Year in Review: Top Stories in Lipid Management During 2020

As part of our Year in Review series, Practical Cardiology’s editorial staff has put together a curated list made up of the most viewed and clinically impactful stories from various subspecialties in cardiology.

While 2020 has been a historic year by every stretch of the word, lipid management also witnessed historic advances in the past year. Within the first 3 months, the FDA made 2 landmark approvals and issued a CRL to Novartis for the NDA related to inclisiran, which many expect to be the next lipid-lowering drug to receive FDA approval. The year also brought data related to other new therapies, including evinacumab and EPA/DHA (Epanova). To commemorate the advances in lipid management in 2020, here is our list of the most important stories in lipidology from the past year.

Bempedoic Acid/Ezetimibe Receives Historic FDA Approval

This approval was actually the second in less than a week, with the first coming from bempedoic acid (Nexletol) and the second being awarded to the combination therapy with bempedoic acid/ezetimibe (Nexlizet). With its approval, the combination therapy became the first non-statin, LDL-C lowering combination therapy ever to receive FDA approval.

FDA Issues CRL for Inclisiran, Cites Facility Inspection Issue

Based on a staggering amount of data produced by the ORION program, many expected inclisiran to receive approval in late 2020. Yet, like with so many things in 2020, the approval process took an unexpected turn when the FDA issued a CRL ahead of the December 23 PDUFA date.

After receiving the CRL, which cited unresolved facility inspection issues, Novartis released a statement stating conditions referenced in the letter would be conveyed to the European manufacturing facility responsible for producing the drug.

Inside Cardiology: Bempedoic Acid

During 2020, we launched our video program Inside Cardiology. Created with the idea of bringing unbiased, clinically impactful discussions between practicing clinicians and leading experts or clinical trialists.

For our inaugural episode, Practical Cardiology’s Chief Advisory Board Member Guy Mintz, MD, having an in-depth conversation around the use of bempedoic acid with Steve Nissen, MD, an investigator from the pivotal CLEAR program.

Guy Mintz, MD: National Cholesterol Education Month 2020

Every year, September is recognized as National Cholesterol Education Month. To celebrate, we reached out to Guy Mintz, MD, and had a lengthy conversation with him not only on the importance of educating clinicians on the importance of cholesterol but also educating patients.

Deepak Bhatt, MD: STRENGTH, REDUCE-IT, and DHA

After REDUCE-IT demonstrated icosapent ethyl had the ability to lower triglyceride levels and reduce cardiovascular events, many waited anxiously to learn the results of STRENGTH trial, which examined AstraZeneca’s EPA/DHA combination Epanova. However, unlike REDUCE-IT, the STRENGTH trial failed to meet its mark.

Despite being different agents, some drew comparisons between the two trials, which would end up being discussed as much as trial results in the days following presentation at AHA 2020. For more perspective on the debate, we reached out to Deepak Bhatt, MD, MPH, for his perspective.

Phase 2 Trial Suggests Evinacumab Cuts LDL-C by 50% in Refractory Hypercholesterolemia

At the same conference where STRENGTH was presented, clinicians got a glimpse into the effects of evinacumab in patients with refractory hypercholesterolemia. Data from a phase 2 trail, which examined evinacumab in both subcutaneous and intravenous doses, indicated the fully human monoclonal antibody that inhibits angiopoietin-like protein 3 lowered LDL-C by more than 50% in patients with refractory hypercholesterolemia.