September 3, 2019 – A study led by a DCRI faculty member provides additional clarification on which patients may benefit the most from additional lipid-lowering therapies, if their cholesterol levels remain elevated despite optimal statin therapy.
A new DCRI-led study applied recently published guidelines on cholesterol management from the American College of Cardiology (ACC) and the American Heart Association (AHA) and confirmed that patients at the highest risk may benefit from lipid-lowering treatments in addition to statins.
The ACC/AHA Guidelines on the Management of Blood Cholesterol, published in December 2018, updates the 2013 guidelines and provides more guidance on newer lipid-lowering therapies that can lower cholesterol levels beyond what can be achieved with statins. By recommending the use of these classes of lipid-lowering drugs, which include ezetimibe and PCSK9 inhibitors, for patients with established atherosclerotic cardiovascular disease (ASCVD) and at high risk, the new guidelines promote more personalized treatments for individual ASCVD patients.
The study, which was recently published in Circulation, applied the updated guidelines to patients included in the ODYSSEY OUTCOMES trial, for which the DCRI served as the academic coordinating center from 2012-2018. Results of this trial, which were presented at the ACC 2018 Scientific Sessions, showed that alirocumab, a PCSK9 inhibitor, reduced cardiovascular events when compared with placebo in ASCVD patients with a recent acute coronary syndrome (ACS) and residual dyslipidemia, meaning they had not reached target cholesterol levels with optimized statin therapy.
The study was led by Matthew T. Roe, MD, MHS, (pictured), who was the DCRI faculty leader for the ODYSSEY OUTCOMES trial. Because the updated cholesterol management guidelines were published after the trial results were released, Roe and colleagues were interested in conducting an exploratory analysis to apply the guidelines risk stratification recommendations and determine which patients received the most benefit from the randomized study drug (alirocumab).
The study included 18,924 patients, with 11,935 (63 percent) classified as very high risk based upon the updated guidelines’ risk categorizations. The frequency of cardiovascular events was highest in those patients classified as very high risk and these patients had a greater absolute reduction in the frequency of cardiovascular events from treatment with alirocumab compared with patients classified as not very high risk.
“Through these analyses, we have provided some key messages that will help clinicians decide how to apply the updated cholesterol management guidelines in clinical practice,” Roe said. “Namely, we should target the use of additional lipid-lowering therapies, such as PCSK9 inhibitors, for very-high risk ASCVD patients with residual elevated cholesterol levels despite statin therapy because this population was found to benefit the most.”
Other DCRI contributors to this study include Renato Lopes, MD, PhD.