Nephrology Dialysis Transplantation, Vol 13, Issue 5 1234-1241, Copyright © 1998 by Oxford University Press
S Moe, M Kraus, C Gassensmith, N Fineberg, F Gannon and M Peacock
Background: Calcitriol therapy is the mainstay of
therapy for the treatment of secondary hyperparathyroidism. Oral
administration of calcitriol is necessary in CAPD patients, but no studies
have directly compared different routes of administration in this patient
population. Methods: To determine if the peak serum
calcitriol level (pulse therapy) is more important than the total delivered
dose, we randomized CAPD patients with mild to moderate secondary
hyperparathyroidism to receive either pulse (3.0 &mgr;g twice a week,
n=10) or daily (0.75 &mgr;g a day, n=8) oral calcitriol in comparable
weekly doses. The main comparison was the rate of decline of serum intact
parathyroid hormone (PTH) levels to reach the desired end-point of 100
pg/ml. The patients were dialysed with low-calcium dialysate and received
only calcium-containing phosphate binders. Results:
Pharmacokinetic analysis after a single dose of 3.0 &mgr;g (pulse)
vs 0.75 &mgr;g (daily) revealed 1,25(OH)2-vitamin
D levels to be higher in the pulse group at 3 and 6 h, but equivalent by 12
h. The area under the curve for 1 week of daily and 1 week of pulse therapy
was equal. The patients in the 2 arms had equivalent basal serum levels of
PTH (pulse=562±291 vs
daily=454±113 pg/ml), calcium (pulse=2.32±0.20
vs daily=2.32±0.12 mmol/l) and phosphorus
(pulse=1.32±0.52 vs
daily=1.35±0.26 mmol/l). The time required for the PTH to
decrease to 100 pg/ml and rate of decline in PTH were similar (time:
pulse=14.2±6.8 weeks, daily=12.2±7 weeks; rate:
pulse=7.4±4.2 vs daily=8.4±4.2%
PTH/week; P=NS). The serum calcium increased similarly in both groups.
Hypercalcaemia (>2.9 mmol/l) was rare (pulse=3, daily=2 episodes).
Conclusions: This study demonstrates that pulse and
daily calcitriol are similarly effective and safe for the treatment of mild
to moderate secondary hyperparathyroidism in CAPD patients despite higher
peak levels of 1,25(OH)2-vitamin D with pulse therapy. Key
words: calcitriol; calcium balance; CAPD; dialysis;
hyperparathyroidism; renal osteodystrophy
ORIGINAL ARTICLES
Safety and efficacy of pulse and daily calcitriol in patients on CAPD: a randomized trial
Indiana University Department of medicine, Wishard Memorial Hospital, POW 526, 1001 W 10th Street, Indianapolis, IN 462002, USA; Richard L Roudebush VAMC, Indianapolis, IN, USA; University Pennsylvania Department of Pathology, Philadelphia, PA, USA; Corresponding author at Wishard Memorial Hospital
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