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EVOLVE: Difference between revisions
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==Major Points==<!-- remove when cleared by an editor --> | ==Major Points==<!-- remove when cleared by an editor --> | ||
Secondary hyperparathyroidism in chronic kidney disease patients has been | Secondary hyperparathyroidism in chronic kidney disease patients has been theorized to be a non-traditional risk factor for cardiovascular disease. High parathryoid hormone (PTH) may lead to increased vascular calcification, arterial stiffness, and left ventricular hypertrophy. Cinacalcet is a calcimimetic agent that primarily acts as an allosteric modulator of the calcium sensing receptor (CaSR) on parathyroid tissue, reducing serum PTH, calcium, and phosphorus levels. | ||
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 Time to Death or First Cardiovascular event showed no significant difference between groups. However, a prespecified analysis of study results accounting for high dropout rates (lag-censoring analysis) revealed a 15% relative hazard reduction in the composite primary endpoint and a 7% relative hazard reduction in mortality. Another analysis adjusting for differences in baseline characteristics similarly found an 11% relative hazard reduction in the composite primary endpoint and an 11% relative hazard reduction in mortality. Controversy exists on how these adjusted analyses should be interpreted. The KDIGO recommendations on the use of cinacalcet did not change following the publication of this trial. | |||
Secondary outcomes demonstrated a reduced need for parathyroidectomy in patients treated with cinacalcet. Despite the reduction in PTH levels, the risk of fracture remained similar in both groups. | |||
== Headline text == | == Headline text == | ||