RESUMO
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.
RESUMO
Heart failure with reduced ejection fraction (HFrEF) is a debilitating disease that is associated with substantial morbidity, mortality, and societal costs. The past three decades have brought about significant advancements in the pharmacologic management of HFrEF, and a corresponding reduction in morbidity and mortality. However, the progress to improve clinical outcomes in real-world settings has stalled in recent years, largely due to underutilization of guideline directed medical therapies (GDMT). The discovery of significant cardio-renal protection from sodium-glucose co-transporter 2 inhibitors (SGLT2i) has ushered in a new treatment paradigm for HFrEF management with SGLT2i therapy becoming an essential component of GDMT. Our Preventive Cardiology and Heart Failure services have established an innovative, multi-disciplinary, collaborative protocol to optimize management of cardiovascular risk factors and facilitation SGLT2i use in patients with HFrEF. The goal of this collaboration is to enhance utilization and safety of SGLT2i for HFrEF management by circumventing medication access issues, the major obstacle to therapy initiation. Within this protocol, our heart failure providers identify patients for the addition of SGLT2i to a background of heart failure GDMT. The patient is then referred to preventive cardiology where the team performs a comprehensive cardiovascular risk assessment, optimizes cardiovascular risk factors, and initiates SGLT2i with an emphasis on medication access, cost minimization, and mitigation of potential side effects. The heart failure team assumes responsibility for modification of heart failure-based therapies, and the preventive team manages diabetes, lipid, and metabolic-based therapies. The patient is followed by both cardiology services in a structured fashion, comparing outcome measures at regular intervals and utilizing our patient registry and bio-repository. This clinical practice statement provides a detailed evidentiary review on the cardiovascular and renal benefits of SGLT2i, outlines the rational for creation of a collaborative protocol, details a structured program that may serve as a template for enhanced heart failure management in other health systems, and addresses challenges encountered and recommendations for use.
