Bempedoic acid (NEXLETOL) showed promise lowering low-density lipoprotein cholesterol (LDL-C) when compared to placebo in new data presented during the American Heart Association Scientific Sessions 2020 (AHA 2020).
Esperion announced the positive results from pooled data from 4 phase 3 trials presented during the annual meeting showing the treatment resulted in significant lowering of LDL-C by week 12 in specific subgroups, including patients who cannot tolerate statins and females.
The data comes from a subgroup of more than 580 patients not receiving any dose of a statin. The researchers found this patient population showed a significant mean reduction of 26.5% (P <0.001) in LDL-C by week 12 with the bempedoic acid when compared to placebo.
The study drug was also generally well tolerated, with treatment-emergent adverse events comparable across both arms of the trials.
In another poster presented at AHA 2020, the investigators found the treatment significantly lowered LDL-C at week 12 in both sexes compared to placebo for a pooled population of more than 3600 patients across 4 studies. LDL-C lowering was numerically greater in females when compared to males across both pools of the study.
The placebo-corrected mean reduction found in the data was 27.7% for females and 22.1% for men (interaction P = 0.079) for the statin-intolerant pool. This decreased to 21.2% and 17.4% in males (interaction P = 0.044) in the pool of patients with atherosclerotic cardiovascular disease (ASVCD) and/or heterozygous familial hypercholesterolemia (HeFH) who were receiving background maximally tolerated statin.
Bempedoic acid was generally well-tolerated by both sexes in the study.
“Women are half of the population, and nearly 10 million patients in the U.S. with high LDL-C levels are not on statins due to tolerability issues, 3 yet these groups have been underrepresented in previous medical research,4” Ashley Hall, Chief Development Officer for Esperion, said in a statement. “Our goal at Esperion is lipid management for everybody, and these analyses show significant LDL-C efficacy and acceptable safety for NEXLETOL in these subgroups.”
Earlier this year, the US Food and Drug Administration (FDA) was approved as the first oral, once-daily, non-statin LDL-C lowering medicine available to indicated patients in nearly 2 decades.
The FDA approval was supported by a global phase 3 LDL-C lowering program conducted in more than 3000 patients with ASCVD and/or HeFH, where bempedoic acid provided an average of 18% placebo-corrected LDL-C lowering when used with moderate or high-intensity statins.
The most common adverse reactions were upper respiratory tract infection, muscle spasms, hyperuricemia, back pain, abdominal pain or discomfort, bronchitis, pain in extremity, anemia and elevated liver enzymes.
The treatment is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with HeFH or established ASCVD who require additional lowering of LDL-C.
The researchers have yet to determine the effect of bempedoic acid on cardiovascular morbidity and mortality.