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On June 16, 2023, we reported on a study presented at ENDO 2023, the Endocrine Society's annual meeting.
Researchers presented an analysis of data from the landmark CLEAR Outcomes trial, which enrolled 13 970 statin-intolerant patients who had, or were at high risk for, cardiovascular (CV) disease. The current analysis examined whether the relationship between LDL-C reduction and the magnitude of the CV events seen in CLEAR Outcomes with bempedoic acid were comparable to levels of the same outcomes for statin therapy.
For their comparison, investigators referred to findings from a landmark meta-analysis of statin trials by the Cholesterol Treatment Trialists (CTT) Collaboration and to the methodology used to calculate the CV event outcomes. The CTT meta-analysis showed that each 1 mmol/L (39 mg/dL) reduction in LDL-C was associated with a 22% reduction in major vascular events (MVE). The CTT analysis also found that the benefit increased with cumulative treatment.
Authors thus used the CTT methodology to assess whether the effects of bempedoic acid on reduction of risk for a composite endpoint of CV outcomes are similar to that of statins, per unit decrease in LDL-C after 12 months of treatment.
According to the study abstract, participants assigned to treatment with bempedoic acid achieved a placebo-corrected lowering of LDL-C of 0.58 mmol/L (22.43 mg/dL) at month 12, with an associated 15% reduction (HR 0.85; 95%CI 0.77-0.94) in the risk of the CTT MVE endpoint.
When normalized to a 1.0 mmol/L LDL-C reduction as was performed in the CTT, the CV risk reduction with bempedoic acid was comparable to the normalized risk reduction with statins observed in the CTT meta-analyses of 22% (risk ratio 0.78, 95% CI 0.76- 0.80]. The beneficial effect of bempedoic acid on MVE reduction generally improved over time, similar to what was observed in statin cardiovascular outcomes trials. Specifically, the cumulative normalized hazard ratio for major CV events improved from 0.77 at year 1 to 0.72 by year 4 of treatment with bempedoic acid.