|The following article is part of conference coverage from the American Diabetes Association’s 78th Scientific Sessions (ADA 2018) in Orlando,Florida. Endocrinology Advisor’s staff will report on medical research and technological advances in diabetes and diabetes education, conducted by experts in the field. Check back for the latest news from ADA 2018.|
For those with a high cardiovascular risk treated with a statin, increased triglyceride levels and diabetes are significant predictors of worse cardiovascular outcomes in the future. These findings were presented at the American Diabetes Association’s 78th Scientific Session held in Orlando, Florida, June 22-26, 2018.
Peter P. Toth, MD, PhD, and colleagues conducted a retrospective administrative claims analysis of the Optum Research Database to identify outcomes of patients treated with a statin drug. The purpose of the study was to further understand the real-world burdens of elevated triglyceride level and diabetes.
Patients were chosen who were ≥45 years old, had diabetes and/or atherosclerotic cardiovascular disease, had filled statin prescriptions in 2010, and had follow-up data for ≥6 months. Patients with triglyceride levels 200-499 mg/dL (n=13,411) and a comparator cohort with triglyceride level <150 mg/dL and high-density lipoprotein cholesterol >40 mg/dL (n=32,506) were included in this analysis. Patients with a day’s supply of niacin on the index date and other medical conditions were excluded from the study.
Multivariate analyses revealed a 35% higher rate of occurrence of composite major cardiovascular events in those with high triglyceride level vs the comparator cohort (hazard ratio [HR] 1.349, 95% CI, 1.225-1.485; P <0.001). Diabetes was found to be a significant predictor of CV events, costs, and risk of inpatient hospital stay.
It is well known that elevated triglyceride level and diabetes mellitus are important factors in predicting cardiovascular events for patients at high risk. Although statin therapy is generally known to reduce risk for cardiovascular events, residual risks remain. People with these residual risks often also incur increased healthcare costs. Those who participated in this study were found to have poorer economic outcomes as a result of their higher medical costs.
Investigators concluded that diabetes is a significant predictor of major cardiovascular events, higher average monthly healthcare costs, and likelihood of inpatient hospital stays for patients taking statin drugs. The investigators’ findings reveal potential considerations that should be addressed when prescribing statin drugs.
Endocrinology Advisor: Were these study results stratified based on low-intensity and high-intensity statins?
Dr. Toth: “These data were not stratified by statin dose or relative potency. However, the relationship between hypertriglyceridemia and increased risk for acute cardiovascular events despite statin therapy held even after comprehensive adjustment for LDL, non-HDL, and HDL.”
Endocrinology Advisor: Despite adequate treatment with statins, there seems to be an increased residual risk of CVD leading to high health care costs and hospitalizations. Based on these findings, what additive pharmacotherapy options would you recommend to high-risk statin-treated patients with persistent hyperlipidemia who are not candidates for PCSK9 inhibitors?
Dr. Toth: “If the patient still had a high LDL after being on the highest tolerated dose of a statin, then the clear choice would be the addition of ezetimibe. If the patient’s primary residual issue was elevated triglyceride, there is support from the JELIS trial (NCT00231738) which demonstrated that the addition of EPA to ongoing statin therapy, particularly in patients with triglycerides over 150, incurred benefit. The fibrate trials do consistently demonstrate benefit in patients in the subgroup with high triglycerides and low HDL. A more definitive response to this question will be provided by the REDUCE-IT (NCT01492361) and STRENGTH (NCT02104817) trials using omega-3 fatty acids, as well as the PROMINENT trial (NCT03071692) which is utilizing a new PPAR modulator that acts much like a fibrate.”
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Toth PP, Granowitz C, Hull M, Philip S. Diabetes mellitus and high triglycerides are significant predictors of major cardiovascular events and increased health care costs and resource utilization—A real-world analysis of high-risk statin-treated patients. Presented at: ADA 2018 78th Scientific Sessions; June 22-26, 2018; Orlando, FL. Poster 416-P.