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: Clinical trials of lipid-lowering therapies (LLTs), including statins, often report variations in treatment response regarding effects on low density-lipoprotein cholesterol (LDL-C) levels, although LDL-C reductions are fairly consistent between trials. Praluent is generally well tolerated, however hyporesponsiveness exists in few patients.
Potential causes for variation in patient responsiveness to Praluent include lack of receipt of active study drug, changes in concurrent LLTs, inaccurate or unrepresentative baseline lipid levels, concurrent acute-phase illness, and biological nonresponsiveness.
This analysis evaluated patients pooled from 10 ODYSSEY trials to assess characteristics of patients with hyporesponsiveness to Praluent, defined as <15% LDL-C reduction from baseline at all analyzed time points.
Overall, only 1% of patients (n=33) had <15% LDL-C reduction at all time points. Prolonged hyporesponsiveness to Praluent was rarely associated with Praluent antidrug antibodies. Of the 33 patients with <15% LDL-C reduction at all study timepoints, 27 had undetectable or missing alirocumab levels, absence of pharmacokinetics analyses, or early treatment discontinuation.
MedicalResearch.com: What should readers take away from your report?
Response: Despite variations in patient responsiveness, overall Praluent has shown a consistent benefit as an additional therapy to high-intensity statins in patients with clinical atherosclerotic cardiovascular disease (ASCVD) and/or heterozygous familial hypercholesterolemia (HeFH).
Praluent provides meaningful value in LDL-C reduction to appropriate patients. Hyporesponsiveness to alirocumab appeared to be due to lack of receipt of alirocumab, possible lack of adherence to concurrent LLT, and a theoretical and rare possibility of biological nonresponsiveness.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: We believe cardiovascular outcomes trials (CVOTs) will ultimately determine the long-term value of the PCSK9 inhibitor class. As such, 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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Citation: AHA 2017 abstract
Characteristics of Patients with < 15% Reduction in Low-Density Lipoprotein Cholesterol with Alirocumab (Bays)
Abstract # S2114
Sunday, November 12, 3:15 PM – 4:30 PM PT
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