Article Text
Abstract
Background and Importance LDL levels have been considered a surrogate marker of cardiovascular risk, which has taken on greater relevance in recent years.
Aim and Objectives To analyse the use and effectiveness of PCSK9 inhibitors (PCSK9i) in real world data
Material and Methods Retrospective study that includes patients treated >3 months with iPCSK9 from 1/1/2016 to 12/31/2022 in the Murcia Health Service. The parameters collected were age, sex, indication, LDL, iPCSK9 used, use of previous statins and mortality.
Data collection/analysis was carried out with Access® and PowerBi®. The drug consumption data was obtained from the Business Intelligence Portal and the clinical parameters of analysis/clinical history application
Results A total of 266 patients (61% men) with a median age of 58 years were included. The indication was, 59% familial hypercholesterolemia (FH) and 41% with established cardiovascular disease (CD).
The median LDL before treatment was 138 mg/dl, being 172 for FH and 117 for CD.
The 93% of patients had received a statin (73% high-intensity statin therapy: rosuvastatin ≥20 mg or atorvastatin 80 mg). The PCSK9 i drugs used were evolocumab in 58% of patients and alirocumab in 42%.
The median LDL at 3 months was 79 mg/ml and 68 mg/dl in the last year of tratament (reduction of 74 mg/dl compared to baseline) and was 92 for those on FH and 65 for patients with CD.
The 72% of patients reduced >30% their baseline LDL, 52% reached levels <70 mg/dl and 74.5% reached levels <100 mg/dl.
The percentage of patients who reached levels <100 mg/dl was higher in the CV group 78% compared to HF 62% (p<0.04).
Regarding (any cause) mortality, there was a total of 7 deaths (2.6%) distributed evenly in the two indications, with a probability of survival of 90% at 5 years.
Conclusion and Relevance The median LDL at the beginning of treatment was greater than 100 mg/dl, and 93% had received statins prior to treatment.
The effectiveness of the treatments regarding LDL reduction is similar to those published in pivotal clinical trials. The 5-year mortality published in this real-world data study is somewhat lower than that published in the FOURIER and ODYSSEY trials (2.6% vs 4.7% and 5%)
Conflict of Interest No conflict of interest.