The study of 3,883 patients, with secondary hyperparathyroidism (HPT) and chronic kidney disease (CKD) receiving dialysis, evaluated Sensipar/Mimpara (cinacalcet) for the reduction of the risk of mortality and cardiovascular events.
Amgen research and development executive vice president Sean Harper said 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.
"EVOLVE will provide the nephrology community with important information," Harper added.
The primary endpoint of the study was the 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.
Even though numerically fewer composite primary events were experienced by the patients in the Sensipar/Mimpara arm, the results were not statistically significant, and the trial did not meet its primary endpoint in the intent-to-treat analysis.