Natrium-Zirkonium-Cyclosilikat (1) – Lokelma®

• Clinical trials
  • Nevertheless, the pharmaceutical manufacturer has submitted the randomised, controlled trials DIALIZE, ENERGIZE, ZS-002, ZS-003 and D9482C00002 (ZS-002 Japan).
  • In all the studies submitted, sodium zirconium cyclosilicate was compared with placebo.

Adults with hyperkalaemia

• The additional benefit is not proven.
• No relevant studies comparing sodium zirconium cyclosilicate with the appropriate comparator therapy were identified for the assessment of its additional benefit in the treatment of adults with hyperkalaemia.
• Overall, it can be concluded that individualised treatment was not guaranteed in the comparator arm of the submitted studies, particularly due to the fact that adjustments to drug therapy were either not permitted or only permitted to a limited extent; consequently, the appropriate comparator therapy was not implemented.
• Furthermore, the study duration of the studies submitted by the pharmaceutical manufacturer – which, for example, was a maximum of 10 weeks in the DIALIZE study, 8 days in the ENERGIZE study and 3 weeks in the ZS-003 study, is insufficient for assessing the additional benefit in the therapeutic indication of hyperkalaemia.
• Furthermore, the pharmaceutical manufacturer’s categorisation into different treatment scenarios based on the dosage recommendations in the SmPC (correction phase, maintenance phase and the need for dialysis) is viewed critically.
• In summary, the studies submitted by the pharmaceutical manufacturer are not suitable for evaluating a comparison of sodium zirconium cyclosilicate against the appropriate comparator therapy.
• An additional benefit is therefore not proven.
• Overall assessment
  • No relevant studies comparing the drug with the appropriate comparator therapy were identified. Furthermore, in the studies submitted by the pharmaceutical manufacturer comparing sodium zirconium cyclosilicate with placebo, the appropriate comparator therapy was not implemented, as patient-specific treatment, for example through adjustments to drug therapy, was largely not possible or led to the discontinuation of the study medication. Furthermore, the study duration was too short to assess any additional benefit. An additional benefit is therefore not proven.

Courtesy translation only, please refer to the German original.