The Significance of NLA Scientific Statements and Clinical Perspectives

Since its inception, the National Lipid Association has produced significant contributions to the scientific literature, creating practical guidance for Clinical Lipid Specialists, as well as the general clinical and public health communities. These publications have cemented NLA’s prominence in pursuit of its mission to enhance the practice of lipid management in clinical medicine. Several of our scientific statements have led to tangible changes in clinical practice, national clinical guidelines, and improved patient outcomes.

Our first significant contribution was in 2006, a discussion on whether the ratio of safety to benefit associated with statin therapy was sufficient to justify their widespread use. Led by James M. McKenney, PharmD, CLS, FNLA, Michael H. Davidson, MD, FNLA, Terry A. Jacobson, MD, FNLA and John R. Guyton, MD, FNLA; this NLA Satin Safety Task Force brought the NLA to the forefront in the field. The timing of the statement was crucial since it was during a period when the value and safety of statin therapy was being questioned. The statement reaffirmed the overwhelming safety of statins and how their benefit to risk ratio made them the cornerstone of drug therapy for both the primary and secondary prevention of cardiovascular disease. In addition, the statement eventually led the way for the FDA to withdraw the stringent requirements of frequent liver function test monitoring during statin therapy and reaffirmed the relatively safety of statins in liver disease.

After producing three sets of Clinical Cholesterol Guidelines labeled the “Adult Treatment Panel” I, II, and III, the National Heart Lung and Blood Institute (NHLBI) decided to discontinue guideline development and turned over the responsibility to the American Heart Association (AHA) and the American College of Cardiology (ACC). In 2013, we saw the first ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk on Adults. Although these guidelines were initially controversial, they stimulated the NLA’s interest in creating additional recommendations to more comprehensively address issues relevant to dyslipidemia management, leading to the NLA's Recommendations for Patient-Centered Management of Dyslipidemia Parts 1 and 2 ("Recommendations") in 2014 and 2015 respectively. Using an evidence-based approach derived from randomized controlled trials (RCTs), meta-analyses of results from RCTs, and review of results from observational, genetic, metabolic, and mechanistic studies, the NLA set out to supplement
the 2013 ACC/AHA Cholesterol Guidelines with further recommendations and to help fill in the gaps where
clinical judgement was required. The NLA's Recommendations provided an internationally recognized, individualized approach to management of dyslipidemia. Part 1 covered the key elements of risk stratification, the importance of LDL-C and Non-HDL-C monitoring, and the use of other therapies besides statins. In addition, it reinforced that the target of therapy was not just LDL-C but all circulating atherogenic Apo B containing lipoproteins as measured in Non-HDL-C or Apo B. The Part 2 Recommendations focused on specifics regarding:

1.    Lifestyle therapies–nutrition and exercise/physical activity;
2.    Groups with special considerations across the lifespan from children to seniors including dyslipidemia management in pregnancy and menopause;
3.    Ethnic groups including Hispanics/Latinos, African Americans (AAs), South Asians, and American Indians/Alaska Natives;
4.    Groups with increased ASCVD risk, including patients with human immunodeficiency virus, rheumatologic disease, and those with high residual risk despite statin and lifestyle therapies;
5.    Strategies to improve patient outcomes by improving adherence and maximizing team-based collaborative care.

The publication of the NLA Recommendations Part 1 and Part 2 helped the organization achieve national and international recognition and cemented our role as experts in Clinical Lipidology. In addition, allowed the organization to find its own voice and continue to be impactful through the efforts of our strong and diverse interdisciplinary membership. Many of the concepts covered in the NLA Part 1 and 2 recommendations were later incorporated into the 2018 AHA/ACC/Multisociety Guideline on the Management of Blood Cholesterol, and the Writing Group for this guideline included representation from NLA leadership.

In 2018, the NLA furthered its commitment to providing meaningful contributions to its membership and the scientific literature with development of the Scientific Statements Committee. The Scientific Statements Committee is charged with facilitating the development and review of clinical topics that are presented to the NLA Board of Directors for approval in areas where clinicians may need guidance. These may include “Scientific Statements“ in where the evidence is clear and compelling, or “Clinical Perspectives” in where high-quality evidence is lacking, requiring application of clinical judgment and consensus expert opinion. The following are the new types of NLA scientific publications:

• NLA Scientific Statement: An NLA Scientific Statement is the official position of the NLA. A Scientific Statement is evidence-based, and all recommendations must be assessed by evidence grades and quality ratings. A Scientific Statement may be developed jointly with other organizations. A Scientific Statement must be adopted by a majority of the Board of Directors and can only be changed or reversed by the Board of Directors.
• NLA Clinical Perspective: A Clinical Perspective is not an official position of the NLA, but the perspective is supported by the NLA. A Clinical Perspective is evidence-based whenever possible, but recommendations do not need to be assessed by an evidence grade or quality rating. A Clinical Perspective must be adopted by a majority of the Board of Directors and can only be changed or reversed by the Board of Directors.

Once a topic is approved by the NLA Board, the Scientific Statements Committee then provides oversite for the writing and publication of the statement. An important goal of the Scientific Statements Committee is to be responsive to the needs of our membership, particularly regarding new developments in the science of lipids or any new research that may affect clinical practice or patient outcomes. Some recent cutting edge NLA statements include the following:

Scientific Statements

1. Lipid Measurements in the Management of Cardiovascular Disease
2. Genetic Testing in Dyslipidemia
3. Coronary Artery Calcium Scoring to Guide Prevention of ASCVD
4. NLA Scientific Statement on the Use of Icosapent Ethyl in Statin-treated Patients with Elevated Triglycerides and High or Very High ASCVD Risk
5. Review of Current Evidence and Clinical Recommendations on the Effects of Low-Carbohydrate and Very-Low-Carbohydrate (including Ketogenic) Diets for the Management of Body Weight and other Cardiometabolic Risk Factors
6. Use of Lipoprotein(a) in Clinical Practice: A Biomarker Whose Time Has Come

Clinical Perspectives

1. Prevention of Atherosclerotic Cardiovascular Disease in South Asians in the US

The future is bright for the NLA’s Scientific Statements and Clinical Perspectives with documents in development on the topics of statin intolerance, statin associated muscle symptoms, treatment of hypercholesterolemia in older primary prevention patients, management of dyslipidemia during the reproductive years, and nutritional interventions for dyslipidemia in youth.