THOUSAND OAKS, Calif.
Nov. 3, 2012
/PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced results of the Phase 3 EVOLVE™ (EValuation Of Cinacalcet HCl Therapy to Lower CardioVascular Events) trial, which evaluated treatment with Sensipar
(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 CV event, including myocardial infarction, hospitalization for unstable angina, heart failure or peripheral vascular event.
Although patients in the Sensipar/Mimpara arm experienced a seven percent reduction in the primary endpoint (Hazard Ratio 0.93, 95 percent CI 0.85 to 1.02,
=0.112), the results were not statistically significant, and the trial did not meet its primary endpoint in the intent-to-treat analysis. These data were published today in the
New England Journal of Medicine
and simultaneously presented at the American Society of Nephrology's Kidney Week (Abstract # 6450).
Baseline characteristics between the Sensipar/Mimpara and placebo groups were generally well-balanced with the notable exception of age – an important predictor of death and CV events. Patients in the Sensipar/Mimpara group were one-year older than those in the placebo group (median age 55 and 54 years, respectively). A pre-specified analysis adjusting for baseline imbalances showed that treatment with Sensipar/Mimpara resulted in a 12 percent reduction in the primary endpoint (Hazard Ratio 0.88, 95 percent CI 0.79 to 0.97).
Discontinuation of investigational product was common in both arms and more frequent in the placebo group (66.7 percent Sensipar/Mimpara versus 70.5 percent placebo). Reasons for discontinuation included kidney transplant, parathyroidectomy, adverse events and patient request. A pre-specified analysis, which excluded data from patients that was collected beyond six months after stopping investigational product, showed a 15 percent reduction in the primary endpoint (Hazard Ratio 0.85, 95 percent CI 0.76 to 0.95).