The above described pre-specified analyses, however, cannot be interpreted as definitive.
Cardiovascular disease is common among patients with CKD, including those treated with dialysis, among whom death due to cardiovascular disease is approximately 10 to 100-fold higher than in the general population. Secondary HPT, a disorder which is characterized by abnormal parathyroid hormone, calcium and phosphorus levels, has emerged as one of several complications of CKD thought to contribute to high rates of CV events and death in the patient population receiving dialysis.
"The EVOLVE trial is one of the largest outcomes studies ever conducted in patients on dialysis, who are among our society's most chronically ill. Cardiovascular disease is unacceptably high among these patients, accounting for nearly half of all deaths. While EVOLVE did not meet its primary endpoint, the study provides important information related to the management of these patients," said
, M.D., senior vice president of Global Development and corporate chief medical officer 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. As reported in the primary manuscript, rates of serious adverse events were similar in both groups. There were 115 and 90 neoplastic events (25 and 23 fatal) in the Sensipar/Mimpara and placebo groups, respectively.
Sensipar/Mimpara is an oral calcimimetic agent approved for the treatment of secondary HPT in patients with CKD receiving dialysis.
EVOLVE Trial Design
EVOLVE was an international, randomized, double-blind, placebo-controlled Phase 3 study of 3,883 patients with secondary HPT and CKD receiving dialysis. The trial, the largest of its kind in patients with CKD receiving dialysis, was designed to determine if treatment with Sensipar/Mimpara, compared to placebo, decreases the risk of all-cause mortality and CV morbidity. The primary composite endpoint of the study was time to death or first non-fatal cardiovascular event (myocardial infarction, hospitalization for unstable angina, heart failure or peripheral vascular event). Secondary endpoints included time to individual components of the primary composite endpoint, cardiovascular mortality, stroke, bone fracture and parathyroidectomy.