Real-world utilization of pharmacotherapy with new evidence-based cardiovascular indications in an academic preventive cardiology practice

OBJECTIVE: To determine the real-world use of pharmacotherapy with new evidence-based cardiovascular indications in an academic Preventive Cardiology Clinic. METHODS: A retrospective study of patients seen in our Center for Preventive Cardiology (CPC) and who received a new prescription, according to Food and Drug Administration (FDA) approved indications, for one of the following pharmacotherapies with new evidence-based cardiovascular indications from May 2019 to May 2020: proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i), eicosapentaenoic acid (EPA), sodium-glucose cotransporter 2 inhibitors (SGLT2i), and glucagon-like peptide-1 receptor agonists (GLP-1 RA). Treatment endpoints were prescription patterns, medication access, patient out-of-pocket expenses, medication tolerability, and clinical cardiovascular events while on these therapies. RESULTS: Of the 2390 patients seen in our CPC clinic over the observation period, 532 (22.3%) had already started and 291 (12.2%) were newly initiated on pharmacotherapy with new evidence-based cardiovascular indications with a median treatment duration of 9.1 months. Of these, 291 patients (for a total of 320 separate drug orders) – 93 (29.1%) were prescribed PCSK9i, 131 (40.9%) EPA, 46 (14.4%) SGLT2i, and 50 (15.6%) GLP-1 RA. Nearly 80% of cases required some form of provider intervention post-prescription (authorization, appeal, financial assistance, and/or side effect management). A total of 70% of adult patients with type 2 diabetes on metformin and with an HgbA1C >7% were treated with a SGLT2i and/or GLP-1 RA – either initiated prior to or during the study period. Median monthly drug cost for the total cohort was reduced from $595.00 pre-insurance approval to $70.50 post-insurance approval, to $7.00 post-financial assistance intervention. The medications were well tolerated with any side effect occurring in 28.3%, and discontinuation due to side effects in 5.8% of cases. Clinical cardiovascular events occurred in 2.7%, of which 1.9% was due to ASCVD and 0.8% to hospitalization for heart failure. Differences in medication access, cost, tolerability and clinical cardiovascular events varied widely between the medication classes. CONCLUSIONS: Initiation and management of pharmacotherapy with new evidence-based cardiovascular indications in a real-world setting requires substantial provider intervention, a workflow amenable to a multi-disciplinary approach which allows for high rates of medication access and cost minimization, and low rates of medication side effects and clinical cardiovascular events.