PRAGUE, June 28, 2011 /PRNewswire/ --
The 48th ERA-EDTA congress was the setting for a wide range of new clinical data. The "Late-Breaking Clinical Trials" were met with particular interest, one of them being the IMPACT SHPT study (Evaluation of the Effectiveness of Paricalcitol Versus Cinacalcet With Low-Dose Vitamin D). In the oral presentation on 25 June the principal investigator of this study, Prof. Markus Ketteler (Coburg, Germany), summarized the final data, whereas the abstract had presented the data of the interim analysis.
The international randomised phase IV open-label multi-centre study investigated 272 HD patients over a period of 28 weeks. The study was divided into Oral and IV Stratum. Patients received either paricalcitol (initial dose of 0.07 ug/kg in IV Stratum and PTH/80 in Oral Stratum) and additive cinacalcet for hypercalcaemia or cinacalcet (30 mg initial dose) plus low-dose vitamin D.
In the IV stratum, paricalcitol was superior to cinacalcet in achieving primary efficacy, a mean iPTH value between 150-300 pg/mL during evaluation period (paricalcitol = 57.7% and cinacalcet = 32.7%; p =0.016). In the oral stratum, superiority of paricalcitol over cinacalcet was not demonstrated (paricalcitol = 54.4% and cinacalcet = 43.4%). Overall, paricalcitol proved to be superior to cinacalcet in achieving primary efficacy (paricalcitol = 56.0% and cinacalcet = 38.2%, p = 0.010) using the Cochran-Mantel-Haenszel (CMH) test, which adjusted for strata.
Concerning side effects: hypocalcaemia developed in almost half of the subjects treated with cinacalcet (46.9% in the IV stratum and 54.7% in the oral stratum). Hypercalcaemia in paricalcitol-treated subjects was not significantly different from that in cinacalcet-treated subjects (7.7% in the IV stratum and none in the oral stratum).
Total SHPT medication costs were 40% lower in the paricalcitol arm compared with the cinacalcet arm. However, this analysis must be regarded as preliminary, since it was currently restricted to the study medication and did not take potential changes in concomitant medication (e.g. phosphate binders) into account.
As Prof. Ketteler emphasized, in this study paricalcitol proved to be efficient in lowering parathomone, low on side effects and with potential advantages concerning cost-effectiveness.
Press Office ERA-EDTA 2011
Dr. Bettina Albers
albers@albersconcept.de
+49-3643-776423
SOURCE European Renal Association European Dialysis and Transplant Association (RDA-EDTA)
