Physicians' Academy for Cardiovascular Education

Combination pill with inhibitors of cholesterol synthesis and absorption met primary endpoint

News - Sep. 3, 2018

Positive top-line results from the pivotal Phase 3 bempedoic acid/ezetimibe combination pill study (1002-053) have been announced. This trial was a randomized, double-blind, parallel group study conducted to evaluate the efficacy and safety of the bempedoic acid 180 mg / ezetimibe 10 mg combination pill compared to bempedoic acid, ezetimibe or placebo in high-risk patients with ASCVD and/or heterozygous familial hypercholesterolemia or with multiple risk factors for ASCVD being treated with maximally tolerated statins

Bempedoic acid inhibits ATP Citrate Lyase (ACL) and thereby reduces cholesterol biosynthesis and lowers LDL-C by up-regulating the LDL receptor. The combined effects of the complementary mechanisms of action of inhibition of cholesterol synthesis (bempedoic acid) and inhibition of cholesterol absorption (ezetimibe), were evaluated as a non-statin, orally available, once-daily, LDL-C lowering therapy.

The 12-week, pivotal Phase 3 randomized, double-blind, parallel group, multicenter study included 382 high-risk patients taking maximally tolerated statins who required additional LDL-C lowering and met its key efficacy endpoints, including:

In 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:

Source: press release Esperion, August 27, 2018