Amgen Inc. (AMGN) announced top-line results of the Phase 3 EVOLVE trial, evaluating Sensipar/Mimpara for the reduction of the risk of mortality and cardiovascular or CV events among 3,883 patients with secondary hyperparathyroidism and chronic kidney disease receiving dialysis.
The trial's primary endpoint was time to the composite event comprising all-cause mortality or first non-fatal cardiovascular event, including myocardial infarction, hospitalization for unstable angina, heart failure or peripheral vascular event. Though patients in the Sensipar/Mimpara arm experienced numerically fewer composite primary events, the results were not statistically significant, and the study failed to meet its primary endpoint in the intent-to-treat analysis.
"Amgen embarked on the EVOLVE trial to understand whether treating secondary HPT with Sensipar/Mimpara could positively impact the high rates of mortality and cardiovascular events among patients with CKD receiving dialysis," said Sean Harper, M.D., executive vice president of Research and Development at Amgen.
The most frequently reported adverse events in the Sensipar/Mimpara arm of the trial were consistent with the known safety profile of this therapy and included nausea, vomiting and hypocalcemia.
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