Bempedoic acid shows long-term efficacy, safety

In patients with atherosclerotic cardiovascular disease, continued treatment with bempedoic acid for up to 2.5 years effectively keeps levels of low-density lipoprotein cholesterol (LDL-C) low, while also being generally well-tolerated, according to the results of a phase 3, open-label extension (OLE) study.

A total of 1,462 patients participated in the present analysis, of whom 970 were given bempedoic acid in the parent study, while the remaining 492 were given placebo. During the OLE, those on bempedoic acid continued medication until ≤130 weeks, while placebo patients initiated bempedoic acid, with medication duration lasting for ≤78 weeks.

Efficacy was measured as the percent-change in LDL-C levels from parent-study baseline; the impact of bempedoic acid on other lipid parameters and high-sensitivity C-reactive protein (hsCRP) was also assessed. Safety was measured according to treatment-emergent adverse events (TEAEs), AEs of special interest, and laboratory abnormalities.

Bempedoic acid induced a consistent decline in LDL-C. For instance, those who were assigned to bempedoic acid during the parent study saw an average percent decrease of 14.2 percent from baseline until the end of the OLE. Meanwhile, patients who were initially assigned to placebo but switched to bempedoic acid showed a 15.0-percent decline in LDL-C by the end of OLE. In both groups, such reductions were stable throughout OLE.

In terms of tolerability, the researchers reported a similar rate of TEAEs in those who had been treated with bempedoic acid for ≤130 and ≤78 weeks (78 percent in both groups). Moreover, TEAEs leading to the discontinuation of treatment during OLE, regardless of causality, occurred in only 7.8 percent of patients.