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
ANN ARBOR, Mich., April 03, 2022 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today 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.
NEXLETOL® (bempedoic acid) Tablet
NEXLETOL is a first-in-class ATP Citrate Lyase (ACL) inhibitor that lowers LDL-C by reducing cholesterol biosynthesis and up-regulating the LDL receptors. NEXLETOL is the first oral, once-daily, non-statin LDL-C lowering medicine approved in the U.S. in nearly 20 years for patients with ASCVD or HeFH. NEXLETOL was approved by the FDA in February 2020, and by the European Commission in April 2020 under the name NILEMDO® (bempedoic acid) with a different label. Daiichi Sankyo Europe has licensed exclusive commercialization rights to bempedoic acid in the European Economic Area, Switzerland, Turkey, and United Kingdom, from Esperion.
INDICATION
NEXLETOL is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C. Limitations of Use: The effect of NEXLETOL on cardiovascular morbidity and mortality has not been determined.
IMPORTANT SAFETY INFORMATION
Warnings and Precautions: Hyperuricemia: NEXLETOL may increase blood uric acid levels. Hyperuricemia may occur early in treatment and persist throughout treatment, and may lead to the development of gout, especially in patients with a history of gout. Assess uric acid levels periodically as clinically indicated. Monitor for signs and symptoms of hyperuricemia, and initiate treatment with urate-lowering drugs as appropriate. Tendon Rupture: NEXLETOL is associated with an increased risk of tendon rupture or injury. In clinical trials, tendon rupture occurred in 0.5% of patients treated with NEXLETOL versus 0% of patients treated with placebo, and involved the rotator cuff (the shoulder), biceps tendon, or Achilles tendon. Tendon rupture occurred within weeks to months of starting NEXLETOL. Tendon rupture may occur more frequently in patients over 60 years of age, patients taking corticosteroid or fluoroquinolone drugs, patients with renal failure, and patients with previous tendon disorders. Discontinue NEXLETOL at the first sign of tendon rupture. Avoid NEXLETOL in patients who have a history of tendon disorders or tendon rupture.
Adverse Reactions: In clinical trials, the most commonly reported 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. Reactions reported less frequently, but still more often than with placebo, included benign prostatic hyperplasia and atrial fibrillation.
Drug Interactions: Simvastatin and Pravastatin: Concomitant use results in increased concentrations and increased risk of simvastatin or pravastatin-related myopathy. Use with greater than 20 mg of simvastatin or 40 mg of pravastatin should be avoided.
Lactation and Pregnancy: It is not recommended that NEXLETOL be taken during breastfeeding. Discontinue NEXLETOL when pregnancy is recognized, unless the benefits of therapy outweigh the potential risks to the fetus. Based on the mechanism of action, NEXLETOL may cause fetal harm.
Please see full Prescribing Information for NEXLETOL by clicking here.
Esperion Therapeutics
Esperion works hard to make our medicines easy to get, easy to take and easy to have. We discover, develop, and commercialize innovative medicines and combinations to lower cholesterol, especially for patients whose needs aren't being met by the status quo. Our entrepreneurial team of industry leaders is inclusive, passionate and resourceful. We are singularly focused on managing cholesterol so you can improve your health easily. Esperion commercializes NEXLETOL® (bempedoic acid) and NEXLIZET® (bempedoic acid and ezetimibe) Tablets and is the leader in the development of convenient oral, once-daily non-statin LDL-cholesterol lowering drugs for patients with high levels of bad cholesterol. For more information, please visit and follow us on Twitter at .
Forward-Looking Statements
This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding commercial products, clinical development, and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "suggest," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions. Any express or implied statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Forward-looking statements involve risks and uncertainties that could cause Esperion's actual results to differ significantly from those projected, including, without limitation, the impact of the ongoing COVID-19 pandemic on our business, revenues, results of operations and financial condition, the net sales, profitability, and growth of Esperion's commercial products, clinical activities and results, supply chain, commercial development and launch plans, and the risks detailed in Esperion's filings with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Esperion disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release, other than to the extent required by law.
Contact:
Corporate Communications
corporateteam@esperion.com
對數千名患者進行的跨越2期和3期數據的新分析表明,與安慰劑相比,NEXLETOL安全且顯著地降低了腎功能損害或高血壓患者的低密度脂蛋白
密歇根州安娜堡,2022年4月3日(Global Newswire)--Esperion(納斯達克:ESPR)今天公佈了其苯培多酸(NEXLETOL)臨牀開發計劃的兩項新分析®)在美國心臟病學會第71屆年度科學會議和博覽會(ACC.22)上。
第一項分析題為“苯哌多酸在腎損害患者中的安全性和有效性”,由Peter P.Toth,醫學博士,PHD,FCCP,FAHA,FESC,FACC提出。這項對4項3期研究共3,619名患者的分析表明,苯培多酸180毫克顯著降低低密度脂蛋白膽固醇(LDL-C)(P2)或接受透析的終末期腎病患者不在這些試驗中,苯培多酸在大部分2期或3期腎損傷(估計腎小球濾過率(EGFR)在30至2之間)患者中是有效的,總體耐受性良好。
第二項分析題為“苯哌多酸在高血壓患者中的安全性和有效性”,由醫學博士、FACC、FAHA、FASH和FNLA的Keith C.Ferdinand提出。在4個3期研究的彙集數據中,3623名ASCVD患者中,78%有高血壓病史。在這些患者中,苯培多酸180 mg顯著降低了低密度脂蛋白-C。苯哌酸與低密度脂蛋白的顯著降低有關(p
Esperion的首席醫療官、醫學博士、FACC、FAHA的JoAnne Foody説:“我們對第二階段和第三階段的臨牀開發計劃的發現感到鼓舞,這些發現表明苯培多酸可用於降低這些高危高血壓和腎病患者的低密度脂蛋白-C。”這些額外的分析繼續強調苯培多酸在廣泛的高危患者中的有效性和安全性,這些患者需要額外的選擇來降低他們的低密度脂蛋白-C。
經美國食品和藥物管理局(FDA)批准,NEXLETOL是近20年來第一種可供指定患者使用的口服、每日一次的非他汀類降低密度脂蛋白藥物。NEXLETOL的批准得到了全球Pivotal 3期降低低密度脂蛋白計劃的支持,該計劃在3000多名ASCVD和/或HeFH患者中進行。在這些研究中,當與中強度或高強度的他汀類藥物一起使用時,NEXLETOL提供了平均18%的安慰劑校正的低密度脂蛋白降低。Nexletol被認為是飲食的補充和最大耐受性的他汀類藥物,用於治療需要額外降低低密度脂蛋白-C的成人HeFH或ASCVD。Nexletol對心血管發病率和死亡率的影響尚未確定。請參閲下面的重要安全信息。
NEXLETOL®(苯培多酸)片
NEXLETOL是一種一流的ATP檸檬酸裂解酶(ACL)抑制劑,通過減少膽固醇的生物合成和上調低密度脂蛋白受體來降低低密度脂蛋白-C。NEXLETOL是近20年來美國批准的第一種口服、每日一次的非他汀類降低密度脂蛋白藥物,用於ASCVD或HeFH患者。NEXLETOL於2020年2月獲得FDA批准,並於2020年4月獲得歐盟委員會批准,名稱為NILEMDO®(苯培多酸)具有不同的標籤。第一三共歐洲公司已經從Esperion公司獲得了苯培多酸在歐洲經濟區、瑞士、土耳其和英國的獨家商業化授權。
指示
Nexletol被指定為飲食的輔助藥物和最大耐受性的他汀類藥物,用於治療患有雜合性家族性高膽固醇血癥或需要額外降低低密度脂蛋白-C的已確定的動脈粥樣硬化性心血管疾病的成年人。使用限制:NEXLETOL對心血管發病率和死亡率的影響尚未確定。
重要安全信息
警告和注意事項: 高尿酸血癥:NEXLETOL可能會提高血尿酸水平。高尿酸血癥可能在治療早期發生,並持續到整個治療過程,並可能導致痛風的發展,特別是在有痛風病史的患者中。根據臨牀指示定期評估尿酸水平。監測高尿酸血癥的體徵和症狀,並酌情開始使用降尿酸藥物治療。肌腱斷裂:NEXLETOL與肌腱斷裂或損傷的風險增加有關。在臨牀試驗中,服用NEXLETOL的患者中發生肌腱斷裂的比例為0.5%,而服用安慰劑的患者中發生肌腱斷裂的比例為0%,並累及肩袖(肩膀)、二頭肌腱或跟腱。肌腱斷裂發生在開始使用NEXLETOL的幾周到幾個月內。肌腱斷裂可能在60歲以上的患者、服用皮質類固醇或氟喹諾酮類藥物的患者、腎功能衰竭患者和既往肌腱疾病患者中更常見。在肌腱斷裂的第一個跡象時停止使用NEXLETOL。對於有肌腱紊亂或肌腱斷裂病史的患者,應避免使用Nexletol。
不良反應:在臨牀試驗中,最常見的不良反應是上呼吸道感染、肌肉痙攣、高尿酸血癥、背痛、腹痛或不適、支氣管炎、四肢疼痛、貧血和肝酶升高。報告的反應較少,但仍高於安慰劑,包括良性前列腺增生症和心房顫動。
藥物相互作用:辛伐他汀和普伐他汀:同時使用會增加辛伐他汀或普伐他汀相關性肌病的濃度和風險。應避免使用超過20毫克的辛伐他汀或40毫克的普伐他汀。
哺乳和懷孕:不建議在母乳餵養期間服用奈西洛爾。除非治療的益處超過對胎兒的潛在風險,否則在確認懷孕的情況下停止使用Nexletol。根據其作用機制,Nexletol可能會對胎兒造成傷害。
請點擊此處查看NEXLETOL的完整預製信息。
Esperion治療公司
Esperion努力使我們的藥物易於獲得、易於服用和易於獲得。我們發現、開發和商業化降低膽固醇的創新藥物和組合,特別是對現狀無法滿足其需求的患者。我們由行業領導者組成的創業團隊包容、熱情和足智多謀。我們特別專注於管理膽固醇,這樣您就可以輕鬆地改善您的健康。Esperion公司將NEXLETOL商業化®(苯培多酸)和奈替西汀®該公司在開發方便的口服、每日一次的非他汀類低密度脂蛋白降膽固醇藥物方面處於領先地位,適用於高水平的壞膽固醇患者。欲瞭解更多信息,請訪問並在Twitter上關注我們。
前瞻性陳述
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