U. of Maryland School of Pharmacy Hopes to Close Clinical Gap for Elderly Blood Disorder

Newswise - The National Institutes of Health has awarded a competitive grant of more than $777,000 to University of Maryland School of Pharmacy and Johns Hopkins University researchers to study the costs, risks, and benefits of treatments for blood disorders that affect more than 10,000 elderly patients each year.

The challenge grant targets a widely accepted practice of controlling anemia that is associated with myelodysplastic syndromes (MDS) with erythropoietin, a hormone that controls red blood cell production. Such syndromes are sometimes called pre-leukemias.

Drugs called erythropoietin stimulating agents, or ESAs, are effective in treating anemia in MDS patients. However, little is known about the drugs' longer-term health effects. Myelodysplastic syndromes are the most common hematologic malignancies in the elderly.

"In this study, we will use data from regional cancer registries that are linked to Medicare enrollment and insurance claims data," says Amy Davidoff, PhD, research associate professor at the School of Pharmacy. "We will examine the characteristics of Medicare beneficiaries with MDS, patterns of treatment, safety and effectiveness of ESA use, and costs of care."

Doctors have treated MDS patients with ESAs to control anemia for about 15 years. This treatment has had a 20 to 40 percent response rate and median response duration of two years. However, there is a serious lack of large-scale clinical trial evidence supporting longer-term clinical benefits, according to Davidoff and co-grantees Sheila Weiss Smith, PhD, director of the Center for Drug Safety at the School of Pharmacy and professor at the University of Maryland schools of pharmacy and medicine, Maria Baer, MD, professor at the School of Medicine and director of the Hematologic Malignancies Program at the University of Maryland Marlene and Stewart Greenebaum Cancer Center, and Steven Gore, MD, professor at Hopkins' Sidney Kimmel Comprehensive Cancer Center.

In 2007 the Food and Drug Administration administered a warning about an apparent increase in thromboembolic events and a possible decrease in relapse-free survival when using ESAs for patients with cancer-related anemia, but there is an absence of large-scale randomized trials regarding MDS. The NIH grant is one of only 840 such grants awarded across the country after more than 20,000 applications.

Source: NewsWise