Esperion announces results from Phase 2 study of bempedoic acid/ezetimibe combo
Esperion announced positive top-line results from the Phase 2 bempedoic acid / ezetimibe combination tablet study. 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; Reduced high-sensitivity C-reactive protein, an important marker of inflammation associated with cardiovascular disease, by 25 percent; No worsening of glycemic control; Overall adverse events comparable to placebo; Had no increase in muscle-related AEs, serious adverse events, discontinuations due to AEs or elevations in liver function tests; Achieved LDL-C levels of less than70 mg/dl and an LDL-C reduction of greater than50 percent in approximately 40 percent of patients. The results showed no clinical differences between the bempedoic acid / ezetimibe combination tablet, placebo, and ezetimibe patient groups in the occurrence of: Adverse events with 43 percent, 37 percent, and 30 percent, respectively; Serious adverse events with 0 percent, 2 percent, and 2 percent, respectively; Discontinuations due to AEs with 0 percent, 0 percent, and 2 percent, respectively; No elevations in liver function tests were observed.