At a time when lipid management in the United States is undergoing transition in response to new guideline recommendations and expanding lipid-lowering therapy options, the Duke Clinical Research Institute (DCRI) today announced a new study to better understand contemporary lipid management as well as the beliefs and attitudes of patient and providers regarding cholesterol, cardiovascular risk assessment, and options for lipid treatments. The study is sponsored by Regeneron Pharmaceuticals, Inc. and Sanofi.
New guidelines for the treatment of hyperlipidemia, or elevated levels of cholesterol in the blood, released in 2013 by the American Heart Association and American College of Cardiology had several major changes from previous guidelines, including an emphasis on cardiovascular risk assessment to determine who is eligible for treatment, a push for use of high-dose statins rather than a treat-to-target strategy, and an emphasis on the importance of patient engagement in treatment decisions.
The DCRI's Patient and Provider Assessment of Lipid Management (PALM) study will enroll approximately 7,500 patients in the community practice setting from 175 sites across the United States with cardiovascular risk factors warranting consideration of lipid-lowering therapies, as well as patients already on statin therapy.
"Hyperlipidemia has long been recognized as a risk factor for the development of cardiovascular disease, yet current treatment guidelines vary and physician adherence to guidelines in practice has traditionally been poor," said Eric Peterson, MD, MPH, executive director of the DCRI and study chair for PALM. "The PALM study is designed to deliver insights on what are current patterns of lipid therapies and what clinicians will be prescribing in the future. Importantly, we will be collecting the 'why' factor — why clinicians are ordering therapy or not, and why patients are electing to fill their prescriptions or not."
"Gaining a better understanding of the use of lipid-lowering therapies will allow for design of targeted interventions to improve lipid management," said Tracy Wang, MD, MHS, MSc, principal investigator of the PALM study and director of the Duke Center for Educational Excellence. "A cornerstone of DCRI's mission is to develop and share knowledge to improve clinical practice. For this study we'll be doing that and more with a mobile trial tool that innovates trials and patient recruitment practices and brings a new level of efficiency and security to patient recruitment."
The DCRI has developed a digital patient recruitment application that allows physicians to use a tablet device for enrolling patients during the patient visit, eliminating paper entries and enabling secure and higher-quality data collection. The application provides patients with the option of video informed consent, designed to promote understanding of and interest in the study. Additionally, the digital platform permits adaptive survey designs to reduce data collection burden and permit embedded randomization.
Despite the widespread availability of lipid-lowering therapies, the rate of elevated low-density lipoprotein cholesterol (LDL-C) among adults remains high in the United States. A DCRI study published in the April 10, 2014 issue of the New England Journal of Medicine found that high LDL-C affects 71 million adults (33.5 percent of the population), with fewer than half on treatment. The PALM registry will:
•Describe lipid-lowering therapy use among a contemporary, nationally representative, community-based sample of adult patients receiving primary and subspecialty care in the United States.
•Evaluate the proportion of patients whose treatment is consistent with the various lipid guideline recommendations (both risk- and goal-based).
•Identify patient- and provider-reported factors affecting use of lipid-lowering therapies.
•Assess patient and provider knowledge and perception of cardiovascular risk reduction goals and lipid management options.
•Evaluate frequency and management of reported intolerance to statins.
Source: Duke Clinical Research Institute (DCRI)