🆕 approach to lowering cholesterol with the use of bempedoic acid brought about a significant reduction in cardiovascular events in patients intolerant to statins in the large phase 3 placebo-controlled CLEAR Outcomes trial. WCCardio ACC23 MedTwitter
Nissen pointed out that while in the current study bempedoic acid was studied as monotherapy, he believes the drug will mainly be used in clinical practice in combination with ezetimibe, a combination shown to reduce LDL by 38%."I think this is how it will be used in clinical practice. So, we can get an almost 40% LDL reduction — that's about the same as 40 mg simvastatin or 20 mg atorvastatin — without giving a statin.
The mean LDL cholesterol level at baseline was 139 mg/dL in both groups, and after 6 months, the reduction in the level was greater with bempedoic acid than with placebo by 29.2 mg/dL .After a median duration of follow-up of 40.6 months, the incidence of a primary end point was significantly lower with bempedoic acid than with placebo .
Subgroup analysis showed similar results across all groups and no difference in treatment effect between men and women. "Whether real or perceived, statin intolerance remains a vexing clinical problem that can prevent patients who are guideline-eligible for statin treatment from reaching LDL cholesterol levels associated with clinical benefits. Accordingly, alternative non-statin therapies are needed to manage the LDL cholesterol level in these patients," they write.
O'Donoghue concluded that the study showed"compelling findings," and the event reduction was in line with what would be expected from the LDL cholesterol reduction, further supporting the LDL hypothesis. On the observation that bempedoic acid had no observed effect on mortality, he notes that"Many individual trials of statins have also not shown an effect of the agent on mortality; it was only through the meta-analysis of multiple clinical trials that the effects of statins on mortality became clear."
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