Ortho Biotech Products, L.P. Release: Study Finds Patients With Moderate To Severe Chronic Kidney Disease Go Undiagnosed

PHILADELPHIA, Nov. 10 /PRNewswire/ -- Study results presented today at the American Society of Nephrology's 38th Annual Meeting and Scientific Exposition demonstrated that patients, particularly women, with moderate to severe chronic kidney disease are often undiagnosed and have a low rate of referral to nephrologists, a medical specialty focused on treating kidney-related disorders.

The study determined that among 85,172 patients, 2,454 had moderate to severe chronic kidney disease. Of these, only one-third had a diagnosis of chronic kidney disease. Additionally, approximately 75 percent of Stage 3 chronic kidney disease patients and 42 percent of Stage 4 patients did not have a formal diagnosis of the disease. The study also demonstrated that a disproportionately lower number of women with Stage 3 - 5 chronic kidney disease had been diagnosed (24 percent of women vs. 44 percent of men). In addition, the study found that both diagnosed and undiagnosed patients had a low referral rate to nephrologists, regardless of their disease stage or whether or not they suffered from diabetes and high blood pressure -- two risk factors for kidney disease.

"The analysis shows that many people with chronic kidney disease are not being accurately diagnosed and referred to medical specialists," explained the study's lead author Ajay Singh, MD, Renal Division, Brigham and Women's Hospital, Boston, MA. "This makes it so important that those with high risk factors for chronic kidney disease -- hypertension and diabetes -- learn to recognize early warning signs of the condition, such as anemia, and take an active role in their health care."

This study was designed to determine the connection between claims data in a managed care setting and the use of estimated glomerular filtration rates, referred to as eGFR, in diagnosing chronic kidney disease. eGFR is a test to measure kidney function and stage of kidney disease. Physicians calculate eGFR based on age, race, gender and the results of blood creatinine tests, which measure how well the kidneys are working. The study also was designed to quantify gender disparities in identification and coding of chronic kidney disease patients and to determine what type of medical specialists chronic kidney disease patients are referred to within a managed care organization.

The National Kidney Foundation and National Kidney Disease Education Program have emphasized the importance of physicians using eGFR rates to diagnose chronic kidney disease early. The inclusion of eGFR on lab reports, along with education, may help primary care physicians better diagnose, treat, and refer patients.

Study Methodology

Demographics, claims and lab data from 2004 of enrollees in a managed care organization, Horizon Healthcare Services, Inc., were examined. Patient identities were not known. After excluding end-stage renal disease patients, eGFR was calculated for 85,172 patients and the analysis focused on patients with moderate to severe chronic kidney disease.

Patients were diagnosed according to the Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines published in 2002 by the National Kidney Foundation for the classification and diagnosis of chronic kidney disease, identified through the International Classification of Diseases, Ninth Revision, Clinical Modification codes -- known as ICD-9-CM. Based on the World Health Organization's Ninth Revision, ICD-9-CM is the official system of assigning codes to diagnoses and procedures associated with hospital utilization in the United States.

Ortho Biotech Products, L.P., the marketer of PROCRIT(R) (Epoetin alfa), supported the study. Dr. Singh, principal investigator of the study, is a consultant to Ortho Biotech Clinical Affairs, L.L.C.

About Ortho Biotech Products, L.P.

In 1990, Ortho Biotech Products, L.P. was established in Raritan, N.J. Since that time, Ortho Biotech and its worldwide affiliates have earned a global reputation for researching, manufacturing and marketing innovative products that enhance patients' health. Ortho Biotech, located in Bridgewater, N.J., is an established market leader in Epoetin alfa therapy for anemia management.

Ortho Biotech, in partnership with leading patient and professional organizations, introduced http://www.KidneyResource.com, a comprehensive directory of chronic kidney disease sites on the World Wide Web. This site provides physicians, patients and caregivers immediate access to more than 60 Web sites, many of which are operated by non-profit, educational and patient advocacy organizations. The site also offers an interactive anemia awareness center, which features information about anemia related to chronic kidney disease.

Ortho Biotech Products, L.P.

CONTACT: Stephanie Fagan of Ortho Biotech Products, L.P., office:+1-908-541-4029 or cell: +1-201-572-9581, sfaganoe@gpcus.jnj.com, LeanneMadison of Ogilvy Public Relations Worldwide, office: +1-212-880-5246 orcell: +1-857-205-8415, leanne.madison@ogilvypr.com

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