“ Sufferers With Weight problems Who Took NEXLETOL Had been 23% Much less More likely to Expertise a Main Hostile Cardiovascular Occasion (MACE-4) In comparison with Placebo “
“ NEXLETOL Demonstrated Scientific Profit in Traditionally Underrepresented Teams: Ladies and Hispanic/Latinx Sufferers With and With out Cardiovascular Illness (CVD) “
“ CLEAR Outcomes Units New Requirements for Variety and Inclusion with Enrollment of 48% Ladies and 17% Hispanic/Latinx Sufferers “
ANN ARBOR, Mich., April 07, 2024 (GLOBE NEWSWIRE) — Esperion (Nasdaq: NASDAQ:) right this moment introduced the presentation of outcomes from three pre-specified subgroups from CLEAR Outcomes on the 2024 American School of Cardiology’s Annual Scientific Classes (ACC.24): ladies, Hispanic/Latinx, and sufferers with weight problems. These outcomes align with the American School of Cardiology’s strong range, fairness and inclusion applications to drive cultural change throughout the occupation and be sure that the cardiovascular care group is as various because the sufferers they look after and that each one sufferers are represented in cardiovascular analysis. The information additionally reinforce the mission of the ACC: remodeling cardiovascular look after all.
These analyses showcase the advantage of NEXLETOL and the bempedoic acid part of NEXLIZET ® (bempedoic acid and ezetimibe) Tablets in a number of vital but typically understudied populations, stated JoAnne Foody, MD, FACC, FAHA, Chief Medical Officer of Esperion. Bempedoic acid is the one FDA accepted non-statin LDL decreasing remedy to exhibit reductions in MACE in each major prevention and secondary prevention affected person populations. In ladies and Hispanic/Latinx sufferers with or in danger for CVD, bempedoic acid decreased LDL-cholesterol (LDL-C) and inflammatory markers, didn’t worsen glucose or weight, and in flip decreased the chance of main opposed cardiovascular occasions (MACE). These outcomes proceed to bolster the significance of early and aggressive LDL-C decreasing so as to cut back cardiovascular occasions, underscoring the paradigm of ˜even decrease, even earlier is even higher.’
Harold Bays, MD, FOMA, FTOS, FACC, FNLA, FASPC, Louisville Metabolic and Atherosclerosis Analysis Middle, College of Louisville College of Drugs, introduced Bempedoic Acid for Prevention of Cardiovascular Occasions in Sufferers with Weight problems: A CLEAR Outcomes Subset Evaluation. Practically 45% of sufferers in CLEAR Outcomes had weight problems (physique mass index higher than or equal to 30 kg/m2) at first of the research. On this evaluation, sufferers with weight problems handled with bempedoic acid have been 23% much less prone to expertise MACE-4 (cardiovascular (CV) loss of life, nonfatal myocardial infarction (MI), nonfatal stroke, or coronary revascularization) in comparison with placebo. On condition that weight problems is an epidemic and a threat issue for heart problems, clinicians and their sufferers could make extra knowledgeable therapeutic selections upon understanding the CVD outcomes amongst sufferers with weight problems who obtain particular cardiometabolic therapies, stated Dr. Bays.
Fatima Rodriguez, MD, MPH, Stanford Drugs, introduced Traits and Outcomes for Hispanic/Latinx Members with Statin Intolerance Receiving Bempedoic Acid: Outcomes from a CLEAR Outcomes Pre-Specified Subgroup Evaluation. Hispanic/Latinx sufferers represented virtually 17% of these enrolled within the CLEAR Outcomes trial. The Hispanic inhabitants is the biggest ethnic minority within the U.S., but is a inhabitants traditionally underrepresented in scientific trials. This subgroup evaluation confirmed an identical 21% decreasing of LDL-C with bempedoic acid in comparison with placebo in Hispanic/Latinx and non-Hispanic/Latinx alike, confirming the CV threat discount advantage of LDL-C decreasing and the excessive tolerability of bempedoic acid, no matter ethnicity. This evaluation was revealed within the Journal of the American School of Cardiology (JACC).
Leslie Cho, MD, Cleveland Clinic, introduced Traits and Outcomes for Statin-Illiberal Ladies Receiving Bempedoic Acid within the CLEAR Outcomes Trial. CLEAR Outcomes is notable for the very best share enrollment (48%) of females amongst modern lipid-lowering cardiovascular outcomes trials. Within the CLEAR Outcomes trial, the chance of MACE-4 was equally decreased for ladies handled with bempedoic acid in comparison with placebo, thus confirming its LDL-C decreasing profit on CV threat discount, no matter intercourse. This evaluation was concurrently revealed in Circulation.
INDICATION
NEXLIZET and NEXLETOL are indicated:
- The bempedoic acid part of NEXLIZET and NEXLETOL is indicated to cut back the chance of myocardial infarction and coronary revascularization in adults who’re unable to take beneficial statin remedy (together with these not taking a statin) with:
- established heart problems (CVD), or
- at excessive threat for a CVD occasion however with out established CVD.
- As an adjunct to weight loss program:
- NEXLIZET, alone or together with different LDL-C decreasing therapies, to cut back LDL-C in adults with major hyperlipidemia, together with HeFH.
- NEXLETOL, together with different LDL-C decreasing therapies, or alone when concomitant LDL-C decreasing remedy just isn’t attainable, to cut back LDL-C in adults with major hyperlipidemia, together with HeFH.
IMPORTANT SAFETY INFORMATION
NEXLIZET and NEXLETOL are contraindicated in sufferers with a previous hypersensitivity to bempedoic acid or ezetimibe or any of the excipients. Critical hypersensitivity reactions together with anaphylaxis, angioedema, rash, and urticaria have been reported.
Hyperuricemia: Bempedoic acid, a part of NEXLIZET and NEXLETOL, might improve blood uric acid ranges, which can result in gout. Hyperuricemia might happen early in remedy and persist all through remedy, returning to baseline following discontinuation of remedy. Assess uric acid ranges periodically as clinically indicated. Monitor for indicators and signs of hyperuricemia, and provoke remedy with urate-lowering medication as acceptable.
Tendon Rupture: Bempedoic acid, a part of NEXLIZET and NEXLETOL, is related to an elevated threat of tendon rupture or damage. Tendon rupture might happen extra continuously in sufferers over 60 years of age, in these taking corticosteroid or fluoroquinolone medication, in sufferers with renal failure, and in sufferers with earlier tendon problems. Discontinue NEXLIZET or NEXLETOL on the first signal of tendon rupture. Think about different remedy in sufferers who’ve a historical past of tendon problems or tendon rupture.
The commonest opposed reactions within the major hyperlipidemia trials of bempedoic acid, a part of NEXLIZET and NEXLETOL, in ‰¥2% of sufferers and higher than placebo have been higher respiratory tract an infection, muscle spasms, hyperuricemia, again ache, belly ache or discomfort, bronchitis, ache in extremity, anemia, and elevated liver enzymes.
Hostile reactions reported in ‰¥2% of sufferers handled with ezetimibe (a part of NEXLIZET) and at an incidence higher than placebo in scientific trials have been higher respiratory tract an infection, diarrhea, arthralgia, sinusitis, ache in extremity, fatigue, and influenza.
Within the major hyperlipidemia trials of NEXLIZET, essentially the most generally reported opposed reactions (incidence ‰¥3% and higher than placebo) noticed with NEXLIZET, however not noticed in scientific trials of bempedoic acid or ezetimibe, have been urinary tract an infection, nasopharyngitis, and constipation.
The commonest opposed reactions within the cardiovascular outcomes trial for bempedoic acid, a part of NEXLIZET and NEXLETOL, at an incidence of ‰¥2% and 0.5% higher than placebo have been hyperuricemia, renal impairment, anemia, elevated liver enzymes, muscle spasms, gout, and cholelithiasis.
Discontinue NEXLIZET or NEXLETOL when being pregnant is acknowledged until the advantages of remedy outweigh the potential dangers to the fetus. Due to the potential for critical opposed reactions in a breast-fed toddler, breastfeeding just isn’t beneficial throughout remedy with NEXLIZET or NEXLETOL.
Report pregnancies to Esperion Therapeutics, Inc. Hostile Occasion reporting line at 1-833-377-7633.
Esperion Therapeutics¯
At Esperion, we uncover, develop, and commercialize progressive medicines to assist enhance outcomes for sufferers with or in danger for cardiovascular and cardiometabolic ailments. The established order just isn’t assembly the well being wants of tens of millions of individuals with excessive ldl cholesterol “ that’s the reason our group of passionate business leaders is breaking by means of the boundaries that forestall sufferers from reaching their objectives. Suppliers are transferring towards decreasing LDL-cholesterol ranges as little as attainable, as quickly as attainable; we offer the following steps to assist get sufferers there. As a result of with regards to excessive ldl cholesterol, attending to objective just isn’t optionally available. It’s our life’s work. For extra data, go to esperion.com and esperionscience.com and comply with us on X at twitter.com/EsperionInc.
CLEAR Cardiovascular Outcomes Trial¯
CLEAR Outcomes is a part of the CLEAR scientific analysis program for NEXLETOL ® (bempedoic acid) Pill and NEXLIZET ® (bempedoic acid and ezetimibe) Pill. The CLEAR Program seeks to generate vital scientific proof on the security and efficacy of bempedoic acid, a primary in a category ATP citrate lyase inhibitor contained in NEXLETOL and NEXLIZET and its potential position in addressing extra vital unmet medical wants. Greater than 60,000 individuals could have participated in this system by the point of its completion. The CLEAR Program consists of 5 label-enabling Part III research in addition to different key Part IV research with the potential to achieve greater than 70 million individuals with or in danger for CVD primarily based on elevated LDL-C.¯
Ahead-Wanting Statements
This press launch incorporates forward-looking statements which might be made pursuant to the protected harbor provisions of the federal securities legal guidelines, together with statements concerning advertising technique and commercialization plans, present and deliberate operational bills, future operations, industrial merchandise, scientific improvement, together with the timing, designs and plans for the CLEAR Outcomes research and its outcomes, plans for potential future product candidates, monetary situation and outlook, together with anticipated money runway, and different statements containing the phrases anticipate, imagine, estimate, count on, intend, might, plan, predict, venture, recommend, goal, potential, will, would, might, ought to, proceed, and related expressions. Any specific or implied statements contained on this press launch that aren’t statements of historic truth could also be deemed to be forward-looking statements. Ahead-looking statements contain dangers and uncertainties that would trigger Esperion’s precise outcomes to vary considerably from these projected, together with, with out limitation, the online gross sales, profitability, and progress of Esperion’s industrial merchandise, scientific actions and outcomes, provide chain, industrial improvement and launch plans, the outcomes and anticipated advantages of authorized proceedings and settlements, and the dangers detailed in Esperion’s filings with the Securities and Trade Fee. Any forward-looking statements contained on this press launch converse solely as of the date hereof, and Esperion disclaims any obligation or enterprise to replace or revise any forward-looking statements contained on this press launch, apart from to the extent required by legislation.
Esperion Contact Data:
Traders:¯
Alexis Callahan
investorrelations@esperion.com¯
(406) 539-1762
Media:¯
Tiffany Aldrich¯
corporateteam@esperion.com¯
(616) 443-8438¯
