This article is more than 5 years old. Information may no longer be current.
ODYSSEY MONO: PCSK9 inhibitor bests ezetimibe for LDL reduction
Click Here to Manage Email Alerts
Alirocumab, a PCSK9 monoclonal antibody, was associated with greater reductions in LDL than ezetimibe in patients with primary hypercholesterolemia and moderate CV risk, according to top-line results from a phase 3 study.
At 24 weeks, LDL was reduced by 47.2% among patients assigned alirocumab compared with 15.6% among patients assigned ezetimibe (P<.0001), according to a press release from Sanofi and Regeneron Pharmaceuticals.
ODYSSEY MONO is the first of 12 ODYSSEY studies to report phase 3 results. The 12 studies to evaluate alirocumab, formerly known as REGN727/SAR236553, will include more than 23,000 participants.
ODYSSEY MONO was a randomized, double blind, active-controlled, parallel-group study conducted in 103 patients with primary hypercholesterolemia and moderate CV risk. According to the ODYSSEY MONO page at clinicaltrials.gov, patients were randomly assigned oral ezetimibe 10 mg/day (Zetia, Merck) plus subcutaneous placebo every 2 weeks or subcutaneous alirocumab 75 mg every 2 weeks plus oral placebo once daily. If, at 8 weeks, a patient assigned alirocumab had LDL >70 mg/dL, the patient was up-titrated at week 12 to 150 mg of alirocumab every 2 weeks. The majority of patients assigned alirocumab did not require up-titration, according to information in the press release.
The rate of treatment-emergent adverse events was 69.2% in the alirocumab group vs. 78.4% in the ezetimibe group. The most common adverse event was infection (alirocumab group, 42.3%; ezetimibe group, 39.2%), including nasopharyngitis, influenza and upper respiratory tract infection.
Alirocumab works by blocking PCSK9 and increasing the number of LDL receptors on hepatocytes, lowering LDL.
Detailed results from the study will be presented at a conference in 2014, according to the press release.