Roche Pharmaceuticals

CREATE Study Answers Key Question on Anaemia Management in Chronic Kidney Disease

    Basel, Switzerland, November 16 (ots/PRNewswire) -

    - New England Journal of Medicine Article Shows no Additional Cardiac Benefit From Increasing Haemoglobin to Levels Outside Current Recommendations

    The long awaited results of CREATE (i), a landmark trial that investigated a key question in nephrology, were published today. CREATE set out to see if there was additional cardiovascular benefit in treating anaemia in patients with chronic kidney disease (CKD) to a haemoglobin level as seen in healthy individuals. The CREATE results clearly show that there is no additional cardiovascular benefit from treating to higher haemoglobin levels in this patient group.[1] CREATE confirms the current anaemia treatment recommendations of treating to a sub-normal level of haemoglobin and supports the use of NeoRecormon(R) (epoetin beta) within its current label. These recommendations are in line with the consensus of the European Best Practice Guidelines (see Notes to Editors) for all ESAs (Erythropoiesis Stimulating Agents) like epoetins and darbepoetin alfa.

    Anaemia is an almost universal complication of renal disease. More patients with chronic kidney disease not yet on dialysis die from cardiovascular problems than progress to end stage renal disease.[2] Previous studies have suggested that treating anaemia with epoetin may improve cardiac outcome. However, the optimal target haemoglobin range in patients with different stages of chronic kidney disease and with mild to moderate anaemia has not been determined.

    CREATE was the first prospective study completed to date to look at anaemia treatment and cardiovascular outcomes in patients with chronic kidney disease not on dialysis. CREATE was designed to answer the important question of whether complete correction of anaemia improves cardiovascular outcomes in this patient group compared to partial anaemia correction and maintenance of haemoglobin at lower sub-normal levels consistent with current recommendations.

    "The vast majority of patients with chronic kidney disease have anaemia which puts them at high risk of developing cardiovascular problems. It is therefore reassuring to confirm that we are already delivering optimal care for patients with mild to moderate anaemia by treating in line with current clinical experience and guidelines." commented CREATE principle investigator, Professor Tilman Drüeke of the Necker Hospital, Paris, France.

    About the CREATE study:

    The study involved 603 patients with early (stages 3-4) chronic kidney disease and mild anaemia (haemoglobin 11.0 to 12.5 g/dL). Patients were randomized to receive NeoRecormon(R) (epoetin beta) at a starting dose of 2000 IU to correct haemoglobin levels to either 13-15 g/dL (normal 'complete' correction, Group 1) or 10.5-11.5 g/dL (sub-normal 'partial' correction, Group 2). Subcutaneous NeoRecormon(R) (epoetin beta) was initiated at randomization (Group 1) or when haemoglobin fell below 10.5 g/dL (Group 2). Patients were followed up for between 2-4 years.

    Key results:

    - Early anaemia correction to higher haemoglobin levels did not alter the time to the primary composite endpoint of eight cardiovascular events over the study period.

    - There were no significant differences in all-cause mortality or cardiovascular mortality between the study groups. Overall, the cardiovascular event rate in the study was lower than expected in both groups.

    - Left ventricular mass index (LVMI)(see Notes to Editors) remained stable, with no significant difference between the two haemoglobin target groups.

    - Patients from Group 1 experienced greater improvements in quality of life (general health and physical function).

    - The time to dialysis was shorter in Group 1 (127 vs. 111 events for Group 1 and 2 respectively, P=0.034). There was no significant difference in the change in mean eGFR (estimated Glomerular Filtration Rate, a measurement of renal function) between both groups. Initiation of dialysis resulted from the decision from the treating nephrologist with no protocol-specific criteria.

    - Overall, there were no major differences in adverse events between both groups.

    Key conclusion:

    The CREATE study results showed that that there is no additional cardiovascular benefit to be gained by treating pre-dialysis patients without significant left ventricular hypertrophy (LVH), to reach the normal haemoglobin range observed in healthy individuals and adds direct evidence that confirms current best practice guidelines and supports the use of NeoRecormon(R) within its current label for the treatment of anaemia.

    (i) Cardiovascular risk Reduction with Early Anaemia Treatment by Epoetin beta

    (R) NeoRecormon is a registered trademark of F. Hoffmann-La Roche and is legally protected. All trademarks used or mentioned in this release are legally protected. Full prescribing information is available upon request.

    Notes to Editors

    1. Patients whose kidneys are failing are unable to secrete erythropoietin, a protein that is produced by the kidneys and which stimulates the production of oxygen-bearing red blood cells in the bone marrow. As a consequence anaemia develops which causes cardiac ischaemia (lack of oxygen in the heart muscle). The lack of oxygen means that the heart has to work harder, which in turn leads to left ventricular hypertrophy (LVH).

    2. LVMI is a measurement of LVH, an irreversible condition featuring an enlarged, diseased heart. LVH can eventually lead to chronic heart failure (CHF), and other health problems.[3] [4]

    3. Current European (EBPG) and USA (NKF-K/DOQI) guidelines recommend that Hb in CKD patients should be at or greater than 11.0 g/dL. In the US, the guidelines caution when intentionally maintaining haemoglobin>13 g/dl. There is no specific maximum limit in the European guidelines.[5] [6]

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    [1] Drüeke et al. Effects of Normalizing Hemoglobin in Chronic Kidney Disease Patients. NEJM 2006, 355: 2071-84

    [2] Dirks JH et al. Kidney Int Suppl. 2005. 68:s1-6.

    [3] Collins AJ. Anaemia management prior to dialysis: cardiovascular and cost-benefit observations. Nephrol Dial Transplant. 2003. 18(Suppl 2): ii2-ii6

    [4] Levin A et al. Prevalent left ventricular hypertrophy in the predialysis population: identifying opportunities for intervention. Am J Kidney Dis. 1996. 27:347-354

    [5] Revised European Best Practice Guidelines for the Management of Anaemia in Patients with Chronic Renal Failure. Nephrol Dial Transplant. 2004; 19: [Suppl 2].

    [6] NKF-K/DOQI Clinical practice guidelines and clinical practice recommendations for anaemia in chronic kidney disease. Am J Kidney Dis 2006; 47(5 Suppl 3): S11-S15.

ots Originaltext: Roche Pharmaceuticals
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For further information please contact Dr Corinne Fründt at Roche,
Tel: +41-61-687-0236, Mobile: +41-79-593-7216. Dr Diane Lorton at
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