41 VA medical centers to participate in landmark study to test relationship between diabetes and heart health

Veterans with Type 2 diabetes and elevated triglycerides have an increased risk for cardiac events and may be eligible to participate in a new study sponsored by KOWA Research Institute, Inc. that aims to reduce this risk.

Dr. Jacob Joseph and the Clinical Research Partnerships and Innovations Program based in Boston and Dr. Marshall Elam at the Memphis VA are preparing 41 VA medical centers so that eligible Veterans can participate in the landmark five-year study aimed to reduce cardiovascular events by reducing triglycerides in patients with diabetes.

“Multiple studies suggest that high levels of triglycerides increases the risk of cardiovascular disease such as heart attacks and strokes,” Joseph said.  “We are very excited that VA will play a major role in this landmark study that will examine whether reducing triglyceride levels will decrease the risk of cardiovascular events in Veterans with diabetes and high triglycerides.”

The trial itself is an international study directed by Dr. Paul Ridker and Dr. Aruna Pradhan of the Center for Cardiovascular Disease Prevention, Brigham & Women’s Hospital and Harvard Medical School. Pradhan is also a staff cardiologist at VA Boston and works closely with Joseph and Elam to facilitate VA network participation.

Although the final impact of the study will not be known until 2022, the VA consortium of sites and the Clinical Research Partnerships and Innovations Program is excited to continue to enroll patients and develop more innovations that could help us answer a very important question in the field of cardiovascular prevention.

“This trial is unprecedented,” said Gary Gordon, M.D., president of Kowa Research Institute, Inc. “Statins are effective in lowering cardiovascular risk among patients with high cholesterol, but residual risk remains, particularly in patients with high triglyceride levels and low HDL-C levels.  Kowa will be the first company to run a major, randomized clinical trial investigating whether modulating PPAR-α to lower triglycerides and increase functional HDL in diabetic patients can reduce cardiovascular risk when added to statin therapy.”

Kowa specifically set out to create the most potent and selective PPAR-α modulator (peroxisome proliferator-activated receptor) ever developed, and succeeded with  a drugged called K-877, which is at least 1,000 times as potent and selective as other drugs.  Kowa has completed clinical development of K-877 for hyperlipidemia in Japan, and has submitted it for approval as a new drug.  Kowa’s clinical studies have shown K-877 significantly reduces triglycerides, ApoC3, and remnant cholesterol and increases functional HDL and FGF21.

Phase 3 of the trial will recruit an estimated 10,000 high-risk diabetic patients worldwide.  All participants will receive aggressive, standard of care management of cardiovascular risk factors including treatment with high-intensity statins.  In addition, patients will receive either K-877 or placebo.  The trial will include diabetic patients with and without established cardiovascular disease and will test whether K-877 reduces the occurrence of heart attacks, hospitalizations for unstable angina requiring unplanned revascularization, stroke, or death from cardiovascular causes.

“Cardiovascular disease remains the number one cause of death worldwide,” said Dr. Gordon.  “Reducing residual cardiovascular risk with K-877 would be valuable to physicians managing patients’ cardiovascular disease.”

About the author: This blog post was issued as a press release by VA’s Veterans Integrated Service Network 1‘s office of communications.