New study to evaluate lipid management in clinical practice

June 25, 2015

As lipid management in the United States under goes transition in response to new guideline recommendations and expanding lipid-lowering therapy options, the Duke Clinical Research Institute (DCRI) 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.

As lipid management in the United States under goes transition in response to new guideline recommendations and expanding lipid-lowering therapy options, the Duke Clinical Research Institute (DCRI) 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.

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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.

Dr WangIn 2013, the American Heart Association and American College of Cardiology guidelines for lipid management changed drastically from prior guidelines, broadening candidacy for statin medications, recommending statin treatment based on patients’ predicted 10-year atherosclerotic cardiovascular disease (ASCVD) risk and de-emphasizing LDL-C targets, according to Tracy Wang, MD, MHS, MSc, principal investigator of the PALM study and director of the Duke Center for Educational Excellence.

“However, the degree to which these new guidelines have been adopted by clinicians in community practice is unknown,” said Dr Wang. “The PALM registry was designed to assess patterns of lipid lowering therapy use among a nationally representative cohort of community clinics, determine consistency of treatment with current lipid guidelines, and assess provider and patient perspectives on lipid management and CV risk reduction.”

The ultimate goal here is to optimize CV risk prevention among contemporary adults, according to Dr Wang.

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“These are patients who receive care across primary care, family medicine, cardiology, and lipid clinics, as well as other specialty clinics,” she said. “The goal of this registry is to reflect treatment patterns in these clinics, identify potential gaps, and understand patient and provider barriers to optimal medication use.”

Dr Wang expects that current practice to differ significantly from guidelines-recommended care.

“We expect that provider report of their practices may differ from actual patterns of care observed,” she said. “We expect that patients will report barriers to optimal lipid management largely related to a different understanding of CV risk reduction goals compared with providers.

“Cardiovascular risk prevention can be challenging because of the broad population of patients we need to reach, who have not just differing clinical needs but also different perception and understanding of CV risk prevention goals,” Dr Wang added. “Their care is made more complex by changing guideline recommendation with varying provider buy-in. PALM Registry will be critical to sorting out these issues.”

The study is sponsored by Regeneron Pharmaceuticals, Inc. and Sanofi.

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