Amassing the Clinical Evidence for Optimized Dyslipidemia Ma - Episode 4

LDL: How Low Should We Go?

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The MD Magazine Peer Exchange “Amassing the Clinical Evidence for Optimized Dyslipidemia Management: Vitamin D, Long-Term Statin Outcomes, and PCSK9 Inhibition” features expert insight and analysis of the latest information on managing hypertension and hyperlipidemia, and in-depth discussion on the use of PCSK9 inhibitors in practice.

This Peer Exchange is moderated by Peter Salgo, MD, professor of medicine and anesthesiology at Columbia University and an associate director of surgical intensive care at the New York-Presbyterian Hospital in New York City.

The panelists are:

  • Christie Ballantyne, MD, Co-director of the Lipid Metabolism and Atherosclerosis Clinic at The Methodist Hospital, Director of the Center for Cardiovascular Disease Prevention at the Methodist DeBakey Heart Center, and the Chief of Cardiology at Baylor College of Medicine
  • Keith C. Ferdinand, MD, Immediate Past Chair of the National Forum for Heart Disease and Stroke Prevention, and Professor of Clinical Medicine at the Heart and Vascular Institute at Tulane University School of Medicine
  • Jennifer G. Robinson, MD, MPH, Professor in the Departments of Epidemiology & Medicine and Director of the Prevention Intervention Center, Department of Epidemiology at the College of Public Health, University of Iowa
  • Karol E. Watson, MD, PhD, Professor of Medicine and Cardiology, Co-director of the UCLA Program in Preventive Cardiology, and Director of the UCLA Barbra Streisand Women’s Heart Health Program

In this segment of the Peer Exchange, the panelists discuss clinical factors that should be taken into consideration when placing a patient on statin therapy to lower their LDL levels. They also talk about the strengths and weaknesses of the clinical data being used to inform treatment decisions.

Ballantyne notes that ezetimibe is not used much in practice in patients with and LDL of 70 because treatment would likely only produce an incremental LDL reduction with concomitant small reduction in risk. The drug is more frequently used in patients with higher LDL levels who are not responding well to statin treatment. He says the issue that then comes up for both clinicians and patients is, “Well, when do I really need to add a second drug?” Unfortunately, there has been “a lot of confusion as to where LDL is not that important if there’s no target. If I don’t need to check LDLs, then why would I add a second drug?”

Salgo notes “there’s seven years of data on ezetimibe added to simvastatin, reducing the primary composite endpoints of cardiovascular death, myocardial infarction‑‑not just in people with acute coronary syndrome but seven years down the pike, right?”

In Watson’s opinion, it is a good thing that it took seven years for the data to develop. “It took a long time to see this benefit, and I think that’s important. We get used to seeing clinical trial results in four or five years. That’s not how life happens. So waiting seven to nine years to see a significant benefit for this drug was worth it,” she says.

While this long time frame may be a good thing, Ferdinand notes that it also “points out some of the flaws of clinical trial evidence. It may be the best evidence, it may be the evidence on which we base our guidelines, but it’s still flawed. There are inclusion criteria and there are exclusion criteria. There are nuances in how sites are determined. There are differences in terms of race, ethnicity, and social economic status, and a lot of those cannot really be analyzed when you come to that two or three sentence conclusion of the study. So we have to really read clinical trials with a lot of, I don’t want to say disbelief, but let’s say at least looking at them in a more special manner.”

Coming to the defense of the cholesterol guidelines data, Robinson says, “Because I was the vice chair for the cholesterol guidelines, I want to be clear that there are different amounts of evidence for different treatments. We looked at 28 statin trials in over 200,000 people. There’s not a more robust database for anything in the world, and it encompassed a wide range of people, people with heart failure and end-stage hemodialysis. And there was a lot of primary and secondary prevention.”

Although the cohort was underrepresented for racial and ethnic groups, from the evidence obtained it looked like the effects were similar. “So I want to make a differentiation between the statin evidence, and I think our audience needs to understand that evidence is robust. It’s strong and it’s consistent. There is no question that that’s not applicable to clinical practice,” she concludes.