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ERA-EDTA Congress 2011: Late Breaking Clinical Trials II

PRAGUE, June 25, 2011 /PRNewswire/ --


The SHARP-study has shown that lowering LDL cholesterol with ezetimibe/simvastatinleads to a significant reduction in major atherosclerotic events among CKD-patients. Whether it also has a favourable effect on renal disease progression was another of the issues addressed by the SHARP study [abstract no. 2509]. In the ezetimibe/simvastatin group, fewer patients reached the end point "end stage renal disease", but the difference was not significant [p = 0.41].

No improvement in cardiovascular outcome due to optimised treatment quality

Cardiovascular comorbidity in CKD patients is dramatically high. The MASTERPLAN study [abstract no. 2511] aimed to evaluate whether strict implementation of all the current treatment guidelines leads to a better cardiovascular outcome in CKD patients. The primary endpoint was a composite of myocardial infarction, stroke and cardiovascular death. Despite intensified therapy and better lab values it was not possible to significantly improve cardiovascular outcome in the intervention group.

Benefits of tacrolimus therapy with prolonged release in de novo kidney transplant patients

Various immunosuppressive drugs are available, one of these being tacrolimus (Tac). There are tacrolimus products that release their active substance immediately (Tac BID) and others that release it in a prolonged manner (Tac QD). The open-label OSAKA study [abstract no. 2505] compared these two drug forms in various doses. Tac QD led to the achievement of target blood level in more patients within the first few days after transplantation than Tac BID in an identical dose.

Which SHPT therapy should be used?

In the randomised phase IV IMPACT study [abstract no. 2519] 272 hemodialyis patients with seconday hyperparathyreoidism received either paricalcitol or cinacalcet plus low-dose vitamin D. This interim analysis showed that in the paricalcitol group 78% of patients achieved an iPTH reduction of ≥30% and 65% achieved a reduction of ≥50% whilst in the cinacalcet group the figures were 50% and 36% of patients. Concerning side effects, 4 of 69 patients developed hypercalcaemia in the paricalcitol arm, while 27 of 59 patients developed hypocalcemia in the cinacalcet arm.

For further information

Bettina Albers

SOURCE European Renal Association European Dialysis and Transplant Association (RDA-EDT
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