MedicalResearch.com Interview with:
Dr. Eli M. Roth MD, FACC
President, Medical Director
Sterling Research Group
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: At this year’s AHA 2016, we presented a pharmacodynamics analysis of ODYSSEY CHOICE I, which evaluated the effects of Praluent 300 mg administered every four weeks (Q4W) for 24 weeks in hypercholesterolemia patients at moderate to very high cardiovascular risk who were on maximally tolerated statin or no statin and/or other lipid-lowering therapies.
The pharmacodynamic analysis of CHOICE I in patients on statins supports the use of Praluent 300 mg Q4W as an alternative starting dose for patients who prefer a Q4W dosing regimen and demonstrates the value of LDL-C based dosing interval adjustment. The findings from this analysis were consistent with prior ODYSSEY Phase 3 studies, showing that Praluent substantially reduced circulating free PCSK9 concentration, resulting in significant LDL-C reductions. Additionally, Praluent was generally well tolerated.
MedicalResearch.com: What should readers take away from your report?
Response: Readers should understand that despite statins, diet and other lipid-lowering therapies, there remains significant unmet need for patients with heterozygous hypercholesterolemia or clinical atherosclerotic cardiovascular disease who are not at their LDL cholesterol goal.
The findings from this analysis further enhance the meaningful value in LDL cholesterol reduction that Praluent provides to these appropriate patients. Additionally, this analysis helps support the potential benefits of a Q4W 300 mg dosing option for Praluent.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: The most important area of exploration for PCSK9 inhibitors continues to be cardiovascular outcomes research. Such studies are underway, and results will significantly improve our understanding of this new class of cholesterol-lowering therapies. In the case of Praluent, the 18,000-patient ODYSSEY OUTCOMES trial is prospectively evaluating the potential effect of Praluent on CV outcomes in patients who need additional LDL cholesterol lowering after a recent acute coronary syndrome, such as a heart attack, and is on track to be completed next year.
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Disclosures: Study supported by Sanofi and Regeneron
Abstract 16611: Pharmacodynamic Relationship Between PCSK9, Alirocumab, and LDL-C Lowering in the ODYSSEY CHOICE I Trial
Eli M Roth, John J Kastelein, Christopher P Cannon, Michel A Farnier, James McKenney, A. Thomas DiCioccio, Aurelie Brunet, Garen Manvelian, William J Sasiela, Marie T Baccara-Dinet, Guillaume Lecorps, Jennifer G Robinson
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