Two drugs used to lower LDL cholesterol have been proven to be even more effective when combined in a fixed dosage. Bempedoic acid and ezetimibe were shown to have a complementary effect when used to treat those with hypercholesterolemia who are on statins but still at high risk of cardiovascular disease.
The findings, presented at 87th Annual Congress of the European Atherosclerosis Society, showed that these results also were found in patients who were not on statins due to a statin intolerance.
“Lipid-lowering drugs have been used for decades with new, more effective therapies being developed; however, many people fail to reach healthy levels of LDL cholesterol and are still at risk of heart attack or stroke,” said , professor of medicine and chief of the sections of cardiology and cardiovascular research at Baylor College of Medicine and lead author on the study. “Available therapies are limited for some, such as those who are intolerant of statins, which is why more options are needed.”
Researchers followed more than 200 patients for 12 weeks. Those taking part had either atherosclerotic cardiovascular disease, familial hypercholesterolemia, or both, or multiple cardiovascular risk factors which can included diabetes, smoking, hypertension, low HDL cholesterol, or a coronary calcium score above the 95th percentile. Participants were given either an oral, once-daily treatment of 180mg of bempedoic acid and 10 mg of ezetimibe, each treatment alone, or placebo.
Bempodoic acid works by suppressing cholesterol synthesis, resulting in lowering LDL cholesterol levels in the blood stream. Ezetimibe is an inhibitor of intestinal cholesterol absorption, reducing the amount of cholesterol the body absorbs.
“The combination of the two, working together, lowered LDL cholesterol across all subgroups in the study whether they were on statins or not,” Ballantyne said. “These findings support the idea that this combination could be used in a diverse population regardless of statin use.”
Treatment with the combination pill led to a reduction in LDL cholesterol of 38 percent compared to placebo.
Ballantyne also said that this study was designed to assess the efficacy and safety of the combination pill in order to support past studies with similar findings. These results show that this combination was safe and well tolerated by participants. Further studies are underway to evaluate how this treatment specifically affects cardiovascular disease outcomes.
Others who took part in this study include Ulrich Laufs, Universitätsklinikum Leipzig; Kausik K. Ray, Imperial College London; Lawrence A. Leiter, University of Toronto; Harold E. Bays, Louisville Metabolic and Atherosclerosis Research Center; Anne C. Goldberg, Washington University; Erik S.G. Stroes, Academic Medical Centre, Amsterdam; Diane MacDougall and Xin Zhao, Esperion Therapeutics, Inc.; Alberico L. Catapano, University of Milan and Multimedica IRCCS. Ballantyne also is the director of the Maria and Alando J. Ballantyne Atherosclerosis Clinical Research Laboratory at Baylor, director of the Center for Cardiovascular Disease Prevention at the Methodist DeBakey Heart Center and co-director of the Lipid Metabolism and Atherosclerosis Clinic at Houston Methodist. He also holds the J. S. Abercrombie Chair in Atherosclerosis and Lipoprotein Research at Baylor.
Funding for this study is by Esperion Therapeutics Inc.
