(72) Real World Effectiveness of Lipid-Lowering Medication in Denmark

Publication Number: 746

Background: Atherosclerotic cardiovascular disease (ASCVD) is the leading cause of death in the Western world. Clinical guidelines for treatment of patients with elevated cardiovascular disease risk is to reduce low density lipoprotein cholesterol level (LDL-C), a measure that is strongly associated with ASCVD risk, but there is a need for real-world evidence on the effectiveness of cholesterol lowering medication. LDL-C treatment goal is individualized according to total cardiovascular risk and includes a reduction in LDL-C of at least 50%.

Objectives: The study aim was to describe the effectiveness of statin, ezetimibe, fibrates, bile acid sequestrants, and PCSK9 inhibitors in lowering LDL-C in patients with familial hypercholesterolemia (FH), ASCVD, or atherosclerotic cardiovascular disease risk equivalent (ASCVD-RE) in Denmark.

Methods: This nationwide register-based study included all incident FH, ASCVD, or ASCVD-RE patients in 2015-2020 initiating cholesterol lowering medication. The number and proportion of patients achieving at least 50% reduction were quantified after 12 months of follow-up. Baseline LDL-C was measured between 6 months prior to two days after treatment initiation, while the post treatment LDL-C was measured between 3-12 months after initiation.

Results: We identified 123,638 individuals with FH, ASCVD, or ASCVD-RE who initiated cholesterol lowering medication, had 12 months of follow up, and LDL-C measured both before and after treatment initiation. Of the 118,729 who started statin treatment, 38,059 (32%) achieved at least 50% reduction in LDL-C (mean (SD) LDL-C at baseline: 3.4 (1.8) mmol/L). For patients initiating monotherapy, the proportion of patients achieving at least 50% reduction in LDL-C was even lower for most of the remaining drugs; ezetimibe (n=2,013): 12% (mean (SD) LDL-C at baseline: 4.3 (1.5) mmol/L), fibrates (n=486): 12% (mean (SD) LDL-C at baseline: 4.2 (1.7) mmol/L), bile acid sequestrants (n=176): 10% (mean (SD) LDL-C at baseline: 3.6 (2.4) mmol/L), PCSK9 inhibitors (n=42): ): 36% (mean (SD) LDL-C at baseline: 4.6 (1.9) mmol/L). For patients on combination therapy, combination of statin + ezetimibe (n=1,909): 21% (mean (SD) LDL-C at baseline: 3.3 (1.7) nmol/L), and combination statin + fibrates (n=238): 15% (mean (SD) LDL-C at baseline: 3.2 (1.8) nmol/L).

Conclusions: In a population of FH, ASCVD, or ASCVD-RE patients overall, 32% reached at least 50% reduction in LDL-C in the year following initiation of cholesterol lowering medication.