A team of cardiologists at the Cleveland Clinic recommended a hybrid approach using previous and new guidelines for treating patients with high cholesterol levels who are at risk of atherosclerotic cardiovascular disease. They praised the simplicity of recently released guidelines but faulted their reliance on randomized clinical trial data and an untested risk calculator.
Chad Raymond, DO, and colleagues made their case in the January issue of the Cleveland Clinic Journal in an article that summarized recommendations and applied the guidelines to hypothetical patients in four targeted populations. Each high-risk group allowed them to illustrate what they viewed as the guidelines’ advantages and shortcomings.
Guideline writers used randomized clinical trial data exclusively to develop recommendations. While randomized clinical trials reign as the gold standard for evidence, they typically exclude a wide spectrum patients who would be seen in a clinical setting. For instance, the guidelines apply to patients between the ages of 40 and 75 because of the paucity of trial data in younger and older patients.
“Prevention only works when started,” Raymond and colleagues wrote. “With childhood and young adult obesity sharply rising, we should not fail to address the under-40-year old patient population in our guidelines.”
The guidelines eliminate treatment goals for low-density lipoprotein cholesterol and high-density lipoprotein cholesterol, based on a lack of proof that targets correlated with hard outcomes. The guidelines instead emphasize a high-intensity and moderate-intensity statin treatment in high-risk patients who meet select criteria, which “should have substantial long-term public health benefits,” the Cleveland Clinic team acknowledged.
No longer tracking cholesterol levels after initiating treatment takes away a patient’s sense of accomplishment and motivation and leaves physicians in the dark about a patient’s response and appropriate approach if the patient experiences side effects, they argued. Using hypothetical cases, they showed the potential for patients to be under- and over-treated, a concern raised with the release of a new risk calculator.
“Importantly, and somewhat ironically given the otherwise absolute adherence to randomized controlled trial data for guideline development, the risk calculator has never been verified in prospective studies to adequately show that using it reduces ASCVD [atherosclerotic cardiovascular disease] events.”
They also listed several situations where they felt therapies in addition to statins were warranted, based on trial and other data. Previous guidelines incorporate evidence beyond clinical trials as well as expert consensus to address scenarios seen in everyday practice.
Raymond and colleagues urged their peers to continue to use cholesterol goals defined in previous guidelines while embracing approaches such as global risk assessment and high-intensity statin treatment recommended in the new guidelines.
The leaders of the two societies that developed the new guidelines discussed the process and upcoming changes in a Q&A with Cardiovascular Business. It is available here.