Basel, Switzerland (ots/PRNewswire) -
- Findings Illustrate Role of Innovative New Treatment in
Population Most Affected by Chronic Kidney Disease
A new Roche Phase III analysis shows once-monthly MIRCERA, a
continuous erythropoietin receptor activator, effectively treats
renal anaemia in one of the fastest growing groups of patients with
chronic kidney disease (CKD) -- elderly patients who are on dialysis.
In this analysis, MIRCERA treatment kept Hb levels stable, deviating
less than 0.5 g/dL from start of the trial in patients over age 65
with a simplified dosing schedule. The data were presented today at
the World Congress of Nephrology (WCN) in Rio de Janeiro.
"These results show that MIRCERA safely and effectively treated a
group of kidney disease patients who represent the 'face' of dialysis
and also have the poorest prognosis," said Marializa Bernardo M.D.,
Southwest Nephrology Associates, Houston Texas, who presented the
data. "Elderly dialysis patients are fragile because they suffer from
a range of coexisting diseases along renal anaemia that worsen their
health, impact their quality of life and increase their risk of
hospitalization and death. This analysis shows that those elderly
patients on dialysis who were directly converted from treatment given
up to three times a week to MIRCERA twice monthly or once monthly
maintained stable haemoglobin levels."
The prevalence of CKD patients on dialysis is projected to grow 7
per cent per year and it is estimated that by 2010, there will be
over 2 million people worldwide on dialysis.(i)
These results, based on a pooled analysis from two large MIRCERA
Phase III maintenance studies, evaluated patients age 18 and older
that are representative of the real world dialysis population. The
mean age of patients included in the analysis was 60 years of age
(however more than 40 per cent of patients were over age 65) and
patients had already been on dialysis from 33 to 40 months. The study
also found a higher transfusion requirement in elderly patients. A
significant number of patients entering the study suffered from
diabetes (more than 35 per cent) and arterial hypertension (more than
90 per cent) -- two of the main causes of CKD and among the most
common co-morbid conditions in CKD patients.
The results showed that intravenous (IV) and subcutaneous (SC)
MIRCERA maintained stable Hb levels in dialysis patients over and
under 65 years of age who were successfully switched from the
frequently administered agents, epoetin alfa and beta. The study
investigators also noted:
- Minimal changes from baseline to evaluation in mean Hb levels in
patients less than or equal to 65 and >65 years (-0.18 vs -0.34
g/dL), meaning that the elderly can be treated with confidence.
- Minimal mean Hb changes from baseline to evaluation in male and
female patients treated with MIRCERA (-0.21 vs -0.30 g/dL).
MIRCERA treatment was well tolerated, with a safety profile
characteristic of the patient population.
"With more elderly people needing dialysis treatment, doctors will
need effective medications that can improve the way we manage renal
anaemia. These findings underscore the value of MIRCERA in meeting a
goal of anaemia management, namely haemoglobin stability," said Dr.
Elias David Neto, Centro de Nefrologia e Transplante Renal,
University of São Paulo, São Paulo, Brazil.
Bearing the Burden of Chronic Kidney Disease: The Prevalence of
Dialysis in an Aging Population
Dialysis is the only treatment option for end stage renal disease
patients who are either waiting for or not a candidate for a renal
transplant. The number of people over the age of 65 with end stage
renal disease is on the rise because of an aging population and the
diabetes epidemic.(ii),(iii) In fact, more than 50 percent of the
people on dialysis are over 60 years of age.(iv) Further, it is known
that at the time patients reach ESRD, more than 50 per cent of
patients have congestive heart failure, heart disease, and diabetes,
and more than 80 per cent have hypertension.(v)
These patients bear a significant disease burden that impacts
their long-term prognosis. The United States Renal Data System
indicates that elderly dialysis patients are:
- Expected to live ten years less than their healthy counterparts
of the same age
- More likely to have heart disease than healthy patients
- More likely to have strokes than their healthy counterparts
- At increased risk for death from cardiovascular events
About the WCN Clinical Analysis
Today's analysis was based on data from two trials (MAXIMA and
PROTOS) which were part of the largest clinical development program
ever for the treatment of renal anaemia. In these two trials 1,245
dialysis patients were randomized to remain on their current epoetin
treatment administered up to three times or week or to be switched
(converted) directly to MIRCERA administered IV or SC once every two
weeks or once every four weeks.
Initial findings from the MIRCERA Phase III program, which
included four conversion/maintenance and two initiation/correction
studies, were presented at the European Renal Association-European
Dialysis and Transplant Association congress in June 2006 and at the
American Society of Nephrology's Renal Week in November 2006. The
maintenance study results showed that for the first time, patients
with CKD on dialysis treated with short-acting and frequently
administered epoetin anti-anaemia drugs can be switched successfully
and directly to a once-monthly treatment. In the correction studies,
the findings showed CKD patients on dialysis, as well as those not on
dialysis who need correction of renal anaemia, can be successfully
treated with MIRCERA on a simple twice-monthly dosing schedule.
MIRCERA, a continuous erythropoietin receptor activator, is the
first of a new class of long-acting chemically synthesized
erythropoiesis-stimulating agents (ESAs) having reached regulatory
review that could represent a significant advance in renal anaemia
management. It is in development for the treatment of renal anaemia
in chronic kidney disease (CKD) patients on dialysis or not on
dialysis. The largest clinical program ever undertaken in renal
anaemia has shown that MIRCERA provides predictable and stable
haemoglobin management for all CKD patients with up to once-monthly
dosing. This innovative agent is currently being reviewed by health
authorities in the EU, USA, Switzerland, Canada and Australia.
Notes to Editors:
1. Renal anaemia is caused when the kidneys fail to stimulate the
production of red blood cells, which transport the oxygen-carrying
protein, haemoglobin, throughout the body. Renal anaemia is present
in the early stages of CKD and becomes increasingly common and more
severe and more common as the disease progresses. In fact, as
patients reach end-stage renal disease, more than 90 per
cent(vi)(vii), (viii), of them will be affected by renal anaemia.
2. Current European (EBPG) and US (NKF- K/DOQI) guidelines
recommend doctors target specific ranges in treating renal anaemia.
For more information, visit www.roche.com.
(i) Lysaght MJ., Maintenance dialysis population dynamics: current
trends and long-term implications. Journal of the American Society of
Nephrology. 2002. 13: S37-S40.
(ii) Medscape Medical News "Care of ESRD Patients Could be Better:
New Approaches Warranted" February 21, 2007
(iii) Collins et al, Excerpts from the Unites States Renal Data
System 2004 Annual Data Report: Atlas of End-Stage Renal Disease in
the United States. American Journal of Kidney Diseases. Vol 45, No 1,
Suppl 1, January 2005
(iv) European Best Practice Guidelines
(v) United States Renal Data System, 2006
(vi) Obrador et al., Trends in anemia at initiation of dialysis in
the United States. Kidney International. 60:1875-1884, 2001
(vii) Hsu C.Y., Epidemiology of anemia associated with chronic
renal insufficiency. Current Opinion in Nephrology and Hypertension.
(viii) Hsu C.Y., et al Epidemiology of anemia associated with
chronic renal insufficiency among adults in the United States:
Results from the Third National Health and Nutrition Examination
Survey. Journal of the American Society of Nephrology. 2002;
ots Originaltext: Roche Pharmaceuticals
Im Internet recherchierbar: http://www.presseportal.ch
Further information: Sheila Gies, Roche, Phone: +1-973-687-0188;
Abenaa (Abby) Hayes, Weber Shandwick Worldwide, Phone: +212-445-8337