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Alirocumab Lowers LDL-Cholesterol in Phase III Study

Monoclonal antibody is more effective than ezetimibe

Data from the first completed phase III trial in the ODYSSEY development program have shown that alirocumab (Sanofi/Regeneron) was significantly more effective at reducing low-density lipoprotein cholesterol (LDL-C) compared with ezetimibe (Zetia, Merck), with a safety profile similar to that of ezetimibe.

LDL-C is considered to be a major modifiable risk factor for the development of atherosclerosis and cardiovascular (CV) disease, the leading cause of death worldwide. LDL-C is identified as the primary target of cholesterol-lowering therapy in North American and European guidelines. Statins are the recommended first-line therapy for lowering LDL-C.

Alirocumab (formerly SAR236553/REGN727) is a fully human monoclonal antibody to the proprotein convertase subtilisin/kexin type 9 (PCSK9) enzyme –– the first in this drug class to complete a phase III study.

The ODYSSEY MONO trial evaluated subcutaneous alirocumab (75 mg every 2 weeks) compared with oral ezetimibe (10 mg/day). Inclusion criteria included patients with LDL-C levels of between 100 and 199 mg/dL who had not receiving lipid-lowering therapy. In addition, the subjects were required to have a moderate CV risk, defined as a 10-year risk of fatal CV events of between 1% and 5%, based on the European Systematic Coronary Risk Estimation (SCORE).

The new findings suggest that the 75-mg dose of alirocumab administered subcutaneously every 2 weeks may be appropriate for adequate lowering of LDL-C in a large proportion of patients with primary hypercholesterolemia at moderate CV risk who are not receiving statin therapy.

Safety parameters, adverse events, and study discontinuation rates were similar between the two treatment arms.

“Since ODYSSEY MONO, we have seen several phase III trials that have confirmed the ability of alirocumab to lower LDL-C in moderate- to high-risk cardiovascular patients,” said lead author Dr. Eli M. Roth of the University of Cincinnati. “These completed trials show that PCSK9 inhibitors are proving to be effective in different patient populations.”

Sources: Medical Xpress; February 17, 2015; and Future Cardiology; January 2015.

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