Cinacalcet fails to improve cardiovascular outcomes in dialysis

The risk of cardiovascular death in patients with chronic kidney disease is increased by a factor of ten in comparison with the general population. While a host of factors including chronic inflammation, increased oxidative stress and endothelial dysfunction contribute to this risk, disorders of mineral metabolism, including secondary hyperparathyroidism, are thought to contribute by promoting extraskeletal (including vascular) calcification. Cinacalcet is a calcimimetic agent that reduces levels of parathormone, calcium and phosphorous and in this large randomised controlled trial was assessed to reduce the risk of death or nonfatal cardiovascular events in patients on haemodialysis.

A total of 3883 patients with moderate-to-severe secondary hyperparathyroidism who were undergoing haemodialysis were randomised to receive either cinacalcet or placebo along with conventional therapy, including phosphate binders, vitamin D sterols, or both. Patients were followed for up to 64 months with the primary end point a composite of time until death, myocardial infarction (MI), hospitalisation for unstable angina, heart failure (HF), or a peripheral vascular event. In an intention to treat analysis there was no benefit demonstrated with cinacalcet with the primary composite end point reached in 938 of 1948 patients (48.2%) in the cinacalcet group and 952 of 1935 patients (49.2%) in the placebo …