A study on a new class of cholesterol-lowering drugs led by Rhonda Cooper-DeHoff, Pharm.D., M.S., FAHA, FACC, an associate professor of pharmacotherapy and translational research in the University of Florida College of Pharmacy, was selected as a Late Breaking Clinical Trial presentation at the American Heart Association 2018 Scientific Sessions in Chicago. Cooper-DeHoff reported on her successful use of real-world electronic health record data from 18 health systems to identify over 3.5 million adults who met criteria for the study on PCSK9 inhibitors, a new class of cholesterol-lowering drugs and other lipid-lowering medications.
PCSK9 inhibitors effectively lower low-density lipoprotein cholesterol, or LDL-C, and have been shown to reduce cardiovascular outcomes in high-risk patients. They are often prescribed as a secondary medication for patients who are intolerant to traditional high-intensity statins, which are recommended by the American College of Cardiology and the American Heart Association as a first-line therapy for cardiovascular disease. The U.S. Food and Drug Administration has approved two PCSK9 inhibitors that reduce LDL-C levels 50-60 percent beyond statin therapy alone.
Using data from the Patient Centered Clinical Research Network, or PCORNet, Cooper-DeHoff and her research team found less than one percent of patients in the study were prescribed PCSK9 inhibitors early in the approval period. While overall use of a PCSK9 inhibitor was low, Cooper-DeHoff observed an increase in PCSK9 inhibitor use over time for patients with coronary artery disease or coronary heart disease.
“Despite the evidence of the effectiveness of PCSK9 inhibitors, their use is limited by the high cost of treatment, which until very recently was estimated at $14,000 per year,” Cooper-DeHoff said. “A large number of cardiovascular events may be preventable with improved access to PCSK9 inhibitors and lower costs. Recently, a drug manufacturer for a PCSK9 inhibitor announced that the cost would be cut by more than half, which will likely improve access to this important lipid-lowering therapy. ”
Cooper-DeHoff is the lead investigator of the hypertension/cardiovascular disease working group within the OneFlorida Clinical Research Consortium, and she is principal investigator for the Patient-Centered Outcomes Research Institute, or PCORI, Cardiovascular Health Collaborative Research Group. She serves as associate director for the Center for Pharmacogenomics and Precision Medicine.