Intensified oral therapies may lower lipid levels; simulation shows gap between guidelines, actual practice

Controlling lipid levels in patients with atherosclerotic cardiovascular disease (ASCVD) can be improved with oral-only lipid lowering treatments, according to new research.

Published Aug. 2 in the JAMA Cardiology, a simulation study showed that 99.3 percent of patients could achieve low-density lipid (LDL) levels below 70 mg/dL with maximal intensification.

Past work has shown reducing low-density lipoprotein cholesterol (LDL-C) with statins in people with established atherosclerotic cardiovascular disease (ASCVD) reduces their risk of cardiovascular events (CVE). Large gaps between expert guidelines and current practice remain when it comes to the use of lipid-lowering treatment in this population, the authors wrote.

The researchers’ goal was to estimate the percentage of patients with ASCVD who would need a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor to reach the recommended LDL levels after the intensification of lipid-lowering therapy (LLT) with other oral agents.

“In our model that assumes no LLT-intolerance and full adherence, intensification of oral LLT could achieve LDL-C levels of less than 70 mg/dL in most patients, with only a modest percentage requiring a PCSK9 inhibitor,” wrote lead author Christopher P. Cannon, with the Bain Institute for Clinical Research and Brigham and Women’s Hospital in Boston, and colleagues.

Their simulation model used a large administrative database of US medical and pharmacy claims based on the experiences of 105,269 patients with ASCVD. All claims were filed in 2012 and 2103. The patients in this study broadly resembled the U.S. populations with ASCVD.

Among this group, only 53.2 percent of the patients were taking statins at baseline, and only 25.2 percent of them reached LDL levels of less than 70mg/dL. The team explored many LLT intensification strategies, all of which employed statins initially before adding nonstatin agents if LDL-C levels remained higher than a predefined threshold (or if a 50 percent LDL-C reduction was not achieved). 

“Following this approach, we found that 69.3 percent of patients could achieve LDL-C levels of less than 70 mg/dL with statin initiation and/or uptitration only, and add-on ezetimibe could increase the percentage to 86 percent. Adding a PCSK9 inhibitor to therapy for the remaining 14 percent still above the DLD-C threshold could result in more than 99 percent of the population with ASCVD having LDL level of less thatn 70 mg/dL,” they wrote.

They said that their findings indicate the existence of an opportunity to improve the attainment of goals for LDL-C with oral-only lipid lowering therapy, with 14 percent to 20.9 percent of the patients with ASCVD requiring an PCSK9 inhibitor.