New Findings Provide Additional Insights into the Management of Anaemia and Secondary Hyperparathyroidism in Chronic Kid

MILAN, May 25 /PRNewswire/ --

Data presented from large-scale observational studies provide new insights into the day-to-day management of two major complications of CKD: anaemia and secondary hyperparathyroidism (SHPT).(1), (2), (3), (4)

    
    - CKD anaemia: Aranesp(R) (darbepoetin alfa) flexible dosing intervals
      help maintain haemoglobin (Hb) levels within the target range for
      dialysis and pre-dialysis patients, while offering the convenience of
      extended dosing(1), (2), (3)
    - SHPT: New European data show the importance of early initiation of
      Mimpara(R) (cinacalcet) to achieve therapeutic targets in SHPT(4)

A nephrology pioneer for more than 20 years, Amgen presented at the World Congress of Nephrology 2009 (WCN) additional results from observational studies with Aranesp and Mimpara demonstrating its commitment to nephrology research and innovation.

An interim analysis of the EXTEND study,(1) conducted among 1,957 pre-dialysis patients in Europe, showed that subcutaneous Aranesp, given either Q2W* or QM*, corrected and maintained target Hb levels in both ESA-prior (n=917) and ESA-naive (n=1040) patients. No dose increase was associated with switching to an extended dosing regimen and target Hb levels were maintained or improved. Aranesp Q2W or QM also brought ESA-naive patients to target Hb levels within three months.

Analyses from the ALTERNATE study(2), (3) showed that the majority of haemodialysis (n=2,849) and peritoneal dialysis (n=428) patients successfully converted to and maintained Q2W Aranesp dosing over 12 months. Before the switch, most patients received ESA dosing intervals ranging from TIW/BIW* to QW*.

Overall ESA dose was maintained after conversion to Aranesp Q2W, and extending the dosing interval did not change the proportion of patients maintained within the defined target Hb range.(2), (3) This was initially set at 11-13g/dL, but was revised in European countries to 10-12g/dL in line with new guidance issued during the course of the study.(5)

Speaking at WCN, Professor Bernard Canaud, Hopital Lapeyronie, Montpellier, France commented: "Data from two large observational studies - EXTEND(1) and ALTERNATE(2), (3) - show that the majority of CKD anaemia patients can switch to extended dosing regimens with darbepoetin alfa, offering further insights into its efficacy and safety."

Treating CKD anaemia is difficult due to the complexity involved with maintaining Hb targets in the presence of intercurrent events, such as inflammation, and patient comorbidities, including diabetes and cardiovascular disease. Evidence of the frequency of events that can interfere with erythropoiesis and induce Hb excursions can be found in a study carried out in France. The investigators found an average of 7.7 events per patient each month. Based on these observations, the investigators recommended close monitoring of clinical events and Hb levels, and adapting ESA treatment to specific patients' needs.(6) An ESA that offers flexible dosing intervals, such as Aranesp is considered by many nephrology experts to better address these underlying patient conditions and adapt to changing patient circumstances.

"We cannot currently predict which patients will need to switch back to more frequent dosing, either on a temporary or permanent basis," remarked Professor Canaud. "Best practice in ESA treatment offers a flexible dosing regimen - QW/Q2W/QM - to enable physicians to manage natural haemoglobin fluctuations in a timely and convenient manner."

The need for flexible dosing interval is clearly demonstrated in the ALTERNATE analysis of haemodialysis patients.(2) After conversion to the extended Q2W regimen, 23.5% (669 of 2,849) of patients were switched back to QW dosing at some point during the study. For many, this switch was temporary and at month twelve, 80% of patients were receiving Aranesp Q2W. In most cases, the switch was to manage either low or high Hb levels.(2)

New European data show the importance of early initiation of Mimpara (cinacalcet) to achieve therapeutic targets in SHPT(4)

The National Kidney Foundation (NKF) Kidney Disease Outcomes Quality Initiative (K/DOQI(TM)) provides evidence-based clinical practice guidelines that have transformed the care of patients with kidney disease.(7)

Data from the previously presented observational COSMOS study, established to survey bone mineral disturbances among haemodialysis patients across Europe, have shown the difficulty of meeting these targets in current clinical practice. The percentage of patients achieving K/DOQI targets was only 29.1% for parathyroid hormone (PTH) and only half of patients were achieving the targets for Calcium (Ca) and Phosphorus (P) - 50.5% and 51.5% respectively.(8)

The new data presented at WCN from the ECHO European observational study, established to characterise practice patterns with Mimpara, show important differences among countries regarding PTH levels at Mimpara initiation. Although the study shows that PTH, Ca and P levels were reduced consistently across all countries after initiation of Mimpara, a higher proportion of patients achieved the K/DOQI target range for PTH at month 12 in countries where Mimpara was initiated at lower baseline PTH levels (36% in Austria with a mean baseline PTH of 605 pg/mL as opposed to 14% in UK/Ireland with a mean baseline PTH of 954 pg/mL). The target achievement for Ca and P also increased 12 months after the initiation of Mimpara across all countries as compared to baseline, 51% versus 40% for Ca and 48% versus 39% for P.(4)

When not fully controlled, SHPT is a serious life-threatening condition and guidelines show that effective treatment should address all key biochemical parameters. The data from the ECHO study clearly show the efficacy of cinacalcet across all of these parameters, and provide evidence that more aggressive treatment by earlier intervention with cinacalcet provides more comprehensive control with more patients achieving these targets.(4)

Notes to Editors:

    
    * Key to ESA dosing schedules:
    TIW    Three times a week       BIW     Twice a week
    QW     Once a week              Q2W     Once every two weeks
    QM     Once a month

About the Studies:

EXTEND is a multicenter, international, observational, longitudinal, non-interventional study of non-selected adult patients with CKD not undergoing dialysis to assess the efficacy and safety of switching to an extended sub-cutaneous dosing regimen (Q2W/QM) of Aranesp(R). Approximately 300 centres and 3,500-4,000 patients in Europe and Australia are expected to participate.

ALTERNATE (A Long-term Non-interventional Trial to Evaluate the Effectiveness of Aranesp(R) in Dialysis Patients When Administered Once Every Two Weeks) is a non-interventional study among >6,000 patients greater than or equal to 18 years of age, with CKD and receiving dialysis treatment, who started treatment for renal anaemia with Aranesp(R) Q2W on or after August 1, 2004, with or without prior ESA treatment. Patients enrolled in the study from selected dialysis centers in participating countries were treated according to the usual clinical practice in the respective centre; clinical management was not altered for this non-interventional study.

COSMOS (Current management Of Secondary hyperparathyroidism - a Multicentre Observational Study) is a 3-year, multicentre, open-label, prospective study surveying bone mineral disturbances in haemodialysis patients. It includes data from 4,500 dialysis patients at 227 centres in 20 European countries.

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