PCSK9 Inhibitor Beats Ezetimibe for LDL Lowering: ODYSSEY MONO

October 16, 2013

PARIS, FRANCE AND TARRYTOWN, NY — Another drug that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9) appears to have cleared a hurdle today, with Sanofi and Regeneron reporting top-line results of the ODYSSEY MONO trial[1].

The monoclonal antibody targeting PCSK9, known as alirocumab, significantly reduced LDL-cholesterol levels when compared with ezetimibe (Zetia, Merck/Schering-Plough) in patients with hypercholesterolemia. For patients treated with alirocumab, the mean reduction in LDL cholesterol was 47.2% vs a 15.6% reduction for patients treated with ezetimibe 10 mg.

Regarding treatment-emergent adverse events, 78.4% in the ezetimibe group and 69.2% in the alirocumab had side effects. The most common adverse events reported with alirocumab were infections such as nasopharyngitis, influenza, and upper-respiratory-tract infections.

The patients were treated with 75 mg of alirocumab subcutaneously every two weeks, and the dose was increased at week 12 to 150 mg every two weeks if the measurement of LDL cholesterol at week 8 was >70 mg/dL. The majority of patients treated remained on the low dose, according to the companies.

ODYSSEY MONO is a 24-week, phase 3 study that included 103 patients, according to clinicaltrials.gov. The companies are currently conducting 11 other phase 3 studies with alirocumab in different patient populations, drug combinations, and dosing regimens. They plan to present the results of ODYSSEY MONO an upcoming cardiology conference in 2014.


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