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| | Data From Correction Of Hemoglobin And Outcomes In Renal Insufficiency CHOIR |
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date: Apr 21st 2006 19:11
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Study Presented At National Kidney Foundation Meeting. Study Reinforces Hemoglobin Target Guidance in Approved PROCRIT® (Epoetin alfa) Label.
Final data from an investigational clinical trial, Correction of Hemoglobin and Outcomes in Renal Insufficiency, referred to as the CHOIR study, were presented today at the National Kidney Foundation (NFK) 2006 Spring Clinical Meetings. The study was conducted to understand whether anemic patients with chronic kidney disease (CKD) not on dialysis, treated with PROCRIT® (Epoetin alfa) to an investigational target hemoglobin level of 13.5 grams per deciliter of blood (g/dL), had improved mortality and specific cardiovascular outcomes compared to patients treated to a target hemoglobin level of 11.3 g/dL.
The primary analysis of the composite endpoint showed no improvement in mortality or cardiovascular outcomes when PROCRIT® was used to treat patients with anemia related to CKD not on dialysis to a hemoglobin level of 13.5 g/dL. The analysis showed a statistically significant higher incidence of composite endpoint events – consisting of mortality, stroke, heart attack and hospitalization due to congestive heart failure – in the group of patients treated to the investigational hemoglobin target of 13.5 g/dL, as compared to the group treated to the hemoglobin target that is consistent with the current product label, 11.3 g/dL.
The results of this study reinforce the guidance in the approved product label not to exceed the recommended target hemoglobin of 12 g/dL in anemic patients with CKD not on dialysis. The labeling for PROCRIT® recommends target hemoglobin levels of 10 to 12 g/dL in anemic patients with CKD not on dialysis. The current National Kidney Foundation guidelines recommend patients be treated to a target hemoglobin level of 11 to 12 g/dL.
When used according to product labeling, PROCRIT® has been shown over more than a decade of use to be a safe and effective treatment for the management of anemia in patients with CKD not on dialysis.
About CHOIR
A total of 1,432 patients in 130 U.S. sites were enrolled in the study. The primary endpoint was a composite endpoint. The composite endpoint was a combination of mortality and cardiovascular outcomes: stroke, myocardial infarction and hospitalization due to congestive heart failure. Two hundred and twenty-two composite endpoint events occurred in the study up to its termination 125 events in the 13.5 g/dL arm and 97 events in the 11.3 g/dL arm. The difference in the number of composite endpoint events was statistically significant. One hundred and twenty-eight patients died during the study and the 90-day study follow-up period: 72 patients in the arm being treated to 13.5 g/dL and 56 patients in the arm being treated to 11.3 g/dL. However, the difference in the number of patients who died between the two treatment arms is not statistically significant. The study investigators did not report an association between the reported deaths and the use of PROCRIT®. The study was terminated in May 2005 upon recommendation of its data safety monitoring board. Results of the study have been reported to regulatory authorities.
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