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Duke University Medical Center was awarded $16 million by the National Institute on Aging to form a consortium of the nation’s leading experts to investigate why unexplained anemia is so common in older adults.

During the next six years, they will conduct clinical trials and translational studies with the goal of developing better treatments.

To date, little to no research has focused on unexplained anemia which accounts for one-third of cases in the elderly.

"The population has been difficult to define and it has been challenging to enroll participants in clinical trials," says Harvey J. Cohen, MD, director of the Center for the Study of Aging at Duke, who will serve as the overall principal investigator of the consortium, known as Partnership for Anemia: Clinical and Translational Trials in the Elderly (PACTTE).

"The lack of information geriatricians and nephrologists have about the underlying causes of unexplained anemia have been a major barrier for testing treatment strategies," he adds.

Anemia affects about 11 percent of adults over the age of 65, according to the Third National Health and Nutrition Examination Survey (NHANES III). The incidence rises to 20 percent of elderly over 85 years of age who live independently, and approaches 50 percent for those who are hospitalized or institutionalized.

Two-thirds of anemia cases can be attributed to nutritional deficiencies or an underlying medical condition like kidney disease.

The ramifications of unexplained anemia are significant, says Lynda Szczech, MD, associate professor of medicine at the Duke Clinical Research Institute (DCRI) which will coordinate the grant's clinical operations.

It's been associated with increased mortality, hospitalization, higher incidence and more severe cardiovascular disease, cognitive impairment, decreased physical function, and an increased risk of falls and fractures.

"The area of anemia management has been controversial and tumultuous over the last few years with several trials demonstrating rather unexpected results," says Szczech who will serve as the principal investigator of the coordinating center (DCRI). She will work with the clinical sites at the University of Chicago, Stanford University, UCLA, Case Western University, Johns Hopkins University, Howard University and the University of Utah.

"This consortium is poised to address these results and understand the impact of correcting anemia in a truly vulnerable population."

"There are many reasons why older people are substantially under-represented in clinical trials," says Cohen. "Physicians are sometimes reluctant to refer older people, patients may not be interested in traveling to centers where trials are conducted, or this age cohort may fear they are being 'experimented on.'"

Anemia trials present an even greater challenge because people don’t generally consider it a life-threatening problem. "It's been under-appreciated as a potential cause for both adverse effects on survival and quality of life," he adds.

The consortium plans to overcome these obstacles by creating a network of centers comprising the nation’s most recognized experts in anemia and gerontology with demonstrated success at recruiting patients to trials.

The first trial will look at currently available information and test an agent already approved for use in anemia. Erythropoiesis stimulating agents (ESA) are used routinely in anemia associated with chronic kidney disease, cancer, and other conditions, but not in unexplained anemia.

Studies demonstrate the treatment is effective at improving cognitive and heart function in some populations, but not enough studies have been done in older adults and they are often discontinued early because of poor accrual. Also, the treatment is not without risks. ESA has been linked to hypertension and increased risk of blood clotting.

The resulting data on this initial trial and others will help the Consortium develop diagnostic criteria and treatment guidelines that will become the gold standard and form the basis for future studies designed to address anemia treatment in older adults.

"With this grant, the government has challenged us to lay the groundwork for what's needed," Cohen says. "By bringing together the best minds in geriatrics, hematology, and nephrology, we hope to shed light on the prevalence of unexplained anemia, and quickly translate our current clinical and translational knowledge into a series of well-designed clinical trials."

The PACCTE members include: Harvey Cohen, MD, Duke University Medical Center, Andy Artz, MD, University of Chicago co- principal investigator, Stan Schrier, MD Consortium Chair Stanford University, Lynda Szczech, MD, Duke University Medical Center, Huiman Barnart, PhD, Duke University Medical Center, David  Reuben, MD, University of California at Los Angeles, Elizabeth Price, MD, Stanford University, Nathan Berger, MD, Case Western Reserve University, Jeremy Walston, MD, Johns Hopkins University, Victor Gordeuk, MD, Howard University, Neeraj Agarwal, MD, University of Utah, Josef Prchal, MD, University of Utah, and NIA representatives.