Magazin
2008-11-10
Basel, Switzerland, November 10 (ots/PRNewswire) -
- Results Demonstrate Effective and Simplified Approach toAnaemia Management in Chronic Kidney Disease Patients on Dialysis
Interim study results from 90 renal centres in Germany confirmfor the first time that in a real-life setting Mircera(R) maintainshaemoglobin (Hb) levels within a narrow range when chronic kidneydisease (CKD) patients receiving dialysis are switched toonce-monthly Mircera from commonly used and frequently dosederythropoiesis-stimulating agents (ESAs)(1).
Multimedia News Release:http://www.prnewswire.com/mnr/mircera/35922/
The data, presented at the 41st Annual Meeting of the AmericanSociety of Nephrology (ASN - http://www.asn-online.org/ ) inPhiladelphia, highlights Mircera's ability to keep Hb stable withsimple once-monthly dosing. Keeping Hb in a narrow target range hasbecome a hot issue for health authorities in the last year withinternational guidelines recommending it be kept between 11-12 g/dL.It is recognized that CKD patients are at a higher risk of death orhospitalization when their Hb fluctuates outside the recommendedrange (2). Keeping Hb within this narrow range however is achallenge with many patients experiencing Hb fluctuations; a previousstudy 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 whopresented the data said "Across the many centres involved in theMiracel study physicians were administering four different ESAs withdifferent dosing schedules and it is gratifying to see that when wesimply switch to Mircera given once-a-month, we can effectively andsafely manage anaemia. I believe this may offer physicians andnurses the opportunity to save time that can be redirected tooptimizing patient care."
About the study:
The MIRACEL study is a multi-centre single arm study involving422 patients from 90 dialysis centres across Germany treated withonce-monthly Mircera. It is the first study using real-life data tolook at the impact of Hb stability following directly switchingdialysis patients from shorter-acting ESAs to once-monthly Mircera.
- The data presented were from the first 140 patients who hadbeen previously treated with either epoetin alfa, beta or delta ordarbepoetin alfa, administered three times a week (TIW) or once everytwo weeks (Q2W) either intravenously or subcutaneously and who wereswitched to once-monthly Mircera (QM) administered intravenously viapre-filled syringes.
- During the study evaluation phase (month 7, 8 and 9) themajority of patients (84%) had stable Hb levels (less than or equalto, plus or minus 1 g/dL deviation from the individual mean).
- The median Mircera dose (125 micro g QM) was the same at thestart of the titration period and at the end of the evaluationperiod.
- Mircera was generally well tolerated, with a safety profilesimilar to that reported in all the Mircera Phase III studies. Allthe patients had some underlying illnesses, with 30% having diabetes.
Managing CKD is very time consuming, with physicians handlingmany other conditions in addition to anaemia, including high bloodpressure, high cholesterol, cardiovascular disease and diabetes. Asimplified approach to anaemia care could offer potential time savingbenefits for healthcare staff and more convenience for patients (5).Modelling data presented at the ERA-EDTA conference in Barcelona lastyear showed that it may be possible to cut nearly in half the annualtime spent on anaemia management in a dialysis centre by using aonce-monthly anaemia agent(6).
About Mircera:
Mircera, the first continuous erythropoietin receptor activatorindicated for the treatment of symptomatic anaemia in chronic kidneydisease, is now approved in 68 countries and launched in 49 includingthe major EU markets Germany, the UK, Spain and France. It has adifferent receptor interaction and longer half-life than other ESAswhich allows for sustained and predictable anaemia management(7, 8,9). Mircera's method of administration is simple: it is the only ESAapproved in the EU to correct anaemia with an immediateonce-every-two-week treatment schedule in all CKD patient types(those on or not on dialysis) with either an IV or SC dose. CKDpatients on dialysis or not, on any ESA, can then be directlyswitched to a once-monthly maintenance schedule. This ability toswitch patients directly has the potential to simplify anaemiamanagement(6).
About Roche:
Information about the Roche Group is available on the Internet athttp://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 theInternet at http://www.AnaemiaWorld.com andhttp://www.lifeblood.anaemiaworld.com
The Mircera(R) logo and film clips about renal anaemia treatmentare available for media on the Internet athttp://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 FollowingDirect 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 Patientswith Chronic Kidney Disease not on Dialysis: Results of a RandomizedClinical Trial. CJASN, 2008; 3 (2) 337-347
(6) Ulrich Saueressig, et al. Staff time and costs for anaemiamanagement with erythropoietic stimulating agents in patients onhaemodialysis. Abstract SaP341 44th ERA-EDTA Barcelona 2007
(7) MIRCERA(R) Summary of Product Characteristics. F. Hoffmann-LaRoche Ltd, 2007
(8) Sulowicz W, Locatelli F, Ryckelynck J-P, et al. Once-monthlysubcutaneous C.E.R.A. maintains stable hemoglobin control in patientswith chronic kidney disease on dialysis and converted directly fromepoetin 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. andepoetin beta in a cellular assay: UT-7 consumption model. Presentedat 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 PharmaceuticalsIm Internet recherchierbar: http://www.presseportal.de
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
First Study in Real-Life Setting Confirms That Once-Monthly Mircera Keeps Haemoglobin Levels Within a Tight Range
- Results Demonstrate Effective and Simplified Approach toAnaemia Management in Chronic Kidney Disease Patients on Dialysis
Interim study results from 90 renal centres in Germany confirmfor the first time that in a real-life setting Mircera(R) maintainshaemoglobin (Hb) levels within a narrow range when chronic kidneydisease (CKD) patients receiving dialysis are switched toonce-monthly Mircera from commonly used and frequently dosederythropoiesis-stimulating agents (ESAs)(1).
Multimedia News Release:http://www.prnewswire.com/mnr/mircera/35922/
The data, presented at the 41st Annual Meeting of the AmericanSociety of Nephrology (ASN - http://www.asn-online.org/ ) inPhiladelphia, highlights Mircera's ability to keep Hb stable withsimple once-monthly dosing. Keeping Hb in a narrow target range hasbecome a hot issue for health authorities in the last year withinternational guidelines recommending it be kept between 11-12 g/dL.It is recognized that CKD patients are at a higher risk of death orhospitalization when their Hb fluctuates outside the recommendedrange (2). Keeping Hb within this narrow range however is achallenge with many patients experiencing Hb fluctuations; a previousstudy 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 whopresented the data said "Across the many centres involved in theMiracel study physicians were administering four different ESAs withdifferent dosing schedules and it is gratifying to see that when wesimply switch to Mircera given once-a-month, we can effectively andsafely manage anaemia. I believe this may offer physicians andnurses the opportunity to save time that can be redirected tooptimizing patient care."
About the study:
The MIRACEL study is a multi-centre single arm study involving422 patients from 90 dialysis centres across Germany treated withonce-monthly Mircera. It is the first study using real-life data tolook at the impact of Hb stability following directly switchingdialysis patients from shorter-acting ESAs to once-monthly Mircera.
- The data presented were from the first 140 patients who hadbeen previously treated with either epoetin alfa, beta or delta ordarbepoetin alfa, administered three times a week (TIW) or once everytwo weeks (Q2W) either intravenously or subcutaneously and who wereswitched to once-monthly Mircera (QM) administered intravenously viapre-filled syringes.
- During the study evaluation phase (month 7, 8 and 9) themajority of patients (84%) had stable Hb levels (less than or equalto, plus or minus 1 g/dL deviation from the individual mean).
- The median Mircera dose (125 micro g QM) was the same at thestart of the titration period and at the end of the evaluationperiod.
- Mircera was generally well tolerated, with a safety profilesimilar to that reported in all the Mircera Phase III studies. Allthe patients had some underlying illnesses, with 30% having diabetes.
Managing CKD is very time consuming, with physicians handlingmany other conditions in addition to anaemia, including high bloodpressure, high cholesterol, cardiovascular disease and diabetes. Asimplified approach to anaemia care could offer potential time savingbenefits for healthcare staff and more convenience for patients (5).Modelling data presented at the ERA-EDTA conference in Barcelona lastyear showed that it may be possible to cut nearly in half the annualtime spent on anaemia management in a dialysis centre by using aonce-monthly anaemia agent(6).
About Mircera:
Mircera, the first continuous erythropoietin receptor activatorindicated for the treatment of symptomatic anaemia in chronic kidneydisease, is now approved in 68 countries and launched in 49 includingthe major EU markets Germany, the UK, Spain and France. It has adifferent receptor interaction and longer half-life than other ESAswhich allows for sustained and predictable anaemia management(7, 8,9). Mircera's method of administration is simple: it is the only ESAapproved in the EU to correct anaemia with an immediateonce-every-two-week treatment schedule in all CKD patient types(those on or not on dialysis) with either an IV or SC dose. CKDpatients on dialysis or not, on any ESA, can then be directlyswitched to a once-monthly maintenance schedule. This ability toswitch patients directly has the potential to simplify anaemiamanagement(6).
About Roche:
Information about the Roche Group is available on the Internet athttp://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 theInternet at http://www.AnaemiaWorld.com andhttp://www.lifeblood.anaemiaworld.com
The Mircera(R) logo and film clips about renal anaemia treatmentare available for media on the Internet athttp://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 FollowingDirect 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 Patientswith Chronic Kidney Disease not on Dialysis: Results of a RandomizedClinical Trial. CJASN, 2008; 3 (2) 337-347
(6) Ulrich Saueressig, et al. Staff time and costs for anaemiamanagement with erythropoietic stimulating agents in patients onhaemodialysis. Abstract SaP341 44th ERA-EDTA Barcelona 2007
(7) MIRCERA(R) Summary of Product Characteristics. F. Hoffmann-LaRoche Ltd, 2007
(8) Sulowicz W, Locatelli F, Ryckelynck J-P, et al. Once-monthlysubcutaneous C.E.R.A. maintains stable hemoglobin control in patientswith chronic kidney disease on dialysis and converted directly fromepoetin 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. andepoetin beta in a cellular assay: UT-7 consumption model. Presentedat 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 PharmaceuticalsIm Internet recherchierbar: http://www.presseportal.de
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
Roche Pharmaceuticals
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