Comparison of an "inclisiran first" approach with standard care for patients diagnosed with atherosclerotic cardiovascular disease
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A recent study showed that the use of an "inclisiran first" approach resulted in a more significant reduction in low-density lipoprotein cholesterol (LDL-C) levels when compared to standard care, without negatively impacting the use of statins or giving rise to any additional safety concerns. This research findings were published in the Journal of the American College of Cardiology.
The VICTORION-INITIATE trial involved 450 patients who were randomly assigned in a 1:1 ratio to receive either inclisiran (284 mg at days 0, 90, and 270) along with standard care (lipid management determined by the treating physician) or standard care alone. The primary endpoints of the study assessed the percentage change in LDL-C levels from the baseline and the rates of statin discontinuation.
The "inclisiran first" strategy resulted in significantly larger reductions in LDL-C levels from baseline to day 330 compared to standard care (60.0% vs. 7.0%; P < 0.001). The discontinuation rates of statins with the "inclisiran first" approach (6.0%) were found to be noninferior to standard care (16.7%). A higher proportion of patients in the "inclisiran first" group achieved their LDL-C goals compared to standard care (<70 mg/dL: 81.8% vs. 22.2%; <55 mg/dL: 71.6% vs. 8.9%; P < 0.001). Rates of treatment-emergent adverse events (TEAE) and serious TEAE were comparable between the two treatment strategies (62.8% vs. 53.7% and 11.5% vs. 13.4%, respectively).
The above study demonstrated that adopting an "inclisiran first" strategy led to a greater decrease in LDL-C levels compared to conventional treatment, while maintaining the use of statins and without posing any additional safety issues.