From the SWLA President: Guidelines + Guidance Lines

“If you would not be forgotten as soon as you are dead and rotten, either write things worth reading or do things worth the writing.” – Benjamin Franklin

The National Lipid Association is the premier organization dedicated to advancing our knowledge about the optimal approach to diagnosing and treating patients with lipid disorders. Any success of the organization is directly related to the diverse nature of our members. The NLA membership crosses multiple medical disciplines and specialties in a manner that is totally unique. The unifying theme of the organization is that we operate best “as a team.” This mutual respect among the membership is the single greatest source of our influence and our strength. It is our responsibility to assure that we advocate and approach the best practice model to provide care for our patients’ lipid disorders. It is our obligation to communicate the most accurate level of information — in a timely manner — to our members as well as the many non- member practitioners who look to us for direction.

Recently, as an American College of Cardiology (ACC) representative, I had an opportunity to review the indications for genetic testing for clopidogrel resistance. This is a dilemma facing interventional cardiologists every day because of a wide variation in patient responses to this agent (used to maintain cardiac stent patency). Genetic variations have documented that a patient’s likelihood of a failure of therapeutic response (non-responders) varies between 3 to 4 percent (Caucasian), 12 to 14 percent (African), and almost 40 percent (South Asian Indians). Given this widespread response, it seemed reasonable to explore the possibly of recommending testing to identify clopidogrel responders. The committee was limited in our decision by four bench marks, which we were able to utilize to make this decision.

1. An FDA-approved test is readily available.
2. The laboratory test would be able to differentiate responders from non- responses.
3. The cost would be reasonable.
4. When practitioners utilized the test there would be a favorable improvement in the population of patients that we studied compared to a population that did not have access to the test.

The first three benchmarks were relatively easy to attain. It was the fourth benchmark that proved difficult (principally because of a lack of controlled studies). Sadly, because of the fourth benchmark, we were not able to advocate the widespread use of this genetic test as a guideline. This project, I believe, provides the NLA with an opportunity.

Over the course of the last several years, there has been a plethora of guidelines promoted to help us deal with patients’ cholesterol problems. Sadly, only a small minority of the patients that we see in the office every day would qualify for inclusion in the very studies these guidelines are based. Translating an approach that applies to a few patients (those in clinical trials) into the many (specifically the one patient in your office that you are treating that day) is a challenge encountered by every practitioner on a daily basis. The NLA has an opportunity to serve as a “clinical reservoir” to provide accurate, unbiased, and clinically relevant information. This source of guidance would allow the NLA to maintain the highest standards in clinical lipidology. The NLA’s goal must always remain to maximize opportunity in order to make the best clinical decisions for the patient. It is in this context that I would advocate we consider promoting “guidance lines.” These would be in addition to our current guidelines and, ideally, would be utilized as a “team” approach. The purpose of this approach would not be to replace guidelines, but to partner with them in order to maximize our chances for success, especially in those patients we may have a hard time fitting into the guideline model.

We, as the experts in the field of clinical lipidology, have the ability to provide direction not only for our patients, but also for all practitioners. In addition to the guidelines, the NLA should consider guidance lines to be based on best practice models. We may consider the following points to start the discussion regarding just what a guidance line actually is. Patterned after the previously discussed clopidigrel, the NLA may want to consider the following inclusion points (the four A’s):

1. FDA approved therapy (Available)
2. Reasonable cost (Affordable)
3. Capable of identifying non-responders (Accurate)
4. Our ability to prove that the actions what we are recommending do actually improve our patients’ lives and reduce clinical events (Advantageous)

Through its membership, the NLA is in an ideal position to provide our patient contacts to populate such a database. This would allow us to create patient registries and would give us the opportunity to partner with our preventative colleagues such as the American College of Cardiology, Preventive Cardiology Nursing Association, or Million Hearts^®: Cardiovascular Disease Risk Reduction Model. I can envision the organization playing a vital role in this effort to advance lipid therapy. Many of the questions that our clinical practice poses to us on a daily basis may never be answered by double blind mega trials, but I believe that a small dedicated group of individuals such as the NLA could provide valuable information that will help clinicians help patients. The NLA lipid registry would be able to advance our knowledge in so many areas. The NLA’s determination to commit to such a project has the ability to transform a “could” proposal into “we did” accomplishment. I envision that successful completion of this task may prove to be the NLA’s single greatest achievement and our proudest legacy.

The NLA’s success should be judged on the membership’s ability to favorably advance knowledge, and widely disseminate that information. Our sole focus remains to improve patient chances of survival and lessens their chances of suffering any cardiovascular event. The keystone component in order to reach this goal is that we must consider adding lipid registries to complement the evidence derived from the double blind placebo controlled mega trials. Our success in this endeavor will not only improve cardiovascular care for our patients but also fulfill Ben Franklin’s challenge of “do things worth the writing.”