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
-- 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,
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
-- 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
Boxed WARNINGS: INCREASED MORTALITY, SERIOUS CARDIOVASCULAR and THROMBOEMBOLIC EVENTS, and TUMOR PROGRESSION
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
-- 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
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
-- 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 http://www.procrit.com 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 http://www.orthobiotech.com.
|SOURCE Ortho Biotech Products, L.P.|
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