Clinical Trial Results on Novel Nonstatins Agents.


Expert cardiologists discuss the recent clinical trials results of the CLEAR-OUTCOMES trial and thee sub analysis on the inflammatory marker hcCRP.


The experts discuss the CLEAR Outcomes trial results for the newer cholesterol-lowering agent bempedoic acid in statin-intolerant patients. This 14,000-patient trial included a mix of primary and secondary prevention patients and demonstrated a significant reduction in 3-point major adverse cardiovascular events (MACE). While LDL lowering was modest, the MACE reduction aligned with expectations based on the degree of LDL lowering. Bempedoic acid also reduced inflammation, measured by hsCRP, without increasing diabetes risk, unlike statins.

There was additional analysis showing more benefit in the 30% of trial subjects who were high-risk primary prevention patients. Notably, there was a reduction in all-cause mortality for bempedoic acid in these patients. This reinforces the concept of a continuum of residual risk, where apparently healthy people can still be at high latent cardiovascular risk in the absence of cholesterol lowering therapy.

Beyond LDL, the experts emphasize assessing residual inflammatory risk with hsCRP, residual thrombotic risk, residual cholesterol risk as measured by triglycerides for icosapent ethyl therapy, and emerging risk markers like Lp(a). They advocate a personalized approach to matching specific therapies to a patient's dominant driver of residual risk. This more holistic, multi-pathway framework for risk reduction stands to optimize outcomes compared to focusing on LDL alone.

This summary was AI-generated and edited for clarity and readability.

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