Lowering Elevated LDL-C Remains a Significant Unmet Need

Cardiovascular disease (CVD), which results in heart attacks, strokes and other cardiovascular events, represents the number one cause of death and disability globally. According to American Heart Association estimates, in the U.S.:

  • CVD accounts for 1 in 3 deaths
  • Someone has a heart attack approximately every 40 seconds
  • CVD expenses, including stroke, in the U.S. were $317 billion in 2012-2013; including the cost of healthcare services, medications and lost productivity. (1)

Elevated LDL-C is a significant risk factor for cardiovascular disease. The CDC (Centers for Disease Control) through NHANES (National Health & Nutrition Examination Survey) estimates that 81 million(2) U.S. adults have elevated levels of LDL-C (also known as hypercholesterolemia). In the U.S., increasing attention has been placed on aggressive LDL-C lowering. This has led to the combination of statins with other treatments to reach LDL-C goals.

Current Treatment Options May Not Be Adequate for All Patients

Statins are the standard of care for patients with hypercholesterolemia today and are effective at lowering LDL-C, with well-documented benefits. However, many patients still need additional lowering despite taking maximally tolerated statin therapy. In addition, there is a significant subset of patients unable to tolerate statins due to adverse events, including: muscle pain or weakness; increased glucose levels; and in rare and extreme cases, muscle breakdown, kidney failure, and death.

  • Approximately 40 million(2) U.S. adults with elevated LDL-C levels are taking a statin.
  • There are 12 – 13 million ASCVD and/or HeFH Patients with elevated LDL-C who are unable to achieve their LDL-C treatment goal, despite taking maximally tolerated statin therapy(3).
  • Published literature suggests that 10% of patients cannot tolerate any statin therapy due to muscle pain or weakness associated with statin use. This corresponds to ~4 million patients in the U.S. who are considered statin intolerant.

Additionally, patients with Atherosclerostic Cardiovascular Disease (ASCVD) or Heterozygous Familial Hypercholesterolemia (HeFH) who require additional LDL-C lowering on top of maximally tolerated statin therapy represent a high-risk patient population with an important unmet medical need. Approximately 12-13 million(3) patients with ASCVD or HeFH in the U.S are currently taking maximally tolerated statin therapy but are unable to achieve their LDL-C treatment goal. They remain at risk for cardiovascular disease and while a number of therapeutic alternatives for patients with ASCVD or HeFH are currently available or in clinical development, we believe that patients, physicians and payers will continue to first seek convenient, once-daily, oral small molecule therapies to combine with maximally tolerated lipid-modifying therapies.

Pursuing Complementary Non-Statin LDL-C Lowering Therapies for Statin Intolerant and Residual Risk Patients

Esperion is initially pursuing the clinical development of bempedoic acid for patients with ASCVD and/or HeFH with elevated LDL-C who are not adequately treated with current lipid-modifying therapies.

Additionally, Esperion is developing the bempedoic acid / ezetimibe combination pill as a highly effective oral, once-daily, non-statin LDL-C lowering therapy for patients with hypercholesterolemia who are not adequately treated with current lipid-modifying therapies, including those patients considered statin intolerant.

References

(1) Mozaffarian D, Benjamin EJ, Go AS, Arnett DK, Blaha MJ, Cushman M, Das SR, de Ferranti S, Després J-P, Fullerton HJ, Howard VJ, Huffman MD, Isasi CR, Jiménez MC, Judd SE, Kissela BM, Lichtman JH, Lisabeth LD, Liu S, Mackey RH, Magid DJ, McGuire DK, Mohler ER III, Moy CS, Muntner P, Mussolino ME, Nasir K, Neumar RW, Nichol G, Palaniappan L, Pandey DK, Reeves MJ, Rodriguez CJ, Rosamond W, Sorlie PD, Stein J, Towfighi A, Turan TN, Virani SS, Woo D, Yeh RW, Turner MB; on behalf of the American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics—2016 update: a report from the American Heart Association. Circulation. 2016;133:000-000.

(2) Glickman M. 2018 Investor and Analyst Day. The Opportunity, the Providers, and the Patients. July 2018. http://investor.esperion.com/static-files/978fb8ef-869c-4ee2-b54c-6ae7ec2bc59a

(3) Esperion analysis, NHANES 2018.