Real-world data supports association between elevated triglyceride levels and increased peripheral arterial revascularisation in high risk statin-treated patients

‘s’s sAmarin Corporation, a biopharmaceutical company focused on the commercialisation and development of therapeutics to improve cardiovascular health, supported the recent presentation of a scientific poster at the European Society of Cardiology (ESC) Congress in Munich, Germany. This analysis indicated that patients with elevated triglycerides (TG) were at a 37% higher rate of requiring a procedure for peripheral arterial revascularisation per unit time than patients with normal TG levels. A conference call will be held Monday, August 27, 2018 to discuss this data and other data presented at ESC 2018 and related insights with respect to Amarin’s potentially landmark cardiovascular outcomes study of Vascepa, REDUCE-IT. Top-line results from REDUCE-IT are anticipated before the end of September 2018. 

The scientific poster is titled, “Triglycerides 150mg/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 retrospective analysis of a large medical claims database was to evaluate the real-world impact of elevated triglycerides on occurrence of peripheral arterial revascularisation in high-risk statin-treated patients.

Patient data from the database were segmented into groups of people with elevated TG levels (≥150mg/dL, n=22,795) and a control cohort with normal TG levels (<150mg/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 revascularisation per unit time than the control cohort. The analysis carried out by Amarin provides evidence to further support that elevated triglycerides are associated with higher rates of peripheral arterial revascularisation.

This poster was authored by Peter P Toth from CGH Medical Center, Sterling, USA. “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 revascularisation procedure in patients with peripheral arterial disease (PAD). Development of PAD often has a significant effect on patient quality of life and drives healthcare utilisation. Unfortunately, PAD is growing as a common disease condition along with changes in population demographics,” said Toth.

PAD is associated with cardiovascular morbidity, reduced quality of life, and increased health care burden. More than 200 million people are affected with PAD worldwide, including almost 40 million people in Europe. In the USA, the prevalence of PAD is at least 6.8 million individuals, with more than 13,000 deaths in 2015 and more than 100,000 hospital discharges in 2014. Interventions for peripheral vascular disease are one of a number of pre-specified data points that are being collected in the Amarin REDUCE-IT cardiovascular outcomes study.

Previously, Amarin presented a real-world data analysis at the 2018 American College of Cardiology (ACC) 67th Annual Scientific Session and Expo in Orlando, USA. This analysis by Amarin reinforced that statin-treated patients at high cardiovascular (CV) risk with controlled low density lipoprotein cholesterol (LDL-C) and elevated triglyceride (TG) levels, TG ≥150mg/dL, had worse CV outcomes and higher overall healthcare costs than statin-treated patients with controlled LDL-C and normal TG levels, TG <150mg/dL, and normal high density lipoprotein cholesterol (HDL-C) >40mg/dL.

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 ≥150mg/dL, as compared with the normal TG group defined as TG <150mg/dL and HDL-C >40mg/dL, were at increased risk of adverse cardiovascular 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 revascularisation
• 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).