Additional Relevant Details The study included 382 high-risk patients taking maximally tolerated statins who required additional LDL-C lowering and met its key efficacy endpoints, including:

• On-treatment analysis LDL-C lowering of 35 percent for the combination pill at 12 weeks (p<0.001) compared to 3 percent for placebo, 24 percent for ezetimibe 10 mg (EZE) and 20 percent for bempedoic acid 180 mg (BA);
• In the intent to treat analysis, LDL-C lowering was 32 percent for the combination pill compared to 3 percent for placebo (p<0.001), 21 percent for EZE (p<0.001) and 18 percent for BA (p<0.001);
• Reduction of 34 percent for the FDC in high-sensitivity C-reactive protein (hsCRP), an important marker of the underlying inflammation associated with cardiovascular disease, compared with an increase in placebo of 4 percent and reductions of 20 percent for BA and 9 percent for EZE.
• In a post-hoc analysis of patients considered statin intolerant, the combination pill LDL-C lowering was 43 percent in the on-treatment analysis compared to a one percent increase for placebo;
  
  Safety and Tolerability of Combination Pill Over 12 WeeksIn this 12-week study, the bempedoic acid / ezetimibe combo pill was observed to be safe and well-tolerated. The results showed no clinical differences between the FDC, BA, EZE and placebo patient groups in the occurrence of:
  • Serious adverse events (SAEs) with 8 percent, 6 percent, 9 percent and 2 percent, respectively. No SAEs were considered to be related to study medication;  
  • Discontinuations due to AEs with 7 percent, 8 percent, 9 percent, and 4 percent, respectively;  
  • No elevations in liver function tests (ALT/AST) of greater than three times the upper limit of normal, repeated and confirmed were observed.