New Data at ERA-EDTA Show Mimpara® (Cinacalcet) Improves Management of Secondary Hyperparathyroidism in Daily Clinical Practice

STOCKHOLM, Sweden--(BUSINESS WIRE)--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^® (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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