This article is more than 5 years old. Information may no longer be current.
Researchers assess 48-hour effects of cinacalcet in patients with secondary hyperparathyroidism
Click Here to Manage Email Alerts
The association between patients on hemodialysis with elevated parathyroid hormone, serum calcium, phosphorus levels, and the development of vascular calcifications has been established. However, in this patient population with secondary hyperparathyroidism controlled by cinacalcet (Sensipar, Amgen), researchers have found a transient reduction in parathyroid hormone and phosphorus, and an increase in calcitonin following each dose, further suggesting that the discontinuation of cinacalcet induces a significant increase of parathyroid hormone.
Researchers from the Hospital Perpetuo Socorro in Alicante, Spain, conducted a phase 4, open-label, single arm, single dose, clinical trial. Ten patients on cinacalcet for 6 months or longer with intact parathyroid hormone (PTH) levels of 100 pg/mL to 400 pg/mL were administered 30 mg (n=6), 60 mg (n=3) or 90 mg (n=1) of the drug.
According to data, patients displayed a significant reduction in intact PTH between 1 and 6 hours, and values returned to baseline at 24 hours (maximum mean percentage change from baseline: –50%; 95% CI, –34% to –66% at 3 hours). Researchers also observed a transient increase in calcitonin and a decrease in phosphorus, with no changes to calcium levels, they wrote.
Additionally, researchers reported a significant increase in intact PTH (51%; 95% CI, 26-76) and phosphorus at 48 hours. They determined that changes to PTH were similar with the three determination methods (intact PTH, Scantibodies Laboratory; iPTH, Roche Diagnostics; PTH 1-84, Scantibodies Laboratory).
These findings suggest that blood samples taken at 12 and 24 hours after the last dose of cinacalcet provide reliable information on the overall degree of PTH control over the 24-hour dosing period. Furthermore, the assay used to measure PTH does not influence relative changes induced by cinacalcet, the researchers wrote.
Disclosure: The researchers report no relevant financial disclosures.
Click Here to Manage Email Alerts