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ODYSSEY MONO: Alirocumab monotherapy superior to ezetimibe for LDL reduction
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WASHINGTON — Patients with hypercholesterolemia assigned alirocumab, a PCSK9 inhibitor, had greater reductions in LDL at 24 weeks compared with patients assigned ezetimibe, according to the results of the phase 3 ODYSSEY MONO study.
In an intention-to-treat analysis, researchers reported at the American College of Cardiology Scientific Sessions that patients assigned alirocumab (Sanofi/Regeneron) had a mean LDL reduction of –47.2% at 24 weeks vs. –15.6% for those assigned ezetimibe (Zetia, Merck). The mean difference between the two groups was –31.6% (95% CI, –40.2 to –23).
Eli M. Roth, MD, FACC, professor of clinical medicine at University of Cincinnati and medical director of Sterling Research Group, and colleagues evaluated the efficacy and safety of alirocumab monotherapy compared with ezetimibe at 24 weeks. The study included 103 patients (mean age, 60 years; 53% men) with hypercholesterolemia and moderate CV risk who were not taking statins or other lipid-lowering therapies.
Eli M. Roth
Patients were randomly assigned alirocumab 75 mg every 2 weeks plus daily oral placebo or ezetimibe 10 mg daily plus injectable placebo every 2 weeks. At week 12, 14 patients in the alirocumab group were up-titrated to 150 mg every 2 weeks because their LDL was ≥70 mg/dL.
Expected results achieved
“The data from the phase 2 studies that we modeled suggested a 75-mg dose would give about a 50% reduction in LDL,” Roth told Cardiology Today. “And that’s pretty much where we ended up.”
One patient in each arm reported a serious adverse event. According to the researchers, a patient in the alirocumab arm with a history of atrial fibrillation and chronic obstructive pulmonary disorder experienced pulmonary embolism, and a patient in the ezetimibe arm with a history of shoulder arthritis experienced glenoid erosion. In both cases, researchers ruled that the effects were not related to the study treatment.
Treatment-emergent adverse events occurred in 69.2% of the alirocumab group vs. 78.4% of the ezetimibe group, Roth and colleagues found. The most common adverse event was nasopharyngitis (alirocumab group, 23.1%; ezetimibe group, 15.7%). Injection-site reactions were few, possibly because ODYSSEY MONO was the first trial of a PCSK9 inhibitor to use a disposable autoinjector, according to the researchers.
Patient adherence good
Roth told Cardiology Today that adherence with the self-injection was not an issue for patients in this study.
“The relatively small needle is automatic. You press it to your skin, push the button down and wait to hear a click. It takes about 10 seconds. Most of the patients said they hardly felt anything at all,” he said.
ODYSSEY MONO was the first of 14 phase 3 studies of alirocumab to report results, Roth said. “Ten of the 14 studies will be reported later this year. They are looking at various dosage and timing strategies, as well as different groups of patients.” – by Erik Swain
For more information:
Roth EM. Abstract #1183-125. Presented at: American College of Cardiology Scientific Sessions; March 29-31, 2014; Washington, D.C.
Disclosure: The study was funded by Sanofi and Regeneron. Roth is employed by Sterling Research Group, which has received research funds and consulting fees from Amgen, Regeneron and Sanofi.