The grant reflects a multidisciplinary and community effort that includes the University's College of Pharmacy, School of Nursing, School of Public Health and the Medical School, as well as several health care organizations in Minnesota and across the country. Leading the research team are principal investigator Ilo Leppik, M.D., clinical professor of pharmacy and neurology at the University of Minnesota and director of research for MINCEP® Epilepsy Care, and co-principal investigator James Cloyd, Pharm.D., associate dean of research and professor in the College of Pharmacy.
"When all is said and done, we hope this study leads to more individualized care for seniors with epilepsy and those receiving AEDs - care that takes into consideration a patient's age, gender, race, biology and other conditions," said Leppik. "To accomplish this, we have to involve different people from different disciplines who want to come together for a greater common good."
The need for that greater common good, according to Leppik, is made more pressing by America's fast-growing senior population - people over the age of 65 - are two to three times more likely to develop epilepsy than a younger person.
"Sixty or 70 years ago, the average adult only lived to their mid-50s. Now, life expectancy is in the 70s, which means we're seeing a greater occurrence of diseases that come with old age, including epilepsy," said Leppik. "It's possible that seniors always had a higher rate of epilepsy, we just didn't know it because people didn't live that long."
Epilepsy is defined as a chronic condition characterized by two or more recurrent, unprovoked seizures. Its onset in seniors is most often caused by stroke. Antiepileptic drugs are also used to treat other conditions, such as tremors and aggressive behavior disorders.
According to Cloyd, the traditional approach to treating epilepsy has been a "one-size-fits-all" strategy that the University research team believes may contribute to overmedication of seniors.
"Thirty years ago, you only had two AEDs and everyone received the same dose of the same drug. It was easy to either over- or undermedicate patients," said Cloyd. "In our recent research we've seen how different the elderly are from younger patients with respect to the amount of medication needed to produce optimal effects."
The research will be divided into four projects, which will run concurrently for five years. The projects will focus on patient responses to medication, drug metabolism, population variations, and potential correlations between overmedication and the occurrence of falls, fractures, depression, and decline in cognitive capabilities.
According to Cloyd and Leppik, this study is the first to examine in a comprehensive way how age, race, gender, genetic makeup, and other factors affect how seniors absorb and metabolize AEDs and the outcome of AED therapy. This is important because irregular absorption could increase the risk of having a seizure while a slower rate of metabolism could contribute to overmedication.
The research teams will also capitalize on a new and powerful research tool called population pharmacokinetics, which will help them learn about diverse populations by harnessing the results of routine medical care.
Researchers will use population pharmacokinetics to analyze the extensive patient database from Beverly Nursing Homes for treatment patterns and patient responses and correlations between these responses and patient characteristics. This approach can help researchers more quickly bridge the gap between their findings and the general population because of the large sample size and the number of research factors that can be studied, which means that findings can be more easily extrapolated to a broader audience.
According to Leppik, the grant -- which was ranked in the top 2 percent of all NIH grants based on its potential medical merits -- builds on work that was done through a previous NIH grant for epilepsy research that extended from 1997 to 2002. Results of that research are currently being published in various research journals.