From the PLA President: We Live in Fantastic Times

Dr. Rosenblit: I am honored to serve as President of the NLA’s Pacific Lipid Association (PLA) Chapter. The PLA membership and its board represent diversity of thought and expertise, but our unity lies in an enthusiasm for atherosclerosis prevention through lipid management. We have a responsibility, based on the best available recommendations, to the provision of best possible care to our individual patients, and, guidance to member and non-member health care professionals, either oneon- one, with inquisitive colleagues, or through other larger educational activities. While attempting these achievements, we often face barriers or resistance, such as insurance coverage restrictions in obtaining a desired biomarker test or an imaging study, or using a desired pharmacologic approach, due to formulary limitations or proprietary drug indications, limiting use to the dictated prescribing information. Furthermore, when so many clinical trials have yet to be designed, we lack level-1 evidence answers to many of our burning atherosclerosis prevention questions.

Additional dilemmas faced are the many surprising negative randomized controlled trials (RCTs) and resultant controversies that challenge us to clarify. Plagued with such trials, we explain the result, not necessarily by a drug that does not work, but by a design flaw, or an in-trial mishap. We heavily rely on positive trials for guidelines. CARDS was a “patients with diabetes-dedicated” RCT that demonstrated significant statin therapy benefits. But another similar diabetesdedicated cohort, ASPEN, and populations of patients with diabetes, in other large RTCs, i.e. ALLHAT and ASCOT-LLA, received no statistical benefit from statins. The latter negative results were explained, at least in-part, by in-trial mishaps of placebo statin drop-in; so we tend to forget these “negative” trials. The results of meta-analyses, which include both positive and statistically insignificant trials, help us with the conglomerate of trials. Adding to the ever-present negative skepticism are media-driven opinions on the risk of diabetes with statin use. Presumably wellmeaning pundits still quote ENHANCE and ARBITER-6 (HALTS), as demonstrations of ezetimibe’s failure to benefit, even though the wrong population was studied in the former trial, and CIMT progression was slowed or halted by the drug in the latter placebo-less trial. We still hear about the failure of fibrates as add-on therapy to statins, based on ACCORD-Lipid, but those quoting the negative trial, fail to qualify the statement, by not describing the prior four major monotherapy fibrate trials that, albeit, post-hoc and hypothesis-generating, demonstrated consistently (emphasis added) that fibrates provide benefit to those with moderate hypertriglyceridemia (>200 mg/dL) and/or low HDL-C, compatible with fibrate mechanisms of actions. We still continue to hear about the failure of niacin in AIM-HIGH and HPS2-THRIVE, among populations of participant CAD patients, already LDL-C, Non-HDL-C and Apo B optimized, prior to randomization, and not likely to benefit, at least, in the usual trial duration. We hear about the failure of low dose omega-3 fatty acid trials, when perhaps high doses may be required. These “negative” study results, understandably, had an impact on the unique 2013 level-1-evidence-basedonly ACC/AHA guidelines. Unqualified media-driven conclusions, clearly, have had an impact on colleague physicians and patients, who often discontinue these medications; the only available adjuncts to statin therapy in the “residual risk” setting. Fortunately, NLA experts, even in the face of a negative RCT, often glean important information, addressing and qualifying the setting, with a conversion to useful and ethical information and provide their membership with website position, opinion or action statements.

While we await the potential for expanded use of newly marketed, and also new more potent investigational products, there is much anticipation with the “NLA Recommendations for Patient-Centered Management of Dyslipidemia,” as an adjunct to, or harmonization with, the 2013 ACC/AHA guidelines as well as the many other technical and scientific, national and international guidelines of the past few years. The NLA membership has had the opportunity to add critiques and commentaries to the initial draft submitted by its expert panel members and the Executive Summary is due this Fall. Certainly, implementing these evidencebased recommendations will occupy our agendas, at least, over the next few years, to permit the delivery of the best possible care to our individual patients and guidance to those who deliver that care; these are the best of times for prevention of atherosclerosis.

Dr. Bottenberg: Welcome to this edition of the Lipid Spin. The Board of Directors of the Pacific Lipid Association (PLA) have decided to focus our issue on the concept of “novel.” Merriam-Webster defines novel as “new and not resembling something formerly known or used.” We are privileged to be witnessing dramatic changes in the diagnosis and treatment of lipid disorders, as well as the way we view science. The National Lipid Association (NLA) and its chapters are playing a large role as these novel changes arise.

We are seeing the development of new classes of lipid medications including antisense oligonucleotides, microsomal transfer protein inhibitors (MTP), novel peroxosimal proliferator activating receptors agonists, and diacylglycerol acyl transferase-1 inhibitors (DGAT-1), among others. We are focusing on outcomes.

The NLA has been very busy with publications during the past year. The Statin Safety Task Force has published an excellent paper that answers many patient questions. This is a “must read” for us all. Also, the NLA’s Recommendations for Patient-Centered Management of Dyslipidemia is quite valuable to those of us treating patients with lipid disorders. I am impressed that we have a document that recognizes that we treat individual patients and not cohorts of patients. The Spring Clinical Lipid Update in Maui, Hawaii, was devoted to recognizing the differences in various cultures around the world. We recognized that risk is calculated differently in various populations and that it may need to be treated differently as well. We asked our speakers to keep the content directed toward clinicians who treat patients within these different populations. This meeting was one of my favorites.

The NLA Annual Meeting in Orlando, Fla., focused heavily on raising awareness of familial hyperlipidemia (FH). The challenges of making an appropriate diagnosis were discussed in detail, the need for cascade screening was emphasized, and decisions on when to begin lipid therapy was debated. The meeting was quite a success.

My tenure as president of the PLA has been one of the highlights of my career as a physician. I have enjoyed every minute of it. I encourage all who read this to volunteer for the various NLA committees and board positions as they become available. For those without the time, I encourage you to volunteer to speak at your local hospitals and local community groups. Members of the NLA are in a great position to usher in these changes let’s continue to lead with novel ideas and strategies