Once-Monthly C.E.R.A. Keeps Haemoglobin Stable in High-Risk Kidney Disease Patients With Diabetes or Heart Disease

Basel, Switzerland (ots/PRNewswire) - An analysis of two
large-scale Phase III maintenance studies on C.E.R.A. has highlighted
that two high-risk patient populations - dialysis patients with
diabetes and/or coronary artery disease - consistently and safely
maintained their haemoglobin (Hb) levels at target levels after
direct conversion from more frequently administered epoetin to
once-monthly C.E.R.A., a continuous erythropoietin receptor
activator. This is a significant outcome as erratic Hb levels have a
serious negative impact in these high-risk patients. In addition,
being able to effectively control Hb levels with a convenient
once-monthly treatment is a further positive outcome.

"C.E.R.A. was effective in maintaining haemoglobin levels
irrespective of the presence or absence of diabetes or coronary
artery disease," said Dr Johannes Mann from the KfH Nierenzentrum in
Munich, German who presented the new data to delegates at the
congress. "This is important news for us since we often see dialysis
patients with multiple health conditions where it is critical not to
expose them to unnecessary or additional health risks associated with
fluctuating haemoglobin levels."

These award-winning data* were presented for the first time today
at the 44th European Renal Association-European Dialysis and
Transplant Association (ERA-EDTA) Congress in Barcelona. [1] The
investigators set out to examine Hb stability with C.E.R.A.
administered once monthly in patients with or without diabetes and
coronary artery disease (CAD) (history of angina, myocardial
infarction, coronary angioplasty or coronary artery bypass grafting),
which represents populations with a poor prognosis. Thirty-five per
cent of C.E.R.A. patients in the study had diabetes and 31% had CAD.

Diabetes is the leading cause of end stage renal disease in the
western world [2] [3] and cardiovascular disease is the major cause
of death in patients with diabetes[4]; both are frequently present in
CKD patients on dialysis either individually or together.

The Analysis

Adult patients (832) with stable baseline Hb were randomised in
two 52-week, Phase III multi-centre studies (MAXIMA and PROTOS) to
receive either IV or SC C.E.R.A. once monthly (415 patients) or to
continue with IV or SC epoetin (417 patients) administered once to
three times a week. The dose was adjusted no more frequently than
once every four weeks to maintain Hb within +/- 1 g/dL of their
original baseline value and within a range of 10 - 13.5 g/dL. The
change in Hb was investigated in the presence and absence of CAD or
diabetes.

Results

- Mean baseline haemoglobin levels in the C.E.R.A. group with and
without diabetes were 11.8 and 11.7 g/dL and with and without
coronary artery disease were 11.7 and 11.8 g/dL.

- During the evaluation period, stable Hb levels were maintained
irrespective of the presence or absence of CAD or diabetes.

- C.E.R.A. had a similar adverse event profile in patients with
and without diabetes or coronary artery disease; adverse events were
typical of the patient populations.

About C.E.R.A.

C.E.R.A., is a continuous erythropoietin receptor activator that
shows a different activity at the receptor level characterized by a
slower association to and faster dissociation from the receptor, a
reduced specific activity in vitro with an increased activity in
vivo, as well as an increased half-life, in contrast to
erythropoietin. C.E.R.A. is the only drug to have compared itself in
its registration program to three ESAs: epoetin alfa, beta and
darbepoetin alfa. C.E.R.A. is not marketed yet, but in May it
received an approvable letter from the US FDA and a positive opinion
from the European Committee for Medicinal Products for Human Use
(CHMP) recommending a marketing authorisation be granted in the EU.

About Roche

For more information please visit www.roche.com

Additional information about renal anaemia is available on the
Internet at www.AnaemiaWorld.com.

*This abstract, which was granted an oral presentation, was one of
three C.E.R.A. abstracts that received the honour of being among the
top eight best abstracts received by the congress this year.

References

---------------------------------

[1] Johannes Mann et al. C.E.R.A. provides stable haemoglobin (Hb)
levels in CKD patients on dialysis with and without coronary artery
disease (CAD) or diabetes mellitus (DM) when administered once
monthly .44th ERA-EDTA Barcelona 2007

[2] National Kidney Foundation website: Diabetes and Kidney
Disease, www.kidney.org

[3] Stevens PE, et al Anaemia in patients with diabetes:
unrecognised, undetected and untreated? Cur Med Res Opin 2003; 19 (5)
395-401.

[4] Levin A. et al. Cardiovascular disease and the kidney;
tracking a killer in chronic kidney disease. Postgrad Medicine 2002;
111: 453-60.

ots Originaltext: Roche Pharmaceuticals
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