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

An interim analysis of the EXTEND study1, conducted among 1,957 pre-dialysis patients in Europe, showed that subcutaneous darbepoetin alfa, 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. darbepoetin alfa Q2W or QM also brought ESA-naive patients to target Hb levels within three months.

 Analyses from the ALTERNATE study2,3 showed that the majority of haemodialysis (n=2,849) and peritoneal dialysis (n=428) patients successfully converted to and maintained Q2W darbepoetin alfa 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 darbepoetin alfa 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.

Speaking at WCN, Professor Bernard Canaud, HÙpital Lapeyronie, Montpellier, France commented: “Data from two large observational studies – EXTEND1 and ALTERNATE2,3 – 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. An ESA that offers flexible dosing intervals, such as darbepoetin alfa 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 darbepoetin alfa 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 cinacalcet to achieve therapeutic targets in SHPT4

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

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.

The new data presented at WCN from the ECHO European observational study, established to characterise practice patterns with cinacalcet, show important differences among countries regarding PTH levels at cinacalcet initiation. Although the study shows that PTH, Ca and P levels were reduced consistently across all countries after initiation of cinacalcet, a higher proportion of patients achieved the K/DOQI target range for PTH at month 12 in countries where cinacalcet 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 cinacalcet 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.