The first completed phase 3 study in the ODYSSEY development program demonstrates that alirocumab is significantly better in lowering LDL cholesterol, as compared with ezetimibe, according to data recently published in Future Cardiology.
Further, the safety profile of alirocumab is comparable to ezetimibe.
The report detailing the results of the phase 3 ODYSSEY MONO trial evaluated the new lower 75-mg dose of alirocumab administered subcutaneously every 2 weeks as monotherapy vs. ezetimibe 10 mg per os each day as a control.
Patients with LDL cholesterol between 100 mg/dL and 190 mg/dL and not on lipid-lowering therapy were included in the study. All patients also had to have a moderate cardiovascular (CV) risk, defined as a 10-year risk for fatal CV events of ≥1% to 5% based on the European Systematic Coronary Risk Estimation (SCORE).
The data suggested that 75-mg dose of alirocumab administered subcutaneously every 2 weeks may be appropriate for lowering adequate lowering of LDL cholesterol in a large portion of patients with primary hypercholesteorlemia at moderate CV risk who are not receiving statin therapy.
The researchers similar rates of adverse events and study discontinuation in both 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," lead study author Eli M. Roth Medical Director, Sterling Research Group & Professor of Clinical Medicine University of Cincinnati, said in a press release. "These completed trials show that PCSK9 inhibitors are proving to be effective in different patient populations."
Sean Fitzpatrick, Commissioning Editor of Future Cardiology, also discussed the findings.
"Following the presentation of Sanofi/Regeneron's positive top-line results at the end of 2014, we feel it is important for our readers to have a comprehensive, accessible overview of this important topic. The review article helps in providing context for clinicians and researchers framing the results in terms of the current state of the art in lipid-lowering therapy."
Alirocumab is a fully human monoclonal antibody to PCSK9. The ODYSSEY MONO study was the first alirocumab phase 3 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.