Significant mean reduction of 26.5% in LDL-C with bempedoic acid vs. placebo in pooled analysis of people who cannot tolerate statins1
Analysis by sex showed bempedoic acid significantly lowered LDL-C at week 12 in males and females* vs. placebo2
#ESPR "announced results of pooled data from four of the company’s Phase 3 trials were presented at the virtual American Heart Association Scientific Sessions 2020 (AHA 2020). Both analyses demonstrated significant lowering of low-density lipoprotein cholesterol (LDL-C) by #NEXLETOL® (bempedoic acid) Tablets by week 12 in specific subgroups, including people who cannot tolerate statins and females, compared to placebo.
In “Efficacy and Safety of Bempedoic Acid in Patients Who Cannot Tolerate Any Dose of a Statin: Pooled Analysis from Phase 3 Clinical Trials,” (Abstract #P2139) data from a subgroup of more than 580 patients not receiving any dose of a statin showed a significant mean reduction of 26.5% (p< 0.001) in LDL-C by week 12 with NEXLETOL vs. placebo. NEXLETOL was generally well tolerated, with treatment-emergent adverse events (TEAEs) comparable across the bempedoic acid and placebo groups.
The poster “Efficacy and Safety of Bempedoic Acid by Sex: Pooled Analyses From Phase 3 Trials” (Abstract #P742) showed NEXLETOL significantly lowered LDL-C at week 12 in both sexes compared with placebo for a pooled population of more than 3,600 patients across four studies. LDL-C lowering was numerically greater in females compared with males across both pools of the study: The placebo-corrected mean reduction was 27.7% for females vs. 22.1% for males (interaction p value=0.079) in the statin-intolerant pool, and 21.2% for females vs. 17.4% for males (interaction p value=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.
Approved earlier this year by the U.S. Food and Drug Administration (FDA) and launched at the height of the COVID-19 pandemic, NEXLETOL is the first oral, once-daily, non-statin LDL-C-lowering medicine available to indicated patients in nearly 20 years. The approval of NEXLETOL was supported by a global pivotal Phase 3 LDL-C-lowering program conducted in more than 3,000 patients with ASCVD and/or HeFH. In these studies, NEXLETOL provided an average of 18% placebo-corrected LDL-C lowering when used with moderate or high-intensity statins. The most common (incidence ≥ 2% and greater than placebo) 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. NEXLETOL 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 effect of NEXLETOL on cardiovascular morbidity and mortality has not yet been determined. Please see important safety information below" (see press release HERE).
See our ESPR Nexletol AmpCard to learn more.