MedicalResearch.com Interview with:
Prof. Kosh Ray, MB ChB, MD, MPhil
Faculty of Medicine, School of Public Health
Chair in Public Health (Clinical)
Imperial College London
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Bempedoic acid is the first in class of a new therapy for lowering LDL cholesterol. This is the largest and longest study to date with this therapy and involved about 2200 pts with patients with either established cardiovascular disease or familial hypercholestrolaemia and in whom LDL was > 70mg/dl or 1.8 mmol/L despite maximally tolerated statins. %0% were on high intensity statins and the majority of the rest on moderate intensity.
The aim was to show long term safety 1 year and efficacy at 24 weeks and at 1 year.
MedicalResearch.com: How does Bempedoic Acid differ from other LDL reducing agents?
Response: Bempedoic acid targets an enzyme called ATP citrate lyase which is in the cholesterol systhesis pathway and upstream of the enzyme targeted by statins. So like statins works through the LDL receptor. As the drug is a prodrug it is activated to the activate compound in the liver and then can’t leave the liver cell. Hence muscle symptoms reported with statins might well occur less.
MedicalResearch.com: What are the main findings?
Response: On top of maximally tolerated statins there was a further 18% reduction in LDL.
More patients got to target with BA vs placebo. Overall adverse events were similar between Bempedoic acid and placebo with the exception of a small excess risk of gout. Importantly there were no differences in muscle side effects or liver function abnormalities. Bothe efficacy and safety was constant irrespective of background statin therapy and by various subgroups.
MedicalResearch.com: What should readers take away from your report?
Response: There are many patients who cannot tolerate statins or need additional LDL lowering despite statins and ezetimibe. PCSK9 inhibitors are expensive so many patients are left at high risk. This promising new therapy offers help for those individuals and may well become available this year.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: There is an ongoing cardiovascular outcome study called CLEAR OUTCOMES testing whether the addition of BA reduces outcomes.
Disclosures: I consult for all companies developing cholesterol lowering therapies including Esperion the manufacturers of this drug.
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