Sensipar (Amgen) fails endpoint in EVOLVE trial

The Phase III EVOLVE" (EValuation Of Cinacalcet HCl Therapy to Lower CardioVascular Events) trial results were announced by Amgen, which trial evaluated Sensipar/Mimpara (cinacalcet) for the reduction of the risk of mortality and cardiovascular (CV) events among 3,883 patients with secondary hyperparathyroidism (HPT) and chronic kidney disease (CKD) receiving dialysis. The primary endpoint of the study 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. Although patients in the Sensipar/Mimpara arm experienced numerically fewer composite primary events, the results were not statistically significant, and the trial did not meet its primary endpoint in the intent-to-treat analysis.