Roche's New ESA* Effectively Stabilises Haemoglobin Levels In Elderly Dialysis Patients
Challenges with traditional ESAs include fluctuating haemoglobin levels due to variations in erythropoietic activity. A phase III analysis of 1,245 patients across Europe, including patients from the UK, showed that elderly patients can be successfully switched from frequent-dosing ESAs to Roche's long-acting ESA with both intravenous and subcutaneous administration. The once-monthly ESA maintained stable haemoglobin levels from the initiation of treatment and was found to be well tolerated.
Dr Richard Fluck from Derby City General Hospital commented: "These results demonstrate that this ESA can be used effectively to treat anaemia in the older person with CKD. Elderly people are potentially fragile with a poorer prognosis because of the interaction between anaemia and other coexisting diseases. Renal anaemia worsens quality of life and has adverse outcomes. Sustainable treatment of renal anaemia using an effective ESA is vital in the management of these patients."
The prevalence of CKD patients on dialysis is a growing burden in the UK:
-- One tenth of the population may have CKD,4 with as many as 90% (100,000) affected by renal anaemia.5
-- More than 50% of patients on dialysis are over 60 years of age6 and this number is rising due to the ageing population and the current diabetes epidemic.2,3
-- The prevalence of CKD patients on dialysis is projected to grow by seven per cent every year and it is estimated that by 2010, there will be over two million people on dialysis worldwide.7
Catherine Johnson, newly elected president of the Anaemia Nurse Specialist Association (ANSA), commented: "With more elderly people requiring dialysis in the UK, doctors need effective medications that can improve the way we manage renal anaemia."
About the studies
-- The analysis is based on data from two phase III clinical trials, MAXIMA and PROTOS, which were part of the largest ever clinical development programme for a renal anaemia treatment.
-- 1,245 dialysis patients were randomised to remain on their current epoetin treatment administered up to three times a week or to be switched directly to Roche's long-acting ESA, administered by IV and SC either once every two or four weeks.
-- The results showed minimal changes from baseline to evaluation in mean haemoglobin (Hb) levels in patients 65 years (-0.18 vs -0.34 g/dL) as well as minimal changes with male and female patients (-0.21 vs -0.30 g/dL).
-- The study drug was well tolerated with a safety profile characteristic of the patient population.
Roche's ESA (methoxy polyethylene glycol-epoetin beta):
-- Is a long-acting ESA designed to mimic the action of erythropoietin, a hormone produced by the kidneys to stimulate red blood cell production, in order to make up for a shortage of the natural hormone in patients with renal anaemia.
-- Is currently in development for the treatment of renal anaemia in chronic kidney disease (CKD) patients either pre-dialysis or on dialysis.
-- Has been submitted to the EMEA for approval
About CKD and renal anaemia
-- Chronic kidney disease (CKD) leads to permanent loss of kidney function and results from damage to the kidney tissue.
-- Approximately one in ten people have CKD.4 In patients aged over 75 years, CKD is present in one out of two people.8 Renal failure kills more than 7,000 people in the UK every year.9
-- Anaemia is a common complication of CKD and there are approximately 100,000 people in the UK with a combination of CKD and renal anaemia.5
-- Renal anaemia is highly manageable with appropriate treatment. However, if left untreated, it can have a number of serious consequences ranging from effects on quality of life, cognitive function and libido, through to increased mortality.
-- Of vital importance is the strong association between anaemia and cardiovascular disease (CVD), the main cause of death amongst kidney dialysis patients.
Roche in anaemia
-- Roche has been committed to improving the lives of patients with anaemia for over 15 years through the provision of treatment and the support of innovative programmes, such as the Roche Foundation for Anaemia Research (RoFAR). By founding RoFAR, Roche aims to encourage new research that will take knowledge and understanding of anaemia and the use of anti-anaemia agents into new areas of medicine, such as neurology and cardiology.
-- Roche's contribution to the management of anaemia in both renal disease and cancer has been pioneered through the availability of NeoRecormon® (epoetin beta), which has been prescribed widely since it was first approved for use in 1991.
References
1. M Bernado et al. C.E.R.A. administered once monthly maintains stable Hb levels in patients with CKD on dialysis regardless of age and gender. Abstract Book - World Congress of Nephrology 2007, p212: Abstract M-FC-046.
2. Medscape Medical News. Care of ESRD patients could be better: New approaches warranted. February 21 2007
3. Collins AJ , Kasiske B , Herzog C , Chavers B , Foley R , Gilbertson D et al. Excerpts from the United States Renal Data System 2004 Annual Data Report: Atlas of End-Stage Renal Disease in the United States. American Journal of Kidney Diseases 2005; 45 (1 Supp 1): A5-7
4. International Federation of Kidney Foundations. World Kidney Day facts; 2007. www.worldkidneyday.org/pages/facts.php#faq2 [accessed April 2007]
5. National Collaborating Centre for Chronic Conditions at the Royal College of Physicians. Anaemia management in chronic kidney disease: national clinical guidelines for management in adults and children. March 2006
6. European Best Practice Guidelines
7. Lysaght MJ. Maintenance dialysis population dynamics: Current trends and long-term implications. Journal of the American Society of Nephrology 2002; 13 (1): S37-40
8. The National Kidney Federation website. Available at www.kidney.org.uk [accessed April 2007]
9. National Kidney Federation transplant facts. Available at www.kidney.org.uk/living-donor/factsht.html [accessed April 2007]
* Erythropoietin stimulating agent
http://www.roche.com
View drug information on Mircera.
Roche este nou SEC * Stabilises în mod eficient nivelul de hemoglobinã la pacienþii vârstnici pacienþi dializaþi - Roche's New ESA* Effectively Stabilises Haemoglobin Levels In Elderly Dialysis Patients - articole medicale engleza - startsanatate