Real-World Data Supports Association Between Elevated Triglyceride Levels and Increased Peripheral Arterial Revascularization in High Risk Statin-Treated Patients
The scientific poster #P739 is titled, “Triglycerides 150 mg/dL and above are associated with an increased risk of peripheral arterial revascularization in high-risk statin-treated patients: A real-world analysis.” These data were based on a retrospective analysis of de-identified medical records from patient experiences within a leading national information and technology-enabled health services business. De-identified patient data is health information from a medical record that has been stripped of all “direct identifiers”, that is, all information that can be used to identify the patient from whose medical record the health information was derived. The purpose of this retrospective analysis of a large medical claims database was to evaluate the real-world impact of elevated triglycerides on occurrence of peripheral arterial revascularization in high-risk statin-treated patients.
Patient data from the database were segmented into groups of people with elevated TG levels (≥150 mg/dL, n=22,795) and a control cohort with normal TG levels (<150 mg/dL, n=22,884). In a multivariate analysis, patients with elevated TG levels were at a 37% higher rate of requiring a procedure for peripheral arterial revascularization per unit time than the control cohort. This analysis provides evidence to further support that elevated triglycerides are associated with higher rates of peripheral arterial revascularization.
This poster was authored by
“We are pleased to present this new information that adds to our body of knowledge regarding the correlation of elevated TG levels to increased risk of revascularization procedure in patients with peripheral arterial disease (PAD). Development of PAD often has a significant effect on patient quality of life and drives healthcare utilization. Unfortunately, PAD is growing as a common disease condition along with changes in population demographics,” said
PAD is associated with cardiovascular morbidity, reduced quality of life, and increased health care burden. 1,2,3 More than 200 million people are affected with PAD worldwide, including almost 40 million people in
Patients with diabetes mellitus and/or established atherosclerotic cardiovascular disease were followed longitudinally for up to five years. Those patients with elevated TG levels, defined as TG ≥ 150 mg/dL, as compared with the normal TG group defined as TG < 150 mg/dL and HDL-C >40 mg/dL, were at increased risk of adverse CV outcomes after multivariable adjustment as follows:
- 26% increased risk for the composite initial major adverse CV event (MACE) (95% confidence interval [CI] 1.19-1.34)
- The increase in composite MACE in the elevated TG group was driven by a 32% (95% CI 1.20-1.45) increased risk of non-fatal myocardial infarction and a 46% (95% CI 1.33-1.61) increased risk of coronary revascularization
- 12% higher average total healthcare cost (95% CI 1.08-1.16)
- 13% higher rate of occurrence of initial inpatient hospital stay (95% CI 1.10-1.17)
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Amarin will host a conference call at 8:00 a.m. ET, August 27, 2018 to discuss this presentation and other data presented at ESC 2018. The call will be accessible through the investor relations section of the company’s website at www.amarincorp.com. The call can also be heard via telephone by dialing 877-407-8033. A replay of the call will be made available for a period of two weeks following the conference call. To hear a replay of the call, dial 877-481-4010 (inside
Additional information on clinical studies of Vascepa can be found at www.clinicaltrials.gov.
About VASCEPA® (icosapent ethyl) Capsules
Vascepa® (icosapent ethyl) capsules are a single-molecule prescription product consisting of the omega-3 acid commonly known as
FDA-Approved Indication and Usage
- Vascepa (icosapent ethyl) is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia.
- The effect of Vascepa on the risk for pancreatitis and cardiovascular mortality and morbidity in patients with severe hypertriglyceridemia has not been determined.
Important Safety Information for Vascepa
- Vascepa is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to Vascepa or any of its components.
- In patients with hepatic impairment, monitor ALT and AST levels periodically during therapy.
- Use with caution in patients with known hypersensitivity to fish and/or shellfish.
- The most common reported adverse reaction (incidence > 2% and greater than placebo) was arthralgia (2.3% for Vascepa, 1.0% for placebo). There was no reported adverse reaction > 3% and greater than placebo.
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Vascepa has been approved for use by the
About Cardiovascular Disease
Worldwide, cardiovascular disease (CVD) remains the #1 killer of men and women. In
Beyond the cardiovascular risk associated with LDL-C, genetic, epidemiologic, clinical and real-world data suggest that patients with elevated triglycerides (TG) (fats in the blood), and TG-rich lipoproteins, are at increased risk for cardiovascular disease. 6, 7, 8, 9
Leading clinical investigations seeking to address cardiovascular risk reduction beyond lowering LDL-C focus on interrupting the atherosclerotic process (e.g., plaque formation and instability) by beneficially affecting other lipid, lipoprotein and inflammation biomarkers and cellular functions thought to be related to atherosclerosis and cardiovascular events.
This press release contains forward-looking statements, including statements about the patient risk profiles thought to be related to triglyceride levels as well as statements concerning the REDUCE-IT cardiovascular outcomes study such as the anticipated inclusion of certain patient populations, related timing and announcements with respect to final outcomes and the anticipated successful completion of the REDUCE-IT study. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. Among the factors that could cause actual results to differ materially from those described or projected herein include uncertainties associated generally with retrospective subset analyses, research on biomarkers thought to be relevant in the treatment of cardiovascular disease, research and development and clinical trial risk generally, including the risk that study results in modest sample sizes may not be predictive of future results in larger studies, that studied parameters may not have clinically meaningful effect and the risk that patents may not adequately protect Vascepa against competition. A further list and description of these risks, uncertainties and other risks associated with an investment in
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Investors and others should note that
1 Benjamin EJ, et al.
2 Creager MA. Protecting Life and Limb in Peripheral Artery Disease. Circulation. 2018;137:351-3.
3 Valdivielso P, et al. Peripheral arterial disease, type 2 diabetes and postprandial lipidaemia: Is there a link? World J Diabetes. 2014;5:577-85.
4 Fowkes FG, et al. Comparison of global estimates of prevalence and risk factors for peripheral artery disease in 2000 and 2010: a systematic review and analysis. Lancet. 2013;382:1329– 40.
6 Budoff M. Triglycerides and triglyceride-rich lipoproteins in the causal pathway of cardiovascular disease. Am J Cardiol. 2016;118:138-145.
7 Toth PP, Granowitz C, Hull M, et al. High triglycerides increase cardiovascular events, medical costs, and resource utilization in a real-world analysis of statin-treated patients with high cardiovascular risk and well-controlled low-density lipoprotein cholesterol [abstract]. Circulation. 2017;136(suppl 1):A15187.
8 Nordestgaard BG. Triglyceride-rich lipoproteins and atherosclerotic cardiovascular disease - New insights from epidemiology, genetics, and biology. Circ Res. 2016;118:547-563.
9 Nordestgaard BG, Varbo A. Triglycerides and cardiovascular disease. Lancet. 2014; 384: 626–635.
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