of 103 patients were randomly assigned to alirocumab starting at 75 mg subcutaneously every 2 weeks or ezetimibe 10 mg per os every day with alirocumab dose uptitration at 12 weeks based on achieved LDL-cholesterol level at week 8 and followed to week 24. At the week-24 primary end point, the alirocumab intent-to-treat group showed a 47.2% (least square [LS] mean) reduction in LDL-cholesterol compared with a 15.6% (LS mean) reduction with ezetimibe (LS mean difference of 31.6%; p < 0.0001). Safety parameters and adverse events were similar between the two groups.

KEYWORDS :

• alirocumab
• ezetimibe
• hypercholesterolemia
• LDL-C
• PCSK9
• SAR236553/REGN727

Disclaimer

In addition to the peer-review process, with the author(s) consent, the manufacturer of the product(s) discussed in this article was given the opportunity to review the manuscript for factual accuracy. Changes were made at the discretion of the author(s) and based on scientific or editorial merit only.

Financial & competing interests disclosure

EM Roth is an employee of a research company that receives grants from Sanofi, Regeneron, Pfizer, Esperion and Lilly (those currently developing lipid-modifying drugs) and is a consultant to Regeneron and Sanofi. JM McKenney is an employee of a research company that receives grants from Sanofi, Regeneron, Pfizer, Esperion and Lilly (those currently developing lipid-modifying drugs). The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.