[Long-term clinical effect of maxacalcitol on hemodialysis patients with secondary hyperparathyroidism]

A trial on the long-term administration of 22-oxacalcitriol (maxacalcitol, OCT) was conducted among 124 patients with chronic renal failure on maintenance hemodialysis (HD) complicated with secondary hyperparathyroidism (2 degrees HPT ). In the trial, OCT was administered 3 times weekly for 26 weeks subsequent to a 26-week pre-trial. As a result, intact-parathyroid hormone (PTH) levels fell significantly after the start of administration and were well controlled for one year. The levels of markers of bone metabolism such as bone alkaline phosphatase were decreased significantly compared with those at the start of administration, suggesting a correction of high-turnover bone disease. Serum calcium (Ca) levels rose significantly following OCT administration, but were successfully maintained within a physiological range. Hypercalcemia, in 33.1% of patients, was found to resolve or ameliorate immediately after the withdrawal or dose reduction of OCT. The final doses ranged from 2.5 mg to 20 mg/HD, and the optimal dose varied among patients depending on the intact-PTH and serum Ca levels. These results clearly suggest that OCT is a highly effective drug for the treatment of 2 degrees HPT, and is an overall safe drug if the dosage is adjusted for serum Ca and intact-PTH levels.