Roche Pharmaceuticals

First Study in Real-Life Setting Confirms That Once-Monthly Mircera Keeps Haemoglobin Levels Within a Tight Range

    Basel, Switzerland, November 10 (ots/PRNewswire) -

    - Results Demonstrate Effective and Simplified Approach to Anaemia  Management in Chronic Kidney Disease Patients on Dialysis

    Interim study results from 90 renal centres in Germany confirm for the first time that in a real-life setting Mircera(R) maintains haemoglobin (Hb) levels within a narrow range when chronic kidney disease (CKD) patients receiving dialysis are switched to once-monthly Mircera from commonly used and frequently dosed erythropoiesis-stimulating agents (ESAs)(1).

    Multimedia News Release: http://www.prnewswire.com/mnr/mircera/35922/

    The data, presented at the 41st Annual Meeting of the American Society of Nephrology (ASN - http://www.asn-online.org/ ) in Philadelphia, highlights Mircera's ability to keep Hb stable with simple once-monthly dosing. Keeping Hb in a narrow target range has become a hot issue for health authorities in the last year with international guidelines recommending it be kept between 11-12 g/dL. It is recognized that CKD patients are at a higher risk of death or hospitalization when their Hb fluctuates outside the recommended range  (2). Keeping Hb within this narrow range however is a challenge with many patients experiencing Hb fluctuations; a previous study has shown that over a six month period only 6.5% of patients (on dialysis) had Hb which stayed in a target range of 11-12.5g/dL (3, 4).

    Dr Danilo Fliser of the Saarland University Medical Centre, Homburg, Germany and investigator for the MIRACEL study group who presented the data  said "Across the many centres involved in the Miracel study physicians were  administering four different ESAs with different dosing schedules and it is  gratifying to see that when we simply switch to Mircera given once-a-month,  we can effectively and safely manage anaemia. I believe this may offer  physicians and nurses the opportunity to save time that can be redirected  to optimizing patient care."

    About the study:

    The MIRACEL study is a multi-centre single arm study involving 422 patients from 90 dialysis centres across Germany treated with once-monthly Mircera. It is the first study using real-life data to look at the impact of Hb stability following directly switching dialysis patients from shorter-acting ESAs to once-monthly Mircera.

    - The data presented were from the first 140 patients who had been previously treated with either epoetin alfa, beta or delta or darbepoetin alfa, administered three times a week (TIW) or once every two weeks (Q2W) either intravenously or subcutaneously and who were switched to once-monthly Mircera (QM) administered intravenously via pre-filled syringes.

    - During the study evaluation phase (month 7, 8 and 9) the majority of patients (84%) had stable Hb levels (less than or equal to, plus or minus  1 g/dL deviation from the individual mean).

    - The median Mircera dose (125 micro g QM) was the same at the start of the titration period and at the end of the evaluation period.

    - Mircera was generally well tolerated, with a safety profile similar to that reported in all the Mircera Phase III studies. All the patients had some underlying illnesses, with 30% having diabetes.

    Managing CKD is very time consuming, with physicians handling many other conditions in addition to anaemia, including high blood pressure, high cholesterol, cardiovascular disease and diabetes. A simplified approach to anaemia care could offer potential time saving benefits for healthcare staff and more convenience for patients (5). Modelling data presented at the ERA-EDTA conference in Barcelona last year showed that it may be possible to cut nearly in half the annual time spent on anaemia management in a dialysis centre by using a once-monthly anaemia agent(6).

    About Mircera:

    Mircera, the first continuous erythropoietin receptor activator indicated for the treatment of symptomatic anaemia in chronic kidney disease, is now approved in 68 countries and launched in 49 including the major EU markets Germany, the UK, Spain and France. It has a different receptor interaction and longer half-life than other ESAs which allows for sustained and predictable anaemia management(7, 8, 9). Mircera's method of administration is simple: it is the only ESA approved in the EU to correct anaemia with an immediate once-every-two-week treatment schedule in all CKD patient types (those on or not on dialysis) with either an IV or SC dose. CKD patients on dialysis or not, on any ESA, can then be directly switched to a once-monthly maintenance schedule. This ability to switch patients directly has the potential to simplify anaemia management(6).

    About Roche:

    Information about the Roche Group is available on the Internet at http://www.roche.com

    Editor's Notes

    For more information about the trial please go to: http://www.roche-trials.com/patient/trials/trial110715.html

    Additional information about renal anaemia is available on the Internet at http://www.AnaemiaWorld.com and http://www.lifeblood.anaemiaworld.com

    The Mircera(R) logo and film clips about renal anaemia treatment are available for media on the Internet at http://www.thenewsmarket.com

    References

    (1) Fliser et al ASN 2008 abstract 553648. Once Monthly C.E.R.A. Provides Stable Hb Levels in CKD Patients On Dialysis Following Direct Switch From Short Acting ESAs.

    (2) Gilbertson D. T. et al. Hemoglobin Level Variability: Associations with Mortality. Clin J Am Soc Nephrol 3: 133-138, 2008

    (3) Fishbane S. and Berns J. S. Kidney International. 2005; 68/3:1337.

    (4) Ebben J. P, et al. J. Clin J Am Soc Nephrol. 2006; 1: 1205 - 1210.

    (5) Macdougall I, et al. C.E.R.A. Corrects Anemia in Patients with Chronic Kidney Disease not on Dialysis: Results of a Randomized Clinical Trial. CJASN, 2008; 3 (2) 337-347

    (6) Ulrich Saueressig, et al. Staff time and costs for anaemia management with erythropoietic stimulating agents in patients on haemodialysis. Abstract SaP341 44th ERA-EDTA Barcelona 2007

    (7) MIRCERA(R) Summary of Product Characteristics. F. Hoffmann-La Roche Ltd, 2007

    (8) Sulowicz W, Locatelli F, Ryckelynck J-P, et al. Once-monthly subcutaneous C.E.R.A. maintains stable hemoglobin control in patients with chronic kidney disease on dialysis and converted directly from epoetin one to three times weekly. Clin J Am Soc Nephrol. 2007;2:637-646

    (9) Jarsch M, Brandt M, Haselbeck A. Consumption of C.E.R.A. and epoetin beta in a cellular assay: UT-7 consumption model. Presented at American Society of Hematology (ASH) 48th Meeting, December 9-12, 2006, Orlando, FL

      For further information please contact:
      Sheila Kolesaire at Roche        Diane Lorton at Galliard
      Tel: +973-235-4347                  Tel: +44-(0)207-663-2265
      Mobile: +973-687-0188              Mobile: +44-(0)7717-531-823

ots Originaltext: Roche Pharmaceuticals
Im Internet recherchierbar: http://www.presseportal.ch

Contact:
For further information please contact: Sheila Kolesaire at Roche,
Tel: +973-235-4347, Mobile: +973-687-0188; Diane Lorton at Galliard,
Tel: +44-(0)207-663-2265, Mobile: +44-(0)7717-531-823



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