Update on IMPACT Study Results

June 28, 2011

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

SOURCE European Renal Association European Dialysis and Transplant Association (RDA-EDTA)

Source: newswire

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