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Data From Ortho Biotech-Sponsored Studies to be Presented at National Kidney Foundation 2008 Spring Clinical Meetings

DALLAS, April 4, 2008 /PRNewswire/ -- Data from five studies sponsored by Ortho Biotech Products, L.P. will be presented at the National Kidney Foundation (NKF) 2008 Spring Clinical Meetings from April 2 - 6, 2008; three utilization studies involve PROCRIT(R) (Epoetin alfa).

The data include studies that compare drug utilization patterns and costs of PROCRIT (EPO) and darbepoetin alfa (DARB), evaluate medical costs related to chronic kidney disease (CKD) patients with hypertension or diabetes, and show the impact on hemoglobin (Hb) control using a software-based management tool. These retrospective analyses used data from actual clinical practice.

Data on Drug Utilization Patterns and Costs of Epoetin Alfa and Darbepoetin Alfa

-- Abstract: Assessment of Drug Utilization Patterns and Costs for

Erythropoietic Stimulating Agents in Patients with Chronic Kidney


Patrick Lefebvre, M.A., Groupe d'analyse, Ltee, Montreal, Quebec,


A retrospective analysis of medical claims was conducted using the

Ingenix Impact National Managed Care Database to examine recent EPO and

DARB treatment patterns and corresponding drug costs in newly-initiated

CKD patients treated with EPO (n=1,110) or DARB (n=723) not receiving

dialysis. Mean cumulative dose was used to calculate drug costs based

on October 2007 wholesale acquisition unit prices.

-- Abstract: Drug Utilization and Cost Considerations of Predialysis

Chronic Kidney Disease Patients Receiving Erythropoietic Stimulating

Agents Through Pharmacy Benefits

Francois Laliberte, M.A., Groupe d'analyse, Ltee, Montreal, Quebec,


A retrospective analysis of pharmacy claims using the PharMetrics

Patient-Centric Database, which represents approximately 85 managed

healthcare plans, was conducted to compare drug utilization patterns

and costs of a newly-initiated, managed care predialysis chronic kidney

disease population receiving EPO (n=1,066) or DARB (n=375) through a

pharmacy benefit. Drug cost was based on cumulative dose and October

2007 wholesale acquisition cost.

Data on Medical Costs Related to Chronic Kidney Disease Patients with Hypertension or Diabetes

-- Abstract: Medical Costs of Chronic Kidney Disease in Patients with

Diabetes: A Managed Care Perspective

Francois Laliberte, M.A., Groupe d'analyse, Ltee, Montreal, Quebec,


A retrospective analysis of medical claims and laboratory data from a

large managed care database was conducted to quantify the incremental

direct healthcare costs of CKD in patients with diabetes. Analyses

compared diabetes patients who developed CKD versus those who did not

for yearly direct healthcare costs, which consisted of outpatient

services, inpatient services and pharmacy dispensing claims. A total

of 30,480 patients with diabetes were identified, of whom 859 developed

CKD during the study period.

-- Abstract: The Effect of Anemia in Hypertensive Patients with Chronic

Kidney Disease: Hospital Costs and Length of Stay

Sandra Sulsky, M.P.H., Ph.D., ENVIRON International Corporation,

Amherst, MA

A retrospective analysis of hospital discharge records from the 2004

Nationwide Inpatient Sample of the Hospital Cost and Utilization

Project, which comprises approximately 90 percent of all hospital

discharges in the U.S., was conducted to determine the effect of anemia

on hospital costs and length of stay in hypertensive patients with CKD.

Analyses were adjusted for age, gender, income level, severity of

disease, and hospital characteristics to control for the confounding

effects of anemia, CKD and a combination of both on study outcomes.

Data on the Impact on Hemoglobin Control Using a Software-Based Management Tool

-- Abstract: Use of Epoetin Alfa in Maintaining Hemoglobin Control

Through a Software-Based Management Tool in a Community Nephrology


Craig Kleinmann, D.O., Nephrology Associates, Mobile, AL

A retrospective, observational chart review from a large U.S.

nephrology clinic was conducted in May 2007 to analyze the impact of

EPO on mean Hb over time as well as subsequent dose holds in anemic

non-dialysis CKD patients in a community practice setting using

TrakAnemia, a software-based tool. Eighty-seven patients who had a

documented diagnosis of anemia due to non-dialysis CKD, initiated EPO,

and had greater than or equal to six months of follow-up data were

included in the final analysis.

About PROCRIT (Epoetin alfa)

PROCRIT is used for the treatment of anemia in patients with most types of cancer receiving chemotherapy, with chronic renal failure who are on dialysis and those who are not on dialysis, who are being treated with zidovudine for HIV infection, and to reduce the need for transfusion in anemic patients who are scheduled for elective noncardiac, nonvascular surgery. Depending on the country in which Epoetin alfa is marketed, these indications may differ.

Important U.S. Safety Information for PROCRIT


Renal failure: Patients experienced greater risks for death and serious cardiovascular events when administered erythropoiesis-stimulating agents (ESAs) to target higher versus lower hemoglobin levels (13.5 vs. 11.3 g/dL; 14 vs. 10 g/dL) in two clinical studies. Individualize dosing to achieve and maintain hemoglobin levels within the range of 10 to 12 g/dL.


-- ESAs shortened overall survival and/or time-to-tumor progression in

clinical studies in patients with breast, non-small cell lung, head and

neck, lymphoid, and cervical cancers when dosed to target a hemoglobin

of greater than or equal to 12 g/dL.

-- The risks of shortened survival and tumor progression have not been

excluded when ESAs are dosed to target a hemoglobin of < 12 g/dL.

-- To minimize these risks, as well as the risk of serious cardio- and

thrombovascular events, use the lowest dose needed to avoid red blood

cell transfusions.

-- Use only for treatment of anemia due to concomitant myelosuppressive


-- Discontinue following the completion of a chemotherapy course.

Perisurgery: PROCRIT increased the rate of deep venous thromboses in patients not receiving prophylactic anticoagulation. Consider deep venous thrombosis prophylaxis.


PROCRIT is contraindicated in patients with uncontrolled hypertension or with known hypersensitivity to albumin (human) or mammalian cell-derived products.

Additional Important Safety Information

-- The dose of PROCRIT should be titrated for each patient to achieve and

maintain the following hemoglobin levels:

* Chronic renal failure patients - hemoglobin levels between 10 to 12

g/dL. If a patient does not attain hemoglobin levels of 10 to 12 g/dL

despite 12 weeks of appropriate PROCRIT therapy, see DOSAGE and

ADMINISTRATION in the PROCRIT Prescribing Information.

* Cancer or HIV patients - the lowest hemoglobin level sufficient to

avoid transfusion and not to exceed 12 g/dL.

-- Monitor hemoglobin regularly during therapy, more frequently following

a dosage adjustment or until hemoglobin becomes stable.

-- Cases of pure red cell aplasia (PRCA) and of severe anemia, with or

without other cytopenias, associated with neutralizing antibodies to

erythropoietin have been reported in patients with chronic renal

failure receiving PROCRIT by subcutaneous administration. If any

patient develops a sudden loss of response to PROCRIT, accompanied by

severe anemia and low reticulocyte count, and anti-erythropoietin

antibody-associated anemia is suspected, withhold PROCRIT and other

erythropoietic proteins. Contact ORTHO BIOTECH (1-888-2ASKOBI or

1-888-227-5624) to perform assays for binding and neutralizing

antibodies. If erythropoietin antibody-mediated anemia is confirmed,

PROCRIT should be permanently discontinued and patients should not be

switched to other erythropoietic proteins.

-- The safety and efficacy of PROCRIT therapy have not been established in

patients with a known history of a seizure disorder or underlying

hematologic disease (e.g., sickle cell anemia, myelodysplastic

syndromes or hypercoagulable disorders).

-- In some female patients, menses have resumed following PROCRIT therapy;

the possibility of pregnancy should be discussed and the need for

contraception evaluated.

-- Prior to and regularly during PROCRIT therapy monitor iron status;

transferrin saturation should be greater than or equal to 20% and

ferritin should be greater than or equal to 100 ng/mL. During therapy

absolute or functional iron deficiency may develop and all patients

will eventually require supplemental iron to adequately support

erythropoiesis stimulated by PROCRIT.

-- During PROCRIT therapy, blood pressure should be monitored carefully

and aggressively managed, particularly in patients with an underlying

history of hypertension or cardiovascular disease.

-- In studies, the most common side effects included fever (pyrexia),

diarrhea, nausea, vomiting, swelling of hands or feet (edema), lack or

loss of strength or weakness (asthenia, fatigue), shortness of breath,

high blood pressure, headache, joint pain (arthralgias), abnormal skin

sensations (as tingling or tickling or itching or burning;

paresthesia), rash, constipation and upper respiratory infection.

Please visit for the full Prescribing Information, including the Boxed WARNINGS.

About Ortho Biotech Products, L.P.

Ortho Biotech Products, L.P. is a leading biopharmaceutical company devoted to helping improve the lives of patients with cancer and with anemia due to multiple causes, including chronic kidney disease. Since it was founded in 1990, Ortho Biotech and its worldwide affiliates have earned a global reputation for researching, manufacturing and marketing innovative products that enhance patients' health. Located in Bridgewater, N.J., Ortho Biotech is an established market leader in Epoetin alfa therapy for anemia management. The company also markets treatments for recurrent ovarian cancer, rejection of transplanted organs and other serious illnesses. For more information, visit

SOURCE Ortho Biotech Products, L.P.
Copyright©2008 PR Newswire.
All rights reserved

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