Purpose: Inclisiran has demonstrated effective lipid-lowering effects when combined with statins; however, the effects of inclisiran monotherapy on low-density lipoprotein (LDL) in patients with a history of atherosclerotic cardiovascular disease have not been thoroughly evaluated in a real-world setting. Additionally, data to support that inclisiran reduces the risk of major adverse cardiac events (MACE) does not yet exist.
Methods: In an East Tennessee cardiology clinic, 68 patients were included for evaluation of inclisiran’s lipid-lowering effects. A retrospective chart review was completed for each patient to identify several key factors, including LDL levels, documentation of MACE, and documentation of adverse effects. REDCap™ and Microsoft Excel™ were utilized as the data collection software. Statistical analysis for the primary outcome included chi square; unpaired t-test was utilized for the secondary outcome.
Results: Forty-eight percent of patients had an LDL reduction of greater than or equal to fifty percent. The primary outcome was also evaluated in patients who were using inclisiran as monotherapy for LDL lowering, patients on high intensity statins in addition to inclisiran, and non-adherent patients, defined as at least 3 months past due for an inclisiran dose. Thirty-four patients were on inclisiran monotherapy, and fifteen of those patients achieved an LDL lowering of at least fifty percent. Nine patients were on inclisiran in addition to a high intensity statin, and five of those patients achieved an LDL lowering of at least fifty percent. Nineteen patients were non-adherent, and ten of those patients achieved an LDL lowering of at least fifty percent. Additionally, fourteen patients reached an LDL of twenty-five or less. There were three patients with documented occurrences of major adverse cardiac events and seven documented adverse events. The average reduction in LDL was forty-one percent.
Conclusions: Approximately half of the patients evaluated met an LDL reduction of at least fifty percent. There was no statistically significant difference in the primary outcome based on the subgroups evaluated. However, patients who were on high intensity statins in addition to inclisiran were more likely to achieve very low LDL levels. Results for patients who were non-adherent were similar to the total population.
