The study population took part in the landmark ORIGIN trial, which evaluated hypoglycemia effects in persons with high CV risk and diabetes.
A study published this month in the journal Circulation discusses how a research tool was able to isolate 10 biomarkers that, when combined with clinical risk factors, can predict which patients with diabetes or prediabetes are most likely to suffer cardiovascular (CV) events.1,2
DiscoveryMAP technology, made by Myriad RBM, also identified 5 more biomarkers that when combined with the first 10, could predict increased risk of death in these patients.
The paper, “Identifying Novel Biomarkers for Cardiovascular Events or Death in People with Dysglycemia,” uses material gathered from 8401 participants in an earlier trial, known as ORIGIN (Outcome Reduction with Initial Glargine Intervention). That landmark trial was designed to find out how hypoglycemia affects CV outcomes for persons with high CV risk and dysglycemia and whether insulin glargine or standard therapy caused worse outcomes.3
In the current study, researchers from the Population Health Research Institute (PHRI) and Sanofi used the DiscoveryMAP platform to test serum from the ORIGIN participants for 237 biomarkers that could be predictive of CV events. From these results, researchers pinpointed which biomarkers could better predict future CV events or death than could be anticipated from clinical or biochemical data.
The result was a set of 10 biomarkers that can be combined with clinical risk factors to determine which patients with dysglycemia are at higher risk of having a heart attack, stroke or cardiovascular death. An additional 5 biomarkers were identified that, along with the first 10, had the greatest ability to predict death.
Cardiovascular risk has been a great cause of concern among clinicians and researchers in diabetes and cardiovascular care, especially since the saga involving rosiglitazone. After an article in the New England Journal of Medicine linked the blockbuster drug to heart attacks, the FDA sharply limited sales while it awaited long-term CV outcomes results.4 After that episode, the FDA issued a guidance requiring CV outcomes trials for new diabetes, cholesterol and CV therapies. As an example of this cautious approach, the FDA issued a limited label for the new class of cholesterol drugs, PCSK9 inhibitors, when they were approved this summer, while it awaits long-term CV trial results. The drugs gained broader approval in Europe.5
“Our study is one of the largest scientific investigations in history to identify specific cardiovascular biomarkers associated with serious cardiovascular outcomes, including heart attacks, strokes, and death,” said Hertzel Gerstein, MD, lead investigator and deputy director, PHRI, in a statement. “Our results highlight the potential value of cardiovascular biomarkers for identifying people with dysglycemia at the highest risk of future events.”2
Myriad RBM is a wholly owned subsidiary of Myriad Genetics of Salt Lake City, Utah.
1. Gerstein HC, Pare G, McQueen MJ, et al. Identifying novel biomarkers for cardiovascular events or death in people with dysglycemia [published online October 30, 2015]. Circulation. 2015; doi: 10.1161/CIRCULATIONAHA.115.015744
2. Myriad RBM DiscoveryMAP technology identifies novel biomarkers that may predict increased risk of cardiovascular events in patients with diabetes [press release]. Salt Lake City, UT: GlobeNewswire; November 16, 2015. https://www.myriad.com/investors/press-release-detail/?newsItemId=942825.
3. The ORIGIN Trial Investigators. Characteristics associated with maintenance of mean A1C<6.5% in people with dysglycemia in the ORIGIN trial. Diabetes Care. 2013;36(10)2915-2922.
4. Regan TL. FDA “Mea culpa” part of cautionary tale. Am J Manag Care. 2013;19(SP7):S242-SP243.
5. Caffrey MK. Repatha, Amgen’s PCSK9 competitor, gains FDA approval. American Journal of Managed Care website. http://www.ajmc.com/newsroom/evolocumab-amgens-pcsk9-competitor-gains-fda-approval/P-1. Published August 27, 2015. Accessed November 17, 2015.