Clinical Data The study included 779 high cardiovascular risk patients taking maximally tolerated statins who required additional LDL-C lowering. The study achieved its efficacy endpoints and other key measures at 12 weeks, including:

• On-treatment LDL-C lowering of an additional 18 percent (vs. placebo, p<0.001), and in the intent to treat analysis, LDL-C lowering of an additional 17 percent (p<0.001)
• Reduction of 19 percent in high-sensitivity C-reactive protein (hsCRP), an important marker of the underlying inflammation associated with cardiovascular disease
• Reduction in hemoglobin A1c (HbA1c) of 0.21% vs. placebo in patients with diabetes

Safety and Tolerability of Bempedoic Acid Over 52 WeeksIn this 52-week study, adjudicated major adverse cardiovascular events (MACE) in the bempedoic acid arm as compared to placebo were:

• 3-component MACE: 2.7 percent for bempedoic acid compared to 4.7 percent for placebo
• 4-component MACE: 5.7 percent for bempedoic acid compared to 7.8 percent for placebo
• 5-component MACE: 6.1 percent for bempedoic acid compared to 8.2 percent for placebo

In this study, bempedoic acid was observed to be safe and well-tolerated. The results showed no clinically relevant differences between the bempedoic acid and placebo treatment groups in the occurrence of:

• Adverse events (AEs) with 70 percent and 71 percent, respectively;
• Serious adverse events (SAEs) with 20 percent and 19 percent, respectively;
• Discontinuations due to AEs with 11 percent and 9 percent, respectively;
• Fatal adverse events with 1.1 percent and 0.8 percent, respectively. No fatal adverse events were determined to be related to study medication.  CV deaths were balanced between the study arms (0.8% vs. 0.8%). The bempedoic acid arm included a case of gas poisoning and a case of sepsis as a complication of planned abdominal surgery. No fatal AEs due to neoplasms.