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The University of Nebraska Medical Center is participating in an international clinical trial that provides a completely new approach for keeping stroke patients protected from another stroke or heart attack.
Called the IRIS (Insulin Resistance Intervention after Stroke) Trial, the study is unique because it targets insulin resistance, which affects nearly half of all patients who have had an ischemic stroke or transient ischemic attack (TIA).
Dr. Kernan delivered a Grand Rounds talk Thursday for the UNMC Department of Neurological Sciences. UNMC is one of about 90 sites participating in the IRIS Trial. Pierre Fayad, M.D., the Reynolds Centennial Professor and chairman of the UNMC Department of Neurological Sciences, is the local principal investigator at UNMC, which is the only research site in Nebraska.
More than 1,700 patients have been enrolled in the study over the past four years, Dr. Kernan said, and he hopes to enroll a total of 3,136 patients by the end of 2010. Patients from the United States, Canada and Israel are currently enrolling in the IRIS Trial, he said, and he plans to begin adding patients from Australia, England, Germany, Italy and China later this year.
Dr. Kernan praised UNMC for being one of the top 10 sites in enrolling patients. Dr. Fayad said 29 patients have been enrolled in the trial over the past 35 months, and he anticipates adding another 20-30 patients over the next two years.
Eligible participants in the trial would be men and women, age 39 years or older, who have experienced an ischemic stroke or TIA in the past six months. The patients must be non-diabetic, but have insulin resistance as determined by a special blood test. It is a randomized study with half the participants given pioglitazone and the other half given a placebo. Participants will be followed for an average of four years.
IRIS participants will start by taking one pill daily containing 15 mg of pioglitazone or placebo. The dose will gradually be increased to three pills or 45 mg of pioglitazone or placebo daily. Pioglitazone can be taken with or without food and with or without other medications.
“We already have a number of drugs that can reduce the risk of strokes and heart attacks,” Dr. Fayad said. “These include aspirin and other agents used as blood thinners, statins to lower cholesterol, and blood pressure lowering medications to treat hypertension. If this drug (pioglitazone) works in controlling insulin resistance, it should give us another means of reducing recurrent strokes or heart attacks, adding to the treatments we already have.”
Insulin resistance is a common condition that affects about one of every four people. It is especially common in people who are older, inactive or overweight. Insulin resistance has recently been determined to cause atherosclerosis, the underlying disease that clogs vessels in strokes and heart attacks.
People who are insulin resistant are unable to efficiently metabolize sugar, the key energy source for the body. Pioglitazone allows these individuals to better metabolize sugar.
The IRIS Trial is being funded by the National Institute of Neurological Disorders and Stroke (NINDS), one of the divisions of the National Institutes of Health (NIH). It was originally funded for five years and $28 million. It was recently renewed for another five years and about $20 million, Dr. Kernan said.
He anticipates that the study will conclude in 2014 and results will then be published in a major scientific journal.
“Clinical research is essential in finding new treatments and improving outcomes,” Dr. Fayad said. He noted that more than $70 billion per year is spent on stroke-related health care in the United States each year.
Although the cost of the trial is high, Dr. Kernan said the benefits derived could far exceed the cost. “If the drug reduces the number of recurrent strokes, it will result in huge cost savings in addition to a tremendous reduction in patient suffering,” he said. “The benefits will be felt not only in the United States but across the world.”
UNMC is the only public health science center in the state. Its educational programs are responsible for training more health professionals practicing in Nebraska than any other institution. Through their commitment to education, research, patient care and outreach, UNMC and its hospital partner, The Nebraska Medical Center, have established themselves as one of the country’s leading centers in cancer, transplantation biology, bioterrorism preparedness, neurodegenerative diseases, cardiovascular diseases, genetics, biomedical technology and ophthalmology. UNMC’s research funding from external sources now exceeds $82 million annually and has resulted in the creation of more than 2,600 highly skilled jobs in the state. UNMC’s physician practice group, UNMC Physicians, includes 513 physicians in 50 specialties and subspecialties who practice primarily in The Nebraska Medical Center. For more information, go to UNMC’s Web site at www.unmc.edu.