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Bempedoic acid combinations show promise for LDL lowering
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A phase 2 study of bempedoic acid combined with ezetimibe plus atorvastatin showed LDL reduction, and an additional phase 2 study of bempedoic acid combined with a PCSK9 inhibitor has been initiated, according to press releases from Esperion Therapeutics.
The combination of bempedoic acid/ezetimibe plus atorvastatin reduced LDL cholesterol by 64% compared with placebo. In the treatment group, 95% of patients achieved at least 50% LDL reduction and 90% achieved LDL levels of less than 70 mg/dL.
The treatment group also had a 48% reduction in high-sensitivity C-reactive protein.
There were no reported adverse events.
“Patients in this study experienced nearly a 100 mg/dL drop in their LDL-C levels on the combo plus atorvastatin. These highly positive study results of the combination therapy demonstrate very robust and remarkably consistent LDL-C lowering with what appears to be optimal safety and tolerability,” Tim M. Mayleben, president and CEO of Esperion, said in the release.
Esperion is also launching a study of bempedoic acid combined with an injectable PCSK9 inhibitor, evolocumab (Repatha, Amgen), to assess the LDL lowering efficacy and safety.
The study is a randomized, double-blind, placebo-controlled trial of daily oral bempedoic acid (180 mg) and once-monthly evolocumab (420 mg). The study aims to enroll 50 patients across 20 sites in the U.S. and will continue for 8 weeks.
“Our goal remains to leverage the bempedoic acid franchise to provide physicians with the flexibility to utilize multiple convenient, cost-effective, once-daily, oral therapies to treat the vast majority of patients with elevated LDL-C,” Mayleben said.