Home » Drug Information » FDA Approved Drugs » 1998
Medical Areas: Endocrinology | Nephrology
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The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Abbott Laboratories
Approval Status: Approved April 1998
Treatment Area: secondary hyperparathyroidism associated with chronic renal failure
Zemplar (paricalcitol injection) has been approved for the
treatment of secondary hyperparathyroidism associated with chronic
renal failure. Zemplar is the first vitamin D analog available to
treat secondary hyperparathyroidism.
In three placebo-controlled studies, chronic renal failure
patients treated with Zemplar achieved a mean parathyroid hormone
(PTH) reduction of 30% in six weeks. Additionally there was no
difference in incidence of hypercalcemia or hyperphosphatemia when
compared to placebo.
In four, placebo-controlled, double blind, multi center studies,
there was no significant difference in the incidence rate for
adverse events between Zemplar and placebo-treated patients. The
three most frequently reported events in the Zemplar clinical
studies were nausea, vomiting and edema, which are commonly seen in