In the Journals

Bempedoic acid/ezetimibe combination lowers LDL, CRP

Christie M. Ballantyne

Compared with placebo or either agent alone, a combination of bempedoic acid and ezetimibe lowered LDL to a greater degree, researchers reported.

The researchers also wrote that the combination was effective at reducing high-sensitivity C-reactive protein.

“The results of this study show that the bempedoic acid/ezetimibe [fixed-dose combination] tablet provided significant additional LDL lowering and [high-sensitivity] CRP reductions when added to maximally tolerated statin therapy,” Christie M. Ballantyne MD, professor of medicine at Baylor College of Medicine, said in a press release. “For patients who are not at their goal levels despite currently accessible therapies, the LDL lowering and [high-sensitivity] CRP reductions seen with the bempedoic acid/ezetimibe [fixed-dose combination] tablet support that this could be a very important treatment option.”

The researchers randomly assigned 301 patients (mean baseline LDL, 3.87 mmol/L or 149.8 mg/dL) with atherosclerotic CVD, heterozygous familial hypercholesterolemia or multiple CVD risk factors to the fixed-dose combination tablet of bempedoic acid (Esperion Therapeutics) 180 mg/ezetimibe 10 mg, bempedoic acid 180 mg alone, ezetimibe 10 mg alone or placebo.

The primary endpoint of percentage change in LDL between baseline and 12 weeks was significantly lower in the bempedoic acid/ezetimibe group than in the other groups, according to the researchers.

Patients in the bempedoic acid/ezetimibe group had a decrease in LDL of 36.2% vs. an increase of 1.8% in the placebo group, a decrease of 23.2% in the ezetimibe group and a decrease of 17.2% in the bempedoic acid group (P < .001 for all).

Among patients in the bempedoic acid/ezetimibe group, LDL lowering was consistent regardless of statin therapy, the researchers wrote.

In addition, the bempedoic acid/ezetimibe group had a 35% reduction in high-sensitivity CRP and a similar safety profile compared with the other groups.

“With its liver-specific mode of action, bempedoic acid avoids the debilitating muscle-related side effects that are often associated with statins and could serve as a valuable complementary treatment option to hypercholesterolemia patients who are not reaching their goals with existing treatment options,” Wolfgang Zierhut, MD, head of the antithrombotic and cardiovascular medical affairs department at Daiichi Sankyo Europe, which has a license to market bempedoic acid and bempedoic acid/ezetimibe in Europe, said in the release.

Bempedoic acid and bempedoic acid/ezetimibe are currently undergoing the regulatory approval process in the United States and Europe and are not yet commercially available. – by Erik Swain

Disclosures: Ballantyne reports he has consulted for Abbott Diagnostics, Akcea, Amarin, Amgen, AstraZeneca, Boehringer Ingelheim, Denka Seiken, Esperion, Intercept, Janssen, Matinas BioPharma Inc., Merck, Novartis, Novo Nordisk, Regeneron, Roche Diagnostics and Sanofi-Synthelabo. Zierhut is an employee of Daiichi Sankyo. Please see the study for all other authors’ relevant financial disclosures.

Christie M. Ballantyne

Compared with placebo or either agent alone, a combination of bempedoic acid and ezetimibe lowered LDL to a greater degree, researchers reported.

The researchers also wrote that the combination was effective at reducing high-sensitivity C-reactive protein.

“The results of this study show that the bempedoic acid/ezetimibe [fixed-dose combination] tablet provided significant additional LDL lowering and [high-sensitivity] CRP reductions when added to maximally tolerated statin therapy,” Christie M. Ballantyne MD, professor of medicine at Baylor College of Medicine, said in a press release. “For patients who are not at their goal levels despite currently accessible therapies, the LDL lowering and [high-sensitivity] CRP reductions seen with the bempedoic acid/ezetimibe [fixed-dose combination] tablet support that this could be a very important treatment option.”

The researchers randomly assigned 301 patients (mean baseline LDL, 3.87 mmol/L or 149.8 mg/dL) with atherosclerotic CVD, heterozygous familial hypercholesterolemia or multiple CVD risk factors to the fixed-dose combination tablet of bempedoic acid (Esperion Therapeutics) 180 mg/ezetimibe 10 mg, bempedoic acid 180 mg alone, ezetimibe 10 mg alone or placebo.

The primary endpoint of percentage change in LDL between baseline and 12 weeks was significantly lower in the bempedoic acid/ezetimibe group than in the other groups, according to the researchers.

Patients in the bempedoic acid/ezetimibe group had a decrease in LDL of 36.2% vs. an increase of 1.8% in the placebo group, a decrease of 23.2% in the ezetimibe group and a decrease of 17.2% in the bempedoic acid group (P < .001 for all).

Among patients in the bempedoic acid/ezetimibe group, LDL lowering was consistent regardless of statin therapy, the researchers wrote.

In addition, the bempedoic acid/ezetimibe group had a 35% reduction in high-sensitivity CRP and a similar safety profile compared with the other groups.

“With its liver-specific mode of action, bempedoic acid avoids the debilitating muscle-related side effects that are often associated with statins and could serve as a valuable complementary treatment option to hypercholesterolemia patients who are not reaching their goals with existing treatment options,” Wolfgang Zierhut, MD, head of the antithrombotic and cardiovascular medical affairs department at Daiichi Sankyo Europe, which has a license to market bempedoic acid and bempedoic acid/ezetimibe in Europe, said in the release.

Bempedoic acid and bempedoic acid/ezetimibe are currently undergoing the regulatory approval process in the United States and Europe and are not yet commercially available. – by Erik Swain

Disclosures: Ballantyne reports he has consulted for Abbott Diagnostics, Akcea, Amarin, Amgen, AstraZeneca, Boehringer Ingelheim, Denka Seiken, Esperion, Intercept, Janssen, Matinas BioPharma Inc., Merck, Novartis, Novo Nordisk, Regeneron, Roche Diagnostics and Sanofi-Synthelabo. Zierhut is an employee of Daiichi Sankyo. Please see the study for all other authors’ relevant financial disclosures.