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Datum nieuwsfeit: 12-05-2008
New Data at ERA-EDTA Show Mimpara Improves Management of Secondary Hyperparathyroidism in Daily Clinical Practice
( BW)(CA-AMGEN) New Data at ERA-EDTA Show Mimpara(R) (Cinacalcet)
Improves Management of Secondary Hyperparathyroidism in Daily Clinical
Practice
Business Editors/Health/Medical Writers
STOCKHOLM, Sweden--(BUSINESS WIRE)--May 12, 2008--
KDOQI(TM) Target Achievement Improved for All Four Disease
Parameters Following Initiation of Treatment with Mimpara
Amgen (Europe) GmbH today announced results from the Evaluation of
the Clinical Use of Mimpara in Haemodialysis and Peritoneal Dialysis
Patients, an Observational Study (ECHO) at the European Renal
Association - European Dialysis and Transplant Association (ERA-EDTA)
congress. Data show that a higher percentage of dialysis patients with
secondary hyperparathyroidism (SHPT) achieved and maintained National
Kidney Foundation Kidney Disease Outcomes Quality Initiative
(KDOQI(TM)) targets with Mimpara(R) (cinacalcet), compared to their
previous treatment (vitamin D sterols and phosphate binders). In
addition, data also show that Mimpara effectively controls SHPT
regardless of whether patients were receiving concomitant vitamin D.
"The achievement and maintenance of KDOQI targets is desirable for
achieving optimal SHPT patient management. For the first time, these
new final data demonstrate cinacalcet's effectiveness in daily
clinical practice, confirming that improvements seen with cinacalcet
in randomised clinical trials can be reproduced in the clinic," said
Doctor Neil Ashman, consultant nephrologist and honorary senior
lecturer, Renal Unit, Barts and the London NHS Trust, London, UK.
Results from this pan-European observational study demonstrate
that a higher percentage of SHPT patients (n=1865) achieved and
maintained KDOQI targets for all four parameters - parathyroid hormone
(iPTH), phosphorus (P), calcium (Ca) and calcium phosphorus product
(Ca x P) - for up to 12 months following initiation of Mimpara,
compared to their previous treatment (standard care: vitamin D sterols
and phosphate binders). KDOQI targets include iPTH 150-300 pg/ml,
3.5-5.5 mg/dl, Ca 8.4-9.5 mg/dl, Ca x P less than 55 mg2/dl2.
Mimpara improved attainment of targets in a patient population
with severe SHPT (median iPTH was 721 pg/mL and 54% of patients had
uncontrolled Ca x P at baseline). In addition, only a small proportion
of patients on traditional therapy were able to sustain KDOQI targets
in the six months prior to the introduction of cinacalcet despite the
extensive use of vitamin D and phosphate binders. These results are
important because the role of vitamin D in controlling SHPT in
dialysis patients may be limited by the development of hypercalcemia
and hyperphosphatemia.
Adverse events related to treatment were reported in 11.3% of
patients. The most common adverse events were nausea (4.6%) and
vomiting (3.1%). Six patients (0.3%) experienced serious adverse
events and there were no treatment-related deaths. 75.5% of patients
remained on Mimpara at end of study; the main reason for
discontinuation was renal transplantation (5.2% of patients).
About the ECHO Study
ECHO is a pan-European, multicenter, observational study that
explored Mimpara use in daily clinical practice. The study enrolled
1865 SHPT and dialysis patients between July 2005 and October 2006
from 187 sites in 12 countries. Patients on dialysis were enrolled six
months before and up to 12 months after initiating treatment with
cinacalcet.
About SHPT
Secondary hyperparathyroidism (SHPT) is a metabolic disorder that
develops in chronic kidney disease (CKD) patients on dialysis and
results in increased secretion of parathyroid hormone (PTH), which may
lead to bone disease, bone pain and fractures, cardiovascular and soft
tissue calcification and parathyroid hyperplasia.
Patients develop SHPT as their kidneys fail because their ability
to excrete phosphorus and produce active vitamin D diminishes, leading
to a fall in blood calcium levels. Additionally, a low level of
calcium results in stimulating the parathyroid gland to secrete more
PTH in an attempt to normalise blood levels of calcium. Over time,
continuous PTH secretion leads to excessive growth of the parathyroid
gland, high levels of PTH, calcium and phosphorus, and HPT
complications including bone disease and soft tissue and vascular
calcification, which increases the risk for cardiovascular events.
The majority of an estimated 324,000 CKD patients on dialysis in
Europe suffers from some degree of SHPT. According to the Dialysis
Outcomes and Practice Patterns Study (DOPPS) 26 percent of CKD
patients on dialysis throughout the world had PTH levels above the
KDOQI guidelines (less than 33.0 pmol/L or 300 pg/ml), an indication
of SHPT.
About Mimpara
Mimpara (also known as Sensipar(R) in the United States,
Australia, New Zealand and Canada) is a calcimimetic agent that is
approved for the treatment of secondary hyperparathyroidism (SHPT) in
patients with chronic kidney disease receiving dialysis.
Calcimimetics amplify the action of calcium on the calcium-sensing
receptors on the parathyroid gland, thereby decreasing the secretion
of PTH. Mimpara is the first and only calcimimetic agent approved for
use in dialysis patients to specifically bind to and directly modulate
the calcium-sensing receptor on the surface of the chief cell of the
parathyroid gland while simultaneously lowering blood calcium and
phosphorus levels. In dialysis patients, Mimpara significantly reduces
PTH levels while simultaneously lowering blood calcium and phosphorus
levels. Mimpara binds to the parathyroid gland's calcium-sensing
receptors, making them more sensitive to calcium, which causes the
gland to reduce its release of PTH.
The threshold for seizures may be lowered by reductions in calcium
levels and, infrequently, seizures have been reported with use of
Mimpara. The most commonly reported side effects are nausea and
vomiting. In post-marketing safety surveillance, isolated,
idiosyncratic cases of hypotension and/or worsening heart failure have
been reported in patients with impaired cardiac function, in which a
causal relationship to Mimpara could not be completely excluded and
may be mediated by reductions in serum calcium levels.
About Amgen
Amgen discovers, develops, manufactures and delivers innovative
human therapeutics. A biotechnology pioneer since 1980, Amgen was one
of the first companies to realize the new science's promise by
bringing safe and effective medicines from lab, to manufacturing
plant, to patient. Amgen therapeutics have changed the practice of
medicine, helping millions of people around the world in the fight
against cancer, kidney disease, rheumatoid arthritis, and other
serious illnesses. With a deep and broad pipeline of potential new
medicines, Amgen remains committed to advancing science to
dramatically improve people's lives. To learn more about our
pioneering science and our vital medicines, visit www.amgen.com.
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