In a significant new industry research partnership for the Ohio University Heritage College of Osteopathic Medicine, Vipin Koshal, D.O. (’01), assistant clinical professor of specialty medicine and OhioHealth cardiologist, is serving as principal investigator for the college’s part in a multi-site industry-sponsored clinical study. The research, in which OhioHealth is also a partner, is taking place at sites in 20 countries around the world, and aims to enroll approximately 10,000 subjects in a Phase 3 drug trial of a cholesterol-lowering medication.
The research is supported here by the Clinical & Translational Research Unit (CTRU) at the Heritage College. OhioHealth diabetologist Amber Healy, D.O. (’09), a Heritage College assistant clinical professor of specialty medicine and director of the diabetes fellowship program, is a co-investigator. The purpose of the study is to find out if pemafibrate, the study drug, reduces cardiovascular events, such as heart attack, stroke, and death from these conditions, in adults with type 2 diabetes who have elevated triglycerides and low HDL (or “good”) cholesterol.
The work represents a team effort to benefit patients. “The Heritage College and OhioHealth are both committed to these collaborative projects in which research-related resources, such as our CTRU staff and OhioHealth’s facilities, are employed collectively to address significant clinical problems,” said Darlene Berryman, Ph.D., R.D., L.D. associate dean for research and innovation at the Heritage College.
Koshal explained that pemafibrate is one of a class of drugs called fibrates, which are known to reduce high levels of triglycerides (the most common type of fat found in the body) and LDL, or “bad” cholesterol. A combination of high triglycerides and high LDL cholesterol, or of high triglycerides and low HDL cholesterol, contributes to fatty buildups in arteries and increases the risk for cardiovascular problems such as heart attack and stroke.
Based on existing research, pemafibrate is thought to be more effective at lowering triglycerides and LDL cholesterol than other fibrate drugs now on the market. “It does work differently than other drugs in its class that are available, in that it’s more potent,” Koshal said. However, he added, no research has previously been done to look at whether this effect actually reduces the incidence of heart attack or stroke. That’s one thing the new study aims to do.
The study is sponsored by the firm Kowa Pharmaceuticals America, Inc., and is headed by Paul M. Ridker, M.D., Eugene Braunwald Professor of Medicine at Harvard University and director of the Center for Cardiovascular Disease Prevention at Brigham and Women's Hospital in Boston. “He’s a very well-known cardiovascular researcher, and we’ve been in studies with this research group before,” Koshal said, adding that when the pemafibrate study got to its second phase, the Heritage College reached out and asked to be included among the study sites.
“They know we’re a small site, but we try to do quality work, and I think that’s been recognized,” he said. He added that he hopes to recruit 10 to 20 test subjects.
Lee Ann Williams, associate director for clinical research operations at the CTRU, said the unit’s clinical research nurses will do the hands-on work of conducting the study. She said that Ridker’s research group “does some fantastic work,” and that taking part in one of its studies will be advantageous for the college and the CTRU.
“Obviously any industry dollars that are coming in are going to assist with our sustainability,” she noted, adding that contributing high quality data to the study will maintain and enhance the unit’s attractiveness as a site in such partnerships. “Performance is very indicative of whether you get future work (of this kind),” she explained.
The CTRU is also assisting in recruitment of study subjects from around the region, she said.
In addition to its other aims, the study will also test whether pemafibrate has other possible benefits in patients with diabetes and will test the drug’s safety. Subjects who qualify can expect to participate for approximately five years and compensation will be provided for time and travel to study visits. Enrollment is now underway; those interested in volunteering as subjects can find more information on the CTRU website.