期刊
FUTURE CARDIOLOGY
卷 11, 期 1, 页码 27-37出版社
FUTURE MEDICINE LTD
DOI: 10.2217/FCA.14.82
关键词
alirocumab; ezetimibe; hypercholesterolemia; LDL-C; PCSK9; SAR236553/REGN727
资金
- Sanofi
- Regeneron
- Pfizer
- Esperion
- Lilly
Alirocumab is a fully human monoclonal antibody to PCSK9. The ODYSSEY MONO study was the first alirocumab Phase III 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. At the week-24 primary end point, the alirocumab intent-to-treat group showed a 47.2% (least square [LS] mean) reduction in LDL-cholesterol compared with a 15.6% (LS mean) reduction with ezetimibe (LS mean difference of 31.6%; p < 0.0001). Safety parameters and adverse events were similar between the two groups.
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