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Published in 2012, the '''EV'''aluation '''O'''f Cinacalcet HCl Therapy to '''L'''ower Cardio'''v'''ascular '''E'''vents (EVOLVE) trial was conducted to determine if administration of cinacalcet in dialysis patients reduced cardiovascular death and mortality. This multi-centre, multi-national, blinded randomized control trial enrolled 3883 patients randomized to either cinacalcet or placebo. Drug doses were elevated throughout the trial to meet PTH and calcium targets. Both groups received baseline therapy of phosphate binders, vitamin D, calcium supplements, and dialysis at the discretion of the treating provider. | Published in 2012, the '''EV'''aluation '''O'''f Cinacalcet HCl Therapy to '''L'''ower Cardio'''v'''ascular '''E'''vents (EVOLVE) trial was conducted to determine if administration of cinacalcet in dialysis patients reduced cardiovascular death and mortality. This multi-centre, multi-national, blinded randomized control trial enrolled 3883 patients randomized to either cinacalcet or placebo. Drug doses were elevated throughout the trial to meet PTH and calcium targets. Both groups received baseline therapy of phosphate binders, vitamin D, calcium supplements, and dialysis at the discretion of the treating provider. | ||
The primary endpoint of either time to death or first cardiovascular event showed | The primary endpoint of either time to death or first cardiovascular event showed a non-significant difference of 7% between groups. However, a prespecified analysis of study results accounting for high dropout rates (lag-censoring analysis) revealed a 12% relative hazard reduction in the composite primary endpoint and a 14% relative hazard reduction in mortality. Another analysis adjusting for differences in baseline characteristics similarly found an 15% relative hazard reduction in the composite primary endpoint and an 17% relative hazard reduction in mortality. Controversy exists on how these adjusted analyses should be interpreted, and some consider the outcomes of this trial to be inconclusive. The KDIGO recommendations on the use of cinacalcet did not change following the publication of this trial<ref name=":1" />. | ||
The study was significantly underpowered secondary to high dropout rates secondary to side effects in both groups, as well as high cross-over rates in the placebo group to commercial cinacalcet<ref name=":2" />. | The study was significantly underpowered secondary to high dropout rates secondary to side effects in both groups, as well as high cross-over rates in the placebo group to commercial cinacalcet<ref name=":2" />. | ||