Nephrol Dial Transplant (2002) 17: 28-36
© 2002 European Renal Association-European Dialysis and Transplant Association
Long-term effect of 1,25-dihydroxy-22-oxavitamin D3 on secondary hyperparathyroidism in haemodialysis patients. One-year administration study
1 Center of Blood Purification Therapy, Wakayama Medical University, Wakayama, Japan, 2 Department of Internal Medicine, Shinrakuen Hospital, Niigata Social Services Organization, Social Welfare Department, Niigata, Japan, 3 Division of Blood Purification and Medicine, Kidney Center, Tokyo Women's Medical University, Tokyo, Japan, 4 Metabolism and Endocrinologic Medicine, Osaka City University Postgraduate School of Medicine, 5 Biostatistics for the Health and Nursing Sciences Section, Medical Research Department, University of Tokyo, Tokyo, Japan, 6 Foundation for Cancer Research Hospital, Tokyo, Japan, 7 Renal Division, Washington University School of Medicine, St Louis, Missouri, USA and 8 Tokai University School of Medicine, Isehara, Japan
Abstract
A trial on the long-term administration of 1,25-dihydroxy-22-oxavitamin D3 (22-oxacalcitoriol, OCT) was conducted among 124 patients with chronic renal failure on maintenance haemodialysis (HD) complicated with secondary hyperparathyroidism (2HPT). In the trial, OCT was administered three 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, at the end of the trial, PTH was decreased by over 30% in 51.6% (64/124) of the patients, and the levels of bone metabolism markers such as alkaline phosphatase (ALP), bone ALP, and tartrate-resistant acid phosphatase (TRACP) were significantly decreased 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 level. Hypercalcaemia, which was diagnosed in 33.1% of patients, was found to resolve or ameliorate immediately after the withdrawal or dose reduction of OCT. OCT can be administered for as long as 1 year without any major problems other than hypercalcaemia. The final doses ranged from 2.5 to 20.0 µg/HD, and the optimal dose varied among patients depending on the intact-PTH and adjusted serum Ca levels. These results suggest that OCT is a highly effective drug for the suppression of PTH levels in 2HPT, and is an overall safe drug if the dosage is adjusted for serum Ca and intact-PTH levels. This study confirmed that the long-term (1-year) administration of OCT is very useful for the treatment of 2HPT.
Keywords: haemodialysis; long-term administration; OCT; 22-oxacalcitriol; parathyroid hormone; secondary hyperparathyroidism
Notes
Correspondence and offprint requests to: Tadao Akizawa, MD, PhD, Center of Blood Purification Therapy, Wakayama Medical University, Kimiidera 811-1, Wakayama 641-0012, Japan. Email: akizawa{at}wakayama\|[hyphen]\|med.ac.jp