News | ACC | April 04, 2022

Esperion Announces Two NEXLETOL Data Presentations at ACC.22

New analyses of thousands of patients spanning Phase 2 and pooled Phase 3 data demonstrate that NEXLETOL safely and significantly lowers LDL-C compared to placebo in patients with renal impairment or hypertension

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April 4, 2022 –  Esperion presented two new analyses from its clinical development program of bempedoic acid (NEXLETOL) at the American College of Cardiology’s 71st Annual Scientific Session & Expo (ACC.22).

The first analysis titled, “Safety and Efficacy of Bempedoic Acid in Patients with Renal Impairment,” was presented by Peter P. Toth, MD, PhD, FCCP, FAHA, FESC, FACC. This analysis of a total of 3,619 patients included in four Phase 3 studies demonstrated that bempedoic acid 180 mg significantly lowered low-density lipoprotein cholesterol (LDL-C) (p<0.0001) regardless of renal function. While patients with severe renal impairment (eGFR <30 mL/min/1.73 m2) or end-stage renal disease receiving dialysis were not recruited for these trials, bempedoic acid was effective and generally well tolerated in the large group of patients with Stage 2 or Stage 3 renal impairment (estimated glomerular filtration rates (eGFR) between 30 and <90 mL/min/1.73 m2).

A second analysis titled, “Safety and Efficacy of Bempedoic Acid in Patients with Hypertension,” was presented by Keith C. Ferdinand, MD, FACC, FAHA, FASH, FNLA. In 3,623 patients with ASCVD included in pooled data from four Phase 3 studies, 78% had a history of hypertension. In these patients, bempedoic acid 180 mg significantly lowered LDL-C. Bempedoic acid was associated with substantial decreases in LDL-C (p<0.0001) regardless of a patient’s hypertension history. The presentation included an analysis of a Phase 2 study of patients with hypertension, where a significant reduction in LDL-C was found among patients with blood pressure ≥140/90 and ≤180/110 mmHg.

“We are encouraged by the findings from our clinical development program across Phase 2 and Phase 3 trials that bempedoic acid can be utilized to lower LDL-C in these high risk hypertensive and renal patients,” said JoAnne Foody, MD, FACC, FAHA, chief medical officer of Esperion. “These additional analyses continue to emphasize the efficacy and safety of bempedoic acid across a wide range of at-risk patients who require additional options to lower their LDL-C.”

Approved by the U.S. Food and Drug Administration (FDA), 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. 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.

Please see full prescribing information for NEXLETOL by clicking here.

Find more ACC22 content here

 

 


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