New guidelines have been crafted by the ACC/AHA that have the potential to reshape the landscape of primary care as it relates to statin use.¹ The guidelines clearly articulate that patients who have known coronary artery disease, an extremely elevated LDL (greater than 190), type 2 diabetes, or an estimated 10-year risk for a major coronary event of greater than 7.5% should be on a high-potency statin. Given the decrease in risk of CV events seen in patients on statins, the authors argue that the targeting of particular LDL goal (i.e., <70 or 100mg/dl) may not be necessary.

This dramatic change in guidelines has caught the medical community by surprise. Already arguments have ensued as to accuracy of the assumptions given the underlying science. For example, the novel risk calculator has been deemed flawed by some commentators and critics—perhaps overestimating the risk of CV events in a large proportion of patients.

The intent of this blog post is not to add to those arguments. Rather I hope to raise awareness about the new guidelines and perhaps interject a new discussion point into the conversation occurring online, in print, and in the media. That point revolves around the issues of the “baseline LDL,” repeatedly checking LDL levels, and monitoring adherence.

Keeping Tabs on Statin Use and LDL Levels
As stated by the guideline authors, repeatedly testing LDL during statin use serves an important function for both clinician and patient. That function is a reality check on "adherence."

It is well known that statins work to reduce mortality and major cardiovascular events in “at risk” patients. They only work (as do all medications), to paraphrase former Surgeon General Dr. C. Everett Koop, when they are taken! It is well recognized, however, that adherence rates for medications taken for asymptomatic conditions (such as high cholesterol levels) are low. Several data sets have demonstrated this fact. For example, Evans et al. found an adherence rate of approximately 50%, with adherence defined as taking 80% of the prescribed statin during the course of a the first year after a statin is initiated.²

Of course, non-adherence affects multiple medication classes, especially, as noted above, where the condition being treated does not produce symptoms (osteoporosis, for example). When a patient’s non-adherence is with a drug class that has been shown to be as effective in decreasing multiple significant endpoints (mortality and significant morbidities such as heart attacks and strokes), the issue becomes critical to address at every opportunity. Clearly the effectiveness of statins in reducing major cardiovascular endpoints fits this bill.

Recording the Baseline LDL—A New Twist
The new twist for primary care docs is going to be the recording of the baseline LDL. The authors clearly articulate that patients with diabetes should be on a statin and those diabetics with a 10-year CV risk of >7.5 percent should be on a “high potency” statin where the anticipated reduction of LDL would be at least 50% from baseline. All other patients with diabetes are recommended to take a lower potency statin with anticipated LDL lowering of 30-50%.

These new guidelines leave the primary care doc with a new documentation requirement, i.e., the recording of the baseline LDL. This, in theory, will be straightforward for the patient who is not currently on a statin, has been with the same practice for years, and has not had uninterrupted medical records during that time period. It becomes more problematic for the patient who has been on a statin for years, and where the baseline lipid profile is no longer available. This lack of availability may be due to multiple reasons such as large and unwieldy paper lab records that can be difficult to navigate, the conversion of paper to the electronic medical record where all historical data is not all entered (often a manual process), or incomplete record transfer when a patient is new to a practice.

Navigating New Challenges
Physicians following these new guidelines are going to need to navigate these new challenges. The complexity of the judgment as to whether a patient is adherent to a statin—a question of paramount importance to which practices need to pay increasing attention going forward—has just increased given the issues I raise above with the baseline LDL. For example, if a patient is on atorvastatin and has a current LDL of 98mg/dl that may indicate non-adherence if that patient’s baseline was 102mg/dl, or it may indicate adherence with a wonderful therapeutic response if the baseline was 194mg/dl.

I urge physicians to develop systems solutions to this problem—for example, annotating “hyperlipidemia” in the problem list to "hyperlipidemia with baseline LDL of 194." Adding this information will simplify the adherence judgment for years to come for that particular patient.

Increasingly, practices are also incorporating tools that allow clinicians and staff to peer directly into pharmacy databases to look at the medication refill histories of patients. These tools are part of the revolution brought on by electronic medical records. Practices will need to develop new skills and routines to ensure that these tools are optimally used. What better way to see that the last time a statin was refilled was within the last 30 days—and that there was no interruptions in refills since the last visit?

Such new tools, however, are only as good as there level of utilization within team-based, standard work routines in the practice level. For those practices that have this system in place, the lack of a baseline LDL is not as critical given the more direct ability to judge adherence accurately.

I look forward to further discussion about the evolving landscape of lipid reduction and the points made in this blog post. Please add your comments, below.

REFERENCES
1. Stone NJ, Robinson J, Lichtenstein AH, et al. 2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults: A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol 2013 Nov 7 [Epub ahead of print]

2. Evans, CD, Eurich DT, Lamb DA, et al. Retrospective observational assessment of statin adherence among subjects patronizing different types of community pharmacies in Canada. J Manag Care Pharm 2009;15(6):476-484.