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 (KDOQITM)
targets with Mimpara® (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 <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 (<33.0
pmol/L or 300 pg/ml), an indication of SHPT.
About Mimpara
Mimpara (also known as Sensipar® 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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