Esperion announced positive top-line results from the Phase 2 bempedoic acid / ezetimibe combination tablet study (1002-058). This was a randomized, double-blind, parallel group study assessing the efficacy and safety of the bempedoic acid / ezetimibe combination tablet compared to ezetimibe and placebo in 179 patients with both hypercholesterolemia and type 2 diabetes. Patients enrolled were on stable background diabetes medications and washed out of lipid modifying therapies.
The 12-week study met its primary endpoints as well as key secondary endpoints, including that the bempedoic acid / ezetimibe combination tablet:
- Significantly lowered LDL-C by 40 percent compared to placebo (p<0.001);
- Reduced high-sensitivity C-reactive protein (hsCRP), an important marker of inflammation associated with cardiovascular disease, by 25 percent (p<0.001);
- No worsening of glycemic control;
- Overall adverse events (AEs) comparable to placebo;
- Had no increase in muscle-related AEs, serious adverse events, discontinuations due to AEs or elevations in liver function tests (LFTs);
- Achieved LDL-C levels of <70 mg/dl and an LDL-C reduction of >50 percent in approximately 40 percent of patients.
“The LDL-C lowering and hsCRP reductions seen with the bempedoic acid / ezetimibe once-daily combination oral tablet, without worsening glycemic parameters, are very important to physicians like me who frequently manage patients with both hypercholesterolemia and type 2 diabetes. In addition, the substantial reductions in apolipoprotein B and non-HDL-C observed in this study may be particularly important for patients with hypercholesterolemia and type 2 diabetes,” said Dr. Harold Bays, Medical Director and President of the Louisville Metabolic and Atherosclerosis Research Center. “Patients benefit from having more therapeutic options, especially ones that improve multiple cardiovascular disease risk factors.”