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


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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.

Author

VAntagePoint Contributor

— VAntage Point Contributors provide insight and perspective on a wide range of Veterans issues. If you’d like to contribute a story to VAntage Point, learn how you can submit a guest blog at http://www.blogs.va.gov/VAntage/how-to-submit-a-guest-post/

Comments

  1. David Sullivan    

    I would be interested.
    Type 2 diabetes and bad ticker. due to Agent Orange

  2. Ronald J Freed    

    Interested. Does Fargo VA participte?

    1. Theris Williams    

      I’m interested in this study, how do I volunteer?

  3. Gary Hicks    

    Here is a list of participating sites and the lead investigator at each facility:

    • Zablocki VA Medical Center- Dr. Hossein G. Almassi
    • Syracuse VA Medical Center – Dr. Pratap Arasu,
    • Captain James A. Lovell Federal Health Care Center- Dr. Rohit Arora
    • Edward Hines Jr. VA Hospital- Dr. Nasrin Azad
    • Michael E. DeBakey VA Medical Center- Dr. Jeffrey Bates
    • Malcom Randall VA Medical Center- Dr. Anthony Bavry
    • Minneapolis VA Health Care System- Dr. Yellapragada Chandrashekhar
    • Memphis VA Medical Center – Dr. Richard D Childress
    • Buffalo VA Medical Center – Dr. John Corbelli
    • Dallas VA Medical Center – Dr. Fredrick L Dunn
    • Ann Arbor VA Healthcare System- Dr. Claire Duvernoy
    • Ralph H. Johnson VA Medical Center- Dr. Valerian Fernandes
    • VA Loma Linda Healthcare System- Dr. Ronald Fernando
    • Louis Stokes Cleveland Dept of VA Medical Center- Dr. Jonathan Goldberg
    • Birmingham VA Medical Center – Dr. Fadi Hage
    • Cincinnati Veterans Affairs Medical Center- Dr. Hanan Kerr
    • G.V. Montgomery VA Medical Center- Dr. Kent Kirchner
    • Robley Rex VA Medical Center- Dr. Sathya Krishnasamy
    • VA Palo Alto Division – Dr. Jennifer Lee
    • VA Connecticut Healthcare System- Dr. Judith Meadows
    • VA Sierra Nevada Health Care System – Dr. Nidhi Mehta
    • VA Greater Los Angeles Healthcare System- Dr. Freny Mody
    • Tennessee Valley Healthcare System- Dr. Harvey Murff
    • James A. Haley VA Medical Center- John Nobel
    • White River Junction VA Medical Center- Dr. Daniel O’Rourke
    • Atlanta VA Medical Center – Dr. Darin Olson
    • Bay Pines VA Healthcare System- Dr. Anna Paszczuk
    • VA Eastern Kansas Health Care- Dr. Arnold Pollak
    • VA Pittsburgh Healthcare System- Dr. Aref Rahman
    • Raymond G. Murphy VA Medical Center- Dr. Devona Ratliff
    • Phoenix Veterans Administration Health Care System- Dr. Shakaib Rehman
    • San Juan VA Medical Center – Dr. Luis Rodriguez-Ospina
    • Kansas City VA Medical Center- Dr. Virginia Savin
    • VA Nebraska-Western Iowa Health Care System- Dr. Vijay Shivaswamy
    • Washington D.C. VA Medical Center – Dr. Pamela Steele
    • Baltimore VA Medical Centre- Dr. Nanette Steinle
    • Central Arkansas Veterans Healthcare System- Dr. Barry Uretsky
    • VA Long Beach Healthcare System- Dr. Anthony Vo
    • Indianapolis VA Medical Center – Dr. James Walsh
    • Providence VA Medical Center- Dr. Wen-chih Wu
    • Hunter Holmes McGuire VA Medical Center- Dr. Franklin Zieve

  4. Ronald D Risdon    

    When does enrollment start, or is the research Dr going to pick his patients based on lab reports?

  5. Pamela Samuel Depusoir    

    Any VA hospital in North Carolina participating in the study?

  6. Stephen Douglas Martin    

    I live in Charleston, S C and and have Type 2 diabetes. I would be very interested in the study at that Ralph H Johnson study. I also have coronary heart disease..

  7. Irvin Van Patten    

    I would like to be considered for this.

  8. Irvin Van Patten    

    Contact me with additional information 9p

  9. James E. Mooney    

    i would be interested in participating in the study….61yo male…insulin dependent for 17 years…
    please feel free to contact me…
    James Mooney
    US Navy Retired

  10. Kenneth a Adams    

    If Massachusetts va clinics would be part of study; would have interest to be part of study.

  11. richard c perry    

    i would like to sigh up for the study.in syracuse va n.y.

  12. Frank Olivas    

    Does George E Wallen vs center salt lake participate I would be a good candidate.

  13. Larry Marable    

    Why didn’t they put the above locations in the article. Dumb.

  14. Joe Barrett    

    I’m shocked Biloxi did not make the list.

  15. Mark J. Radder    

    I’m a 71 year old male, retired military. I have type II, Afib pace maker. elevated cholesterol and triglyceride. I’m interested from Buffalo N.Y. area.

  16. Ellen Prechtl    

    I would be interested, but you have nothing in the Colorado Area. 57 YO Female, diabetes T2 for 14 years, on 5 diabetes meds, including Crestor. Still have high trigylcerides. (176)

  17. Geoffrey moni    

    I have been type 2 diabetic for the last more than 25 year and would have benefited from this research if it was available in our county.

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