MedicalResearch.com Interview with:
Dr. Jay Edelberg MD, PhD
VP Head of CV Development and
Head Global CV Medical Affairs
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Patients with heterozygous familial hypercholesterolemia (HeFH) are often not able to achieve their target low-density lipoprotein cholesterol (LDL-C) levels, and some may require lipoprotein apheresis (LA) to lower their “bad cholesterol.” Apheresis is a procedure similar to kidney dialysis, where bad cholesterol is mechanically removed from the blood. It is an invasive, expensive, and time-consuming treatment for patients, as well as physicians.
The Phase III ESCAPE clinical study looked at the potential effect of LA on total Praluent, free and total PCSK9 concentrations, as well as the combined pharmacodynamics effect of total Praluent on LDL-C-lowering.
Praluent levels remained unaffected by apheresis, and Praluent consistently suppressed free PCSK9 levels in patients with HeFH, regardless of LA treatment. This analysis further confirms clinical ESCAPE data that Praluent can be used in conjunction with LA and may reduce or potentially eliminate the need for LA in some patients.
MedicalResearch.com: What should readers take away from your report?
Response: Analyses from the ODYSSEY ESCAPE trial show that Praluent can be used in conjunction with LA and may reduce or potentially eliminate the need for LA in some patients. Praluent provides meaningful value to patients who are unable to achieve their LDL-cholesterol goal, despite treatment with maximally tolerated doses of oral lipid-lowering therapy.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: We are committed to reducing the burden of high LDL-C, particularly in high-risk patients, such as those with cardiovascular (CV) disease. We continue to study the value of Praluent through our robust ODYSSEY clinical trial program.
Currently, we are focused on ODYSSEY OUTCOMES, our landmark trial and the only PCSK9 inhibitor CV outcomes trial designed to evaluate the benefit of an early PCSK9 inhibitor initiation after a recent acute coronary syndrome (ASC) event. It will provide the most robust evidence of any PCSK9 inhibitor CV outcomes trial for a recent ACS population, following more than 18,000 patients for up to five years. ODYSSEY OUTCOMES is completing on track with result reporting in 2018.
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